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Medical Devices

Transcript for 510(k) Implementation: Discussion of an On-line Repository of Medical Device Labeling, and of Making Device Photographs Available in a Public Database Without Disclosing Proprietary Information, April 7, 2011


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April 7, 2011
8:30 a.m.
FDA White Oak Campus
10903 New Hampshire Avenue
The Great Room (Room 1503)
White Oak Conference Center, Building 31
Silver Spring, MD 20903


CDRH Deputy Director for Science






AARON MOSKOWITZ, Executive Director, Biomedical Research and Education Foundation (BREF)
JEFF SECUNDA, VP Technology/Regulatory Affairs, Advanced Medical Technology Association (AdvaMed)
LISA WINSTEL, National Family Caregivers Association


ELIZABETH GEORGE, Vice President of Global Government Affairs, Regulations and Standards, Philips Healthcare
BRIAN CONNELL, Medical Imaging & Technology Alliance (MITA)
TAMIMA ITANI, Vice President of Global Regulator Affairs, Boston Scientific
MARK BAYER, Vice President of Business Development, Reed Technology and Information Services


ALEXANDRA BENNEWITH, American Association for Homecare
STEVEN BINION, Beck and Dickinson
BRIAN CONNELL, Medical Imaging & Technology Alliance (MITA)
ELIZABETH GEORGE, Philips Healthcare
AARON MOSKOWITZ, Biomedical Research and Education Foundation
MARCIA NUSGART, Coalition of Wound Care Manufacturers
LISA WINSTEL, National Family Caregivers Association


DAN ANOWI, Georgetown University
PETER BLOMBERG, St. Jude Medical
MICHAEL BURKE, RTI International
MARK LEAHEY, Medical Device Manufacturers Association
TIM TALCOTT, Smiths Medical
ANN ZOREN, Baxter Healthcare Corporation


(8:30 a.m.)

DR. MAISEL: Good morning. Thank you for joining us here today. My name is Dr. William Maisel. I'm the Deputy Director for Science at FDA's Center for Devices and Radiological Health. And on behalf of the FDA staff here today, I'd like to welcome you to today's public meeting. And as you know, we're here to discuss some specific items related to our implementation of the 510(k) program changes.

In September of 2009, FDA launched a comprehensive assessment of our 510(k) process to determine whether changes should be made to the program so that it can better achieve its two goals of making available to consumers devices that are safe and effective and fostering innovation in the medical device industry.

The final reports, containing 55 recommendations, were published in August 2010, and we've engaged in extensive public outreach through meetings like this to solicit feedback. And, in fact, we had two public meetings, we've had three public dockets, we've had town hall meetings throughout the country, and we've had many smaller stakeholder meetings as well.

In January of this year, after reviewing the public comment, the Agency announced actions it would take to strengthen the 510(k) process, and we announced that there were 25 actions to implement 47 of the 55 recommendations that we were planning to take, including the development of new guidance and enhanced training.

In keeping with our commitment to transparency and stakeholder collaboration, we're again seeking public input from you today. As you know, the two topics we're discussing at today's meeting are part of our plan to strengthen the 510(k) program, specifically by developing an online labeling repository for all medical devices and to have photographs of cleared and approved medical devices publicly available.

Both of these topics speak to making more information on the use of medical devices available for the public. The Agency's Center for Drug Evaluation and Research already maintains such a repository for drug labeling, and we'll be discussing that resource in a session later this morning. So we know that there is a way that this can be done to keep proprietary information secure but also empower patients and healthcare providers with the latest directions, cautions, troubleshooting tips, and other critical information about medical devices that they use or have implanted in their bodies.

We also recognize, however, that simply dumping this information into a database and making it immediately available may only serve to confuse and confound patients and healthcare providers. We recognize that, unlike drugs, portions of the medical device labeling may not need to be posted online and may not be necessary. For example, is it necessary to post the installation manual for a CT scanner or an MRI machine?

Today's discussion will go a long way towards helping us create a practical labeling repository that provides clear and useful information, that serves consumers well and meets their needs, and that is reliable and easy for manufacturers to use. We're really here with them to hear what the challenges are, what we're trying to accomplish for patients, consumers, and healthcare providers, and to hear the challenges that industry faces in trying to accomplish this goal with us.

We recognize the time, effort, and resources it takes for you to be here today, and we very much appreciate your presence and input. And we look forward to a productive day.

Thank you.

MS. WEICK-BRADY: Thank you, Bill.

And, again, thank you for coming today. We do appreciate you coming here to join us at FDA to talk about something that's very important regarding medical device labeling. There are representatives from FDA, from consumers, from healthcare practitioners, and from industry, and we value each and every one of your opinions. So please feel free to speak up today. That's why we're here.

If you registered to speak during the public comment period -- and right now we only have three -- please give our transcriptionist your business card so that we get your name clear when we have this transcribed. If you do want to speak during the public comment period, there will be time for you and just head up to a microphone at that point. And that's about 1:30 this afternoon that we'll be starting that.

Now, there's two important things I want to let you know. We are in a confined space here. You cannot wander around the FDA buildings during break or anything like that, so this is a bit of a confined space. However, we do meet your needs here. If you step out and go to the right down by the guard's desk and then go right again, there are restrooms there for you to use.

Also, during the breaks and during lunchtime, we will have food for sale, including coffee, if you need that. You can bring that in here. Just be very, very careful with it. If you need to step out while -- if you get a phone call or something like that and you have to step out -- you can go right outside here, there are chairs there, and this meeting should be getting announced out there as well.

So with that in mind, I want to welcome you again. My name is Mary Brady. I've been working on the labeling initiative here at CDRH for a while now. And we'll get this straight here. Okay.

So why are we doing something like this? What is the problem? Is there a problem? Well, we feel that there is a problem, and we feel there's a problem in a couple of different areas. We feel that there's a problem in that labeling really has no single centralized source where you can access it for medical devices. We feel that, you know, drugs has a lot of different places. There's been the PDR around for years. We have DailyMed. We have Drugs@FDA. There is no place where you can find all medical device labeling.

Another issue with device labeling is that it is easily separated from the device because it goes into a clinical situation and it goes into the biomedical engineering department and the labeling usually stays down there; and then people receive an in-service on the device and then it moves around from unit to unit. Or it can end up going into a home environment where the labeling stays either with a distributor or it just does not get to the end user.

Another problem is that devices have many components and accessories, and if you don't have the labeling, you may not know what accessory or what component is compatible with your device. So this, we feel, is another problem. If you don't have the labeling, you can't find that. Also, devices are used by both clinicians and non-clinicians. They're used in clinical environments, and they're used in non-clinical environments. They're used here. There might be somebody with a medical device here today. So we have to understand that devices are moving around in many different areas and they're being used by people who are old, people who are young, people who are experienced, and people who are non-experienced.

Devices can be in service for many years. They can be out there, what we call legacy devices, they can be out there for many years. I've known of 20- or 25-year-old devices that are still being operated, and they're being operated fine, but they remain out there in use.

And, of course, devices are sold or distributed across many different areas. They might be sold from one hospital to another. They might move from the hospital to their home care agency. They can be sold on the Internet; we've seen that happening. So devices stay very portable.

Okay. They're going to challenge me here, aren't they? Okay. Another area where we feel there is a problem is that people want to know about available devices and choices that they have. So people are interested about what is out there for me to use; I have a glucometer here and what it is that I want to use. They need an easier way to find out, has FDA cleared or approved this device, is this something that I want to be using that I feel safe using. And they do want the instructions for use. People are taking more control over their own healthcare, and they want to know about their product and they want to know how to use it safely.

Another area where we feel that there is a problem in that manufacturers are allowed to claim substantial equivalence to a certain device that may already be out on the market under the 510(k) process. This is allowed and it's fine. What is very difficult sometimes, though, is to find the labeling to which they are claiming their substantial equivalence. And so we feel that having something like a labeling repository might help take care of that issue.

And manufacturers justifiably don't always keep all of their labeling up on their websites. They want to promote their newer devices. They are supporting their newer devices, and of course, they do support their older devices as well, but a lot of times, all of the labeling for their devices is not up on their website. And it's becoming more and more frequent that you do have to register when you get to a manufacturer's website in order to find your labeling.

Okay, so why are we doing this now? Well, the regulatory process is definitely changing from paper to electronic. FDA has joined the electronic world as well, and this is another way in which we can participate electronically. Congress told us that we can do this. We do have statutory authority that has existed for many years. We just did not take advantage of this because there was no place to store all of that paper before. And now that we have the electronic means through the FDA gateway to accept this labeling, we want to go down this path.

The Center for Drugs, as I said before, has a repository and it is used extensively. And there are two different ones: the FDA Drugs@FDA, and we also have the DailyMed site, and you'll be seeing a demonstration of that later on this morning.

And we also believe that consumers are relying on the Internet as a valuable source of good medical information, and FDA wants to be a part of that.

Okay. It also promotes different initiatives that we have at the department level and that we have at the FDA level. It promotes the National Plan to Improve Health Literacy, and essentially, what that means is that we want to make sure that understandable information is communicated to the people who need it.

It promotes the goals that are set by Health and Human Services. I'm not going to read all of this, it's up there for you. But I think the strategic goal at FDA really encompasses all three bullet points here in that it empowers consumers for better health.

And as Bill Maisel was saying earlier, it promotes the 510(k) recommendations. Joyce Whang will tell you a little bit more about the task force and the 510(k) recommendations. Essentially is that we want to improve device labeling and develop an online, publicly available, searchable website for device labeling.

I want to state this bullet point, which is not in the recommendations, itself, but it would exclude proprietary information such as technical manuals, service manuals, operator manuals, and things like lockout mechanisms for healthcare practitioners. If they don't want their patient to see how to change a dosage or anything like that, it would not be included on this site.

Okay, I'm not going to do a lot with the regulatory process here. Essentially, this is just showing our authority of where label and labeling are listed in some of the areas of our law. Labeling is the important thing here, and we tend to use label and labeling interchangeably here, but labeling is the big umbrella. And that includes things like the technical manuals, the service manuals, promotion and advertising materials, clinical studies that the manufacturer may have done, the packaging itself, the package insert, the instructions for use, so labeling is the all-encompassing portion of what manufacturers need to send to us.

Under this proposal for a labeling repository, we would be looking at what we call the label and the package insert. This is what we are allowed to ask for under registration and listing for labeling. So this labeling repository would include a label and package insert. I want to emphasize that the term "package insert" has not been defined, but it is in the statute, it is in the act given to us by Congress, so it is a term that is there that has to be used.

Okay. Now, today is a day of options. We're looking at options. FDA has started down a path -- it is not a road, as I was telling somebody earlier. It is not a road, it is a path, and we're looking at this, but we need input from people who could potentially be using a website or using labeling for any type of use whatsoever. So we're considering this a day of options.

The first option that we have is to continue on the way that we are, and that is to do nothing. And nobody would receive information in one set repository.

The second option we have would be a government sponsored site. And I put down FDA or the National Library of Medicine right now because these are two ways in which we're looking at doing something like this. You will see the demonstration by Stuart Nelson of the NLM DailyMed site in just a little bit.

We could go down the path of a repository by an outside organization and have them take care of the matter for us. You will see a demonstration by Aaron Moskowitz, who will show you what they have with the Medical Device Registry, which is a small subset of medical device labeling. And he'll talk about something that they're doing as an outside organization.

We could do something like having a URL repository site where there would just be a site where you would go on and have the URLs of all the manufacturers' websites. And Jeff Secunda of AdvaMed will be talking about different options that industry could propose to us, and this might be one of them.

What we're asking from you as well is, is there anything else that we haven't thought of here? Can you give us some thought processes as to what you think would be a good way to access medical device labeling in one place?

So I'm going to talk about an FDA-sponsored site, remembering that this is an option that we have, that we have been thinking about for a while.

The first thing is that the labeling would be submitted through the registration and listing process. This is the regulation that says we can ask for the label and package insert portion of the labeling. And as I said, package insert is not yet defined. We will be asking you for your input on what should be package insert.

And then it comes down to which devices -- and Dr. Maisel said a little bit about this, too -- which devices should go up there? I mean, you can go anything from gauze to toothbrushes, to heating pads to ventilators, to MRI equipment, to in vitro diagnostic reagent materials. Which devices should go up there? Should it be all of them or should it be a subset?

If we were to choose a subset, what would that subset be? And if you were to go down a subset route, would you ask for all of the components and accessories and how to use those as well? So it's a very complicated area, but you have to think of this: what would you want, as a healthcare practitioner or a consumer or industry, to have up there so that you can get the information that you need on a particular device? So be thinking in that direction, which devices would best be up there?

And then, on top of that, what type of information should be up there? Should it just be a highlight section only where we're kind of going down the road of calling this a quick guide, where it would be one or two pages that you could just pull up and say oh, this will help me to set the device up, operate it safely, and stop it or clean it and maintain it? Should it just be a highlight section or should it be all of the other information?

There are some instructions for use for some of the more complicated devices like hemodialysis equipment, where you might have a 250-page user manual, and you may need all of that information because you're not sure how to mix your dialysate, for example.

Should all of that information be up there? Or if you do put it up there, should it be all together or should it be separated out by different areas like warnings, precautions, and indications?

The other type of information we're asking now, should we have both new and old labeling up there? I told you about the legacy devices, things that are out there for 20-25 years that are still functioning just fine. Should we have that labeling up there so that you can access that if you need it to find out oh, I don't remember how to clean this or my battery finally died; not what do I do to replace that battery and I need to find that information? So we want to hear from you. Should both new and older labeling be up there?

Another area that we're discussing is a standard content and format of labeling. So if you're looking at drug labeling, you can see that they have gone to a standard content and format. You always know where the black box warning is going to be, you always know where the indications are going to be, you always know where the clinical studies are going to be. So it's a standard content and format for both over-the-counter and prescription devices. Is this something that we should be doing with medical devices? Finally, how do we make this available? Is a labeling repository on a website the way to go? If it is, how do we access it? What is the best way? If you're a busy healthcare practitioner or a busy user, how do you get to your labeling quickly? And do we look at barcoding? Do we look at just having the URLs? Do we look at developing a mobile application? What do we do in order to make this easily accessible and easily searchable?

Okay, so those are our thoughts of how we would develop a website, and these are the other thoughts that we have about what you could do with a website. Okay.

So you would have the ability to download the information you need, and here's where we also want your feedback. These are just thoughts. This is not an all-inclusive list, but these are some of our thoughts: that you could download information on the patient highlight section or the quick guide; instructions for use that you might need and maybe downloading just the portion that you need; looking at the marketing information or the marketing status, meaning is this active, is it out there, is it being marketed, has it been recalled, is it still out on the market but no longer supported by the manufacturer; would this be valuable information for you to download, to say okay, this is what I know about this particular device.

Looking at compatible accessories for that device, knowing that the manufacturer would only put on their information for their labeling but for example, tubing: sometimes there's generic standard tubing that can be used with many different products and sometimes there's just custom tubing that is specific to that device. Would you want to know that? Would you want to be able to download that information?

Another area would be any pictures, graphs, or tables -- and I know we'll be talking about pictures. Joyce Whang will be discussing the photographs of devices. And is this something that you would want to have on there that you could download and say yes, this picture matches what my device looks like so I know that I'm getting the correct labeling?

Another thing that you can download would be basic care and maintenance. This would include cleaning: how do I clean it, with what do I clean it, how do I calibrate this, how do I keep this that it's working properly, so that you could have that information quickly.

And, of course, contact information. And this would be the manufacturer's website and their 800 number that you could call them at any time and be able to be in contact with somebody. So that's one of the options that we have for what we want for you to be able to do on a website. Also, we are discussing archiving older labeling, so you would have the most recent labeling available right on top, that's the one that you would search on. But if you had an older product, let's say yours is now three or four years old and you want to find that information, that you could type in something about your product and that archived labeling would come up. And, also, we're discussing having both instructions for use for both healthcare professionals and for consumers on that site.

Now, we think there are a lot of benefits and there are benefits to everybody, so I'm going to talk about the benefits for having something like this. And here, first off, the benefits to FDA.

So as I told you earlier, manufacturers tend to say that we're a substantial equivalent to another device that is out on the market, and that is what they can do. So when we get that in as a pre-market submission, we can easily go to the website and say yes, indeed, this predicate device does match up with this pre-market notification.

Some of the devices that we have mostly are Class I over-the-counter products, don't have to come in for pre-market review. So we don't see that labeling at all. Having that information up on the website would allow us to be able to see what the manufacturer has put on their package insert and their label.

In the area of post-market, we have a bunch of analysts that review the adverse events that come in with the medical devices. One of the things that they absolutely have to have in order to analyze properly is to get the labeling of a particular product. So what they have to do is they have to write a letter to the manufacturer and say could you please send me your labeling for this product. So many weeks later, they finally receive that labeling and then they can analyze a product. So this would give them real-time analysis of labeling instead of waiting for that labeling to come in.

We could also do real-time analysis during investigations and any public health notifications. If we have a recall event, we could get that labeling right away to do our analysis. We feel that investigators would be able to download the most current labeling before they go for an inspection. In the area of compliance, we feel that our compliance people and promotional advertising would be able to spot any inconsistencies a lot quicker.

And as I was saying, if we could develop very good search capabilities, we would be able to find things a lot quicker. We had an incident with heparin a couple of years ago and to be able to find all of the products that had heparin in it was very difficult for us. But if we would put in search criteria where we could find things like allergens and other particular materials, we would be able to find this information much more quickly, and of course, that does benefit the public health.

We believe that there are benefits to consumers and healthcare professionals. We believe that having immediate access to labeling and in one place saves you time and possibly saves you a patient. I have talked with emergency care physicians, and they say if I had access to that labeling with that person who came in to the emergency room with that medical device, I might have been able to do something a lot quicker.

They can do informal comparisons. So if you have a glucometer and you say is this the best glucometer for my needs, you could possibly do an informal comparison of all of the glucometers up there that have been either approved or cleared by FDA for marketing.

Hopefully, labeling changes would be immediately available and easily accessible. We'd be working through that process to see how quickly a manufacturer would have to send in their labeling updates. But we know that there are problems, like in hospital situations, where manufacturers are very diligent about sending in their updated labeling.

The labeling then goes to the biomedical engineering department or the nursing department where it's nicely put into a little binder and into a folder and never really sure if it ever gets to the end user so that they know what the updated labeling has.

We also believe that physicians could use this for e-prescribing. They could find out what different types of a product are out there, knowing who their user is and how they could get the best product for that particular user.

And, of course, as I said before, older labeling could be archived and it could be searchable, so you could be finding out about older devices on this.

Okay. And now we think that there are benefits to other organizations as well. Other government agencies such as the Center for Medicare could be looking at this for any problems with fraud. There could be testing by standards organizations on their claims for intended use. They could be working as third party reviewers for us or they could be looking at devices as they're developing standards or assessing standards and seeing if this, with the real-time labeling, what's going on with the intended use and what is on the labeling.

And we also believe that there are benefits to manufacturers here. As we are going electronic and everything is going through this FDA gateway, we are providing a consistent approach for manufacturers to send in all of their pre-market and post-market information, so we believe that by providing this same gateway for electronic labeling, that this would help the manufacturer time-wise and possibly money-wise.

Only FDA-registered and listed companies could be up on this website. I was at a conference back in the fall and somebody came up to me, a small manufacturer who makes TENS units -- it's a very small company, less than 50 people -- and she said to me, What can FDA do about this problem? We have registered and listed with FDA. We have done everything right. We have good labeling; we had it reviewed. It is now a prescription device, and we are marketing this the way we're supposed to be marketing this, but we have all of these other companies coming in who don't register and list with FDA, and they are marketing theirs on catalogs, online on their websites, in magazines, and they are taking away our business.

So we're hoping that having a site where it is FDA-registered and listed products could help diminish that problem. We can't be assured of that, but we're hoping that that could be helpful.

We would definitely provide links to the manufacturers' websites and their 800 numbers. And we also believe it would decrease that cost of sending in that labeling when the analyst asks for that labeling during adverse event reporting.

Okay. I have two pages of benefits to manufacturers, so -- they can inform the public when they are no longer marketing or supporting a product. It could go up on that site, and they can say we are no longer supporting this product and we recommend that you go for a newer product, which is probably safer as well.

It would be a link to the Unique Device Identifiers. If you're not familiar with that, I'm not getting into UDI today, but it's technically a barcoding system, another thing that Congress told us we needed to do, and it is barcoding of medical devices. So that is something that's in the process right now, and we would hope that this would be a link to UDI.

We'd have increased assurance that customers have access to their most recent labeling so that they could get that updated labeling up there as quickly as possible, and people would know that they could go to that site and find that updated labeling instead of going up to the tenth floor in the hospital and trying to find it in a binder somewhere.

And, also, when I was talking about the predicate devices and finding their device is substantially equivalent to something already out on the market, they could get improved information as well about that product.

Okay. We have a lot of activities that go on with labeling on a daily basis, both in pre- and post-market. We have some additional activities that are going on here, and I'm just going to let you know a little bit about them.

There is a questionnaire that you might have received when you came in today, and we have one for industry, one for healthcare professionals, and then one for consumers. And we encourage anybody who feels that they meet any one of these different sections to go ahead and fill that out. It will only take you five minutes, and it will just help us gather a little bit more information. Some people are very shy about speaking in a public meeting, so we have this available for you to respond to.

If you do not want to respond to it today, we will also have it online where you registered for this public meeting. You can go up online and you can answer the questions there. And we would really appreciate it. That will remain open until May 10th.

If you feel that you meet more than one criteria, you are free to fill out more than one of these questionnaires today. I think we're all consumers in one way or another.

We are doing focus groups with healthcare practitioners and laypersons, and we are receiving information from them about what is important to them in labeling, what labeling means to them, how do they access labeling, what do they think about labeling. What would be the best way for them to see this, what moves them to want to read the labeling, and which portions are important to you when you're getting labeling. So we're in the process of gathering that information right now.

We also have a medical device labeling pilot. This started out as a home use initiative, getting labeling to patients in the home, and it has expanded, of course, much more broadly now. But we are doing the pilot with just manufacturers who have devices labeled for home use. This is going on through the middle of August, or I think it's going to be the end of August now, and basically what we have been doing is we've been developing a template for device labeling similar to a form where you would fill in all of your information so that it would go through this electronic gateway and come out and be searchable and readable.

So we're working with the manufacturers, and there are six manufacturers. We have a couple of small ones, a couple of medium-size ones, and a couple of very large ones who are giving us information on their already-marketed devices, and it has been extremely helpful because some of them have very complicated devices and we need to know what we're missing.

So, essentially, they are reacting to things that we are developing, telling us what needs to be changed, and then we change it and bring it back to them and they react again. So it's been pretty painless for them to be a part of this pilot, and it's been extremely helpful to us for them to have been a part of this pilot.

If you are interested and you are a manufacturer and you do want to participate, we can get you caught up if you want to be a part of this. That goes through August.

And I want to thank you for your time. Please hold your questions. We'll have a panel session at the end of all of the FDA speakers, and I'm going to ask Joyce Whang from ODE to come up and talk about photographs.

DR. WHANG: Good morning.

Another topic for today's workshop is whether medical device photographs should be routinely available through a public database. There are some devices for which photographs are already available on the FDA website.

Here you see a photograph of a recently approved renal stent, a pacemaker, and a digital mammography system. Because these devices were approved through the PMA process, the FDA website includes photos of the devices as well as information about the approval order, the basis of approval, et cetera.

Healthcare workers are accustomed to finding photographs of drugs through the PDR. They may use these to distinguish dosages of different pills or to see the applicators or sometimes the packaging that a drug is provided in.

For most medical devices, photographs are not routinely available. And so we're asking you, should photographs be available for more medical devices, and if so, how?

Now, I showed you photos from the FDA website for PMA devices. Now, this is the method for approving the highest-risk medical devices, but they represent a relatively small fraction of the medical devices being used.

A much larger category of devices is cleared through the 510(k) process. And as you've heard today, the 510(k) program has been under some internal review. A report was issued last August by the working group which recommended, among other things, that the Center provide a publicly available and easily searchable database that would include 510(k) summaries, photographs and schematics of devices to the extent that they do not contain proprietary information.

This report was put out for public comment. There were comments that were generally supportive of having a public database, especially for accessing 510(k) summaries. There was widespread concern about having detailed photographs and schematics available to the public if they might contain proprietary, confidential information.

And there was some support that having a public database may help manufacturers select more appropriate medical devices or more appropriate predicates for their devices.

In January, the Center issued another report, which summarize these comments and put forward some next steps. First, FDA reiterated its intention not to include confidential, proprietary information in a public database. FDA also proposed that manufacturers be requested to provide photographs that were suitable for public display and could be included in a database.

We recognize that the use of the term "schematic" may have created some confusion because schematics can refer to detailed drawings, and so you'll see our discussion today is about photographs.

To the extent that 510(k) submissions may include more detailed photographs or schematics as part of the submission, these would be for internal use only, as part of the review process. They would not be part of a public database; they would not be available by request through the Freedom of Information Act.

And given the comments that were received on this recommendation, we said that we would seek additional stakeholder input through a public meeting before taking steps to implement the revised procedure. We want to make sure that we've addressed the concerns that were expressed and that we're meeting stakeholder needs. So this is part of why photographs are part of today's meeting.

Now, if photographs were to be made publicly available, how should that be done? The 510(k) report suggested that they could be provided along with 510(k) summaries, which are already available on the FDA website but could be made part of a database.

There are other options as well. For example, including them with a broader labeling repository. Now, this would have the benefit of including more devices, not just 510(k) devices but also the high-risk devices that are approved through PMAs and also the so-called exempt devices, which can go on the market without FDA review. And, of course, we're open to other suggestions you may have.

So what are some of the benefits of including photographs? First, it's just more information about devices. A picture says a thousand words. Having photographs may help enhance people's understanding of medical devices.

Second, having photos may assist patients or healthcare workers with identifying devices. If somebody's looking at the labeling for a device, to be able to see a photograph might help them know that they're looking at the right labeling for the device they have in mind. A patient who has a device, who wants to make sure they know what the device is, may find the photos helpful. Or if there is a recall and you want to know exactly what devices were recalled, the photographs, again, might be helpful.

And as stated in the report, there is some expectation that having photos available may help manufacturers to select appropriate predicate devices for 510(k) products.

So we have a number of questions that we're hoping the speakers today will be addressing and that will be brought to the panel discussion this afternoon. In relation to photographs, the first is: Should photographs of medical devices be made available to the public? And I ask you to think about what are the benefits, the drawbacks, who would use the photos.

And the next: How would this be implemented? Should there be some types of guidance or requirements? Essentially, is this a voluntary activity, or is there some mandatory component of it? If there is some mandatory component, should there be some definition of what devices need photographs? Are there some devices, perhaps software devices or in vitro diagnostics, for which photos aren't really that meaningful? And are there any other recommendations you would like to make about how this would be implemented?

And, finally, regarding the concerns about the sharing of confidential or proprietary information, if we have companies submit photos specifically for a public database, is that sufficient to address the concerns about proprietary and confidential information?

I look forward to hearing your thoughts on these questions today. Thank you for your attention.

The next speaker is Laurel Mendelson. She's from OCER, the Center's Office of Communications, Education, and Radiation programs. She's from the Division of Health Communications, and she will be speaking about the content of medical device labeling.

MS. MENDELSON: Hi, good morning, and thank you all for coming today. We really appreciate everyone showing up this morning to talk to all of us about labeling and about improving our 510(k) process.

I think everyone here came today to this room because we all care about patient labeling -- patient labeling and professional labeling. We think that we are all here because we have something to add to the process and we believe that the labeling, in general, is a key communication tool between healthcare providers, industry, and patients.

As Joyce said, I'm Laurie Mendelson. I work in the Division of Health Communication, and one of our primary goals is to review patient labeling. I'm particularly interested in the contents of labeling. As we're looking forward to some sort of defined registry, some sort of more defined process for collecting labeling, illustrations, pictures, I think we also have to take a step to the side and also consider, are we following the best practices for writing the labeling and for distributing the labeling?

My division reviews patient labeling. We only look at the information that goes to patients, consumers, their caregivers. Other divisions within FDA look at the professional labeling. So I admit I have a slant toward patient labeling, but until the end of the presentation, I'm going to try to be a little bit more general.

Over the years, we've studied what makes labeling clear and unclear and understandable to the users. And we've also developed quite a bit of guidance and training on those topics.

In our reviews, we look at patient labeling and professional labeling as a key form of risk communication. Is the labeling appropriately conveying the benefits versus the risks so that people can make the decision whether to use a device, to select a device, to prioritize the instructions in the device, like we might see here, and do they have enough information to treat patients and treat themselves appropriately?

For the first couple of minutes of this presentation, I'm going to review the rules and regulations that allow us to collect information in labeling, and then I'm going to share with you some of the guidance that we use now. And, finally, at the end, I'm going to ask you if you have input into what should be our guidance for the content of labeling for the future.

Back to the boring slides. Although we all have an intuitive idea of what labeling is, the Food, Drug and Cosmetic Act actually defines it for us. The labeling are the labels, the pieces of information that are written or printed directly on the device or its packaging, and the materials that accompany the device.

So here you see some labels on the immediate container. It might come on a bottle, it might come on a box, it might come on the plastic wrapping, it might be stamped directly on to the product itself. Or it might be the materials that are packaged together with the device when it arrives either at the hospital or the healthcare facility or the drugstore or the home. The materials that are packaged with the device have been kind of open to interpretation over the years. The labeling, itself, includes the brochures, the pamphlets, maybe the videos, the posters, in some cases, the advertising. All of these are considered the labeling that comes with the device, and it doesn't even have to actually arrive with the device. For more than 50 years, the courts have upheld that labeling that accompanies the device doesn't actually have to accompany it at the same time. It can accompany it through a separate shipment, through separate delivery.

Again, back to the Food, Drug and Cosmetic Act. A device needs to contain both adequate directions for use and adequate warnings to protect the user. A device is actually considered mislabeled unless it contains both of these pieces.

And in most cases or in many cases, medical devices need to include information for the layman or the layperson. From the regulations, a medical device must have adequate directions for use unless it falls into a couple of very distinct categories: if it's a prescription device used only by healthcare providers and it contains warnings right on it, or it has such commonly known directions that it doesn't even need to be labeled.

When we look at medical device labeling, the Food, Drug and Cosmetic Act directs us to look at the labeling in slightly different ways for PMAs, our highest risk devices, and 510(k)s. What this really says is that when we receive the PMA applications, we must receive a full copy of the device labeling so that we can use the labeling, itself, in the determination of safety and effectiveness, in determining whether the device should be approved or not approved.

With 510(k)s, the law is a little bit different. Companies either have to submit the full labeling or a portion of the labeling, and FDA uses that in determining substantial equivalence.

Guidance. We use this foundation to develop our guidance. When FDA reviews labeling, when we review labeling, we depend very much on both our own guidance that we've developed and on our professional experience. You know, as I think everyone in the room knows, unlike the title of this book, it's not for dummies. It's a complicated process. It takes skills to develop labeling, it takes skills to write labeling, it takes skills to review labeling to make sure that it's meeting the needs of all of the audiences.

FDA has two primary guidance documents that we have developed to assist our own reviewers in reviewing labeling and to help industry in developing the labeling, developing the content for the labeling. These have good government names, the Device Labeling Guidance G91-1 and the Guidance on Medical Device Patient Labeling. You all here, I hope everyone in the room knows these and is familiar with them.

But in the Blue Book memo, this is the primary guidance that we use to help us understand and to help industry develop what the contents for professional labeling should include. We know that it should include the indications for use, the contraindications for a particular device, any warnings, precautions, limitations for special patient populations, and any adverse reactions that are associated with the device.

The Blue Book memo doesn't go into great detail about the contents for patients, but it does give a little bit of background information about when is patient information appropriate for prescription devices. It includes if a patient needs to be aware of any alternative devices if they have choices in the matter; if there are particular risks higher than one might expect or any particular discomforts associated, then there needs to be information for patients.

If there's a need for strict adherence to some sort of regimen of care after a procedure or after a device is used or implanted, then there needs to be information for patients. And if there's some sort of controversy that exists surrounding the medical device, again, there needs to be information for patients.

When we specifically look at the patient labeling, we feel like we need to go a bit deeper than that. The medical device patient labeling guidance talks about what is medical device patient labeling and what constitutes it. No surprise that we consider medical device patient labeling any information that's associated with a device that's targeted to a patient or a consumer or a caregiver who takes care of a patient.

The whole point of the patient labeling is to ensure that the device is used safely and effectively even in the absence of a healthcare provider or maybe together with a healthcare provider just to ensure the best possible outcome.

And when the guidance was written in 2001, it talked about what constituted medical device labeling as brochures, leaflets, user manuals, maybe an occasional videotape. We all know that the world has changed in ten years, and we'll talk about that in just a minute.

There are two key elements that need to be included in every medical device patient labeling: risk/benefit information, so that people can decide whether to use a device, whether to select a device or have it used on them, and so that the users can become aware of any particular problems with the device; and instructions for use, the procedural steps for setting up, using, cleaning, troubleshooting, storing a device.

Again, this document talks about when you need specific risk/benefit information, and it talks about if a patient needs to be able to decide whether or not to use a device or to have one used upon them, or to pick one out in the drugstore or to select among similar devices or device procedures, then they need to have risk/benefit information there so that they can make an informed decision.

They also have to be able to respond to a healthcare provider, to be able to say I have this particular condition, or I have this device already implanted in me, or I'm allergic to this material. They have to know what to tell the healthcare provider when they say do you have any reason why I shouldn't be doing this procedure with you, and they have to really fully understand what they're getting into, as informed participants in the healthcare process.

And then there's instructions for use. These are kind of a separate set of information, but again, patients and consumers need the instructions-for-use part of labeling when they, themselves, are the ones who operate or use or manipulate the device in some way. Or if they're the ones who maintain it or clean it or store it. Maybe they need to monitor the output of a particular device, like a glucose meter or a cardiac monitor of some sort, and report that information back to their healthcare provider. Or maybe they're training a particular caregiver or telling their parent or child or friend on how to treat them.

People also need instructions for use if they're thinking about how to alter their lifestyles or their care regimens to integrate use of the device. Do they need to change what they eat, how they exercise, where they go? And, finally, they need to know how to safely dispose of the device. So how is medical device labeling provided and what should be provided as part of medical device labeling? It's a good question. In 2001, we talked about the formats being maybe posters, booklets, pamphlets, brochures accompanying the device. We talked about, you know, that sometimes we would see a videotape as part of the labeling. And the world really has changed since then.

What do we consider labeling now? Do we consider labeling promotional material on a website? Do we consider labeling to be something that you receive as a podcast or something that comes maybe to a handheld portable device, maybe you access it through some sort of app? The formats are different, and I think we need to think very hard later today about what kind of formats are really part of medical device labeling.

So as I wrap up here, I just want to leave you with a couple of thoughts that I hope you'll consider answering either in our panel session later, on the questionnaires that Mary talked about earlier, or through our docket or the questions to end here, but give us your input. That's why we're here.

What types of devices, first of all, most need patient or consumer labeling? They don't all need it. I think we'll all admit not every device needs patient or consumer labeling, but some do. Which are the ones that need it?

What's the most important content to include in labeling that goes to professionals? What about patients receiving prescription devices? What about consumers who are picking out their own devices for themselves? What content needs to be included here?

What should be any special considerations for putting into labeling for over-the-counter and home use devices? What should the contents be?

What does labeling mean in an electronic world, and what should we consider to be the various components that make up labeling and should go into some sort of collective or repository?

And, finally, what can we do, as FDA, to help you make labeling better? We would like to see all labeling be good, solid risk communication tools for healthcare providers, for patients, for consumers. How can we help you do that?

I'm going to end here and turn the program over to Molly Story. Molly is a Human Factor Specialist in our Office of Device Evaluation. She's going to talk to you a little bit about enhancing labeling.

DR. STORY: Good morning. I'm Molly Story. I am a Human Factors Specialist in the Office of Device Evaluation with expertise particularly in accessibility for people with disabilities.

The group has asked me to talk a little bit about what makes labeling particularly good, maybe what we can do to make it better. And so I'd like to talk -- first of all, again, you've heard this repeatedly -- labeling is anything that's on the device specifically or on any of its packaging, containers, wrappers, or anything that comes along with it, which could be something printed, the instructions, a quick start guide, or something electronic. These days we see a lot of CDs or links to information on the web.

Labeling submitted to the Center for Devices and Radiological Health is associated with medical devices, specifically. And FDA, of course, regulates devices for safety and effectiveness. As part of this process, it's very important that manufacturers follow a program of risk management. It's a critical activity to assess and demonstrate the safety of devices to the FDA so that we can clear those through the 510(k) process or the PMA process.

As part of risk management, you need to do a risk assessment to identify all of the risks and hazards associated with the device, estimate their likelihood, the severity of the potential clinical consequences of the hazards associated with device use; and any risks that are judged through this process to be unacceptably high need to be mitigated or controlled in some fashion. Then, once you've made those changes, you need to make sure that the changes you've made haven't introduced new risks and that they are effective at reducing the risks that you had identified earlier.

Strategies for mitigating risk potentially involve changes to at least one of three things: changes to the design of the device itself; to the labeling that accompanies it; or potentially any training that may be associated with and that's provided in conjunction with device procurement. The hierarchy of preference of modifications follows that same sequence. First of all, we really prefer that you change the device, itself. If that's not possible, making changes to the labeling to either add warnings or precautions or change the ways in which you advise people to use the device can be helpful. Finally, training is the thing we'd least like to see depended on to reduce the risk associated with use of a device.

Because the problem with training is that you have to remember what it is that they told you, and it may not have been recent, it may have been a while ago, and who knows what's happened since then. You also have to remember it correctly, and that doesn't always happen either, especially if the device makes you tempted to do something else than the way you were trained to do it. This can be a real problem.

The problem with labeling is first, you have to find it. Mary talked about: maybe it's down the hall in a binder somewhere; you don't even know who has that thing. If it's at home, did you keep it or did you throw it out with the box? If it's around, then you have to go find it, then you have to actually read it, then you have to be able to understand it, and if this is something for which time is critical, this could be a real problem. You're waiting, delay of treatment is occurring while you're trying to figure out how to use the device. This is a problem. So we really would prefer that you fix the device and not depend so much on the labeling.

Having said that, what makes labeling good? There are three things: you have to make sure you're writing to the right people; you have to make sure you're communicating the correct content; and then you have to design the presentation so that that message is effectively communicated.

So who are the users? They might be professionals; they might be a very well-defined category of professionals. It may be only surgical nurses who ever use this device. That's pretty straightforward. But it may also be home healthcare aides, other professionals who work in the home. It may be the technicians or the biomedical engineers who maintain the device, who clean the device, who provide more supplies, who update the device, even. Can they use it effectively also?

Or it could be consumers. These could be people who are providing self-care in the home or their friends or family who are providing care for them.

Then there are the people that you may not expect. You may not have designed or labeled your device for home use, but it may be going there, anyway, through the practice of medicine. And so one of the major concerns FDA has is that those devices are going home potentially without instructions that were written for lay users.

Users can vary a lot. Even surgical nurses can vary considerably by age, by gender, by physical capabilities, sensory/perceptual, and cognitive/intellectual abilities.

Physical abilities: Some people may have tremor, or they may have arthritis, and so they're not particularly dexterous.

Sensory/perceptual: They may have low vision, they may need reading glasses like me, or they may be blind.

Cognitive/intellectual: Some people read at low levels, some people are cognitively impaired, some people may just be foggy because they're under medication.

All of these things need to be taken into account, and this is one reason why sometimes, especially for lay devices, you may want to consider providing labeling in alternative formats, either in audio or video on a CD, or in large print. These kinds of things can be very helpful, particularly for home populations.

Users have a wide variety, potentially, of knowledge level, experience level, literacy and health literacy. Again, for consumers in the home, it's a very wide diversity of users.

And, finally, acceptance of condition and emotional state. If someone is suddenly diagnosed with something that is terminal or will greatly affect their quality of life, it can be very devastating, not only for the patient but for their family members, and this can affect the way people use devices.

Then, secondly, determining the key content for labeling. Particularly, you want the labeling to contain the indications for use and the contraindications. You should also list the benefits of using it. Why might I want to use the device? What might keep me from wanting to use it at all?

Warnings and precautions, again, the better, the more well-designed the device is, the fewer warnings and precautions you should have to put in there. At least that's in an ideal world. My concern is that warnings and precautions often tell you what not to do, and that depends a lot on the way people read it and whether they read it at all.

Clearly, [the labeling should include] setup instructions, instructions for use, maintenance procedures, how do you change the battery, where do I get supplies, what other things might it need.

Then, finally, design the presentation, make sure you're writing the content of the labeling to the people you've identified as being the end users of your device. Keep the contents simple and direct. Make sure that you include in the labeling everything that needs to be there, but no extra words so that you will increase the likelihood that people will actually read it.

It's very helpful to use graphics, to use color. Illustrations can be very effective. Photographs, if need be, need to be very clear but they can also be useful. Graphics of all kinds can help break up the content and help communicate it, especially to people who don't read as well.

Emphasize the critical content; let other things recede. It's also helpful to break the information into chunks so that you can group a set of information, understand it as a unit before you move on. Make the sequence logical. That makes sense. Make sure that you're doing things in a normal order and natural order, in which case things proceed the way they should. And then finally, a table of contents or an index can be very helpful if people remember that that thing was somewhere in the labeling but they can't find it. They need to be able to go back and find it as quickly as possible. You can also do this physically by putting tabs on the edges or at least colors on the edges. There are things you can do to help people find their way through the instructions.

So what makes labeling even better? Test it. Go talk to people who will actually use the device or are representative of the people who will actually be reading the labeling in the long run and see if they can understand it, see if they can follow it, see if they can use that labeling, those instructions, to use the device the way that's intended. Make sure they can read those warnings and precautions and understand what it is they're supposed to do and not to do.

The purpose of usability testing is to ascertain as well as possible the way people will really use the device in the real world, and the labeling. And usability testing can be very useful for this. But you do need to make sure you're talking to people who represent the people who will actually use the device, whoever those are, and under typical conditions of use. The lighting may be very bright, in the hospital, and there may be glare. The lighting may be kind of dim, in the home, if you're in the bedroom and reading this at night. Those kinds of things can really affect the use of the labeling as well as the device, and it's important to test your instructions and your device under those conditions.

And you can have these people either actually use the device or simply describe to you what they would do as they use the device, as they read the labeling.

And I want to emphasize that when it's early in a design process, when you're still figuring out what the device is and what the instructions are going to be, with only a handful of people you can learn a lot. You don't know what assumptions you've made until you put your device in the hands of someone who has never seen it before. And with even a small group of people, you can learn a lot about what's working and what's not working for people before you go to market.

I want to talk a little bit about the difference between labeling of a company's drugs and labeling of a company's devices. Drugs really only come in a limited number of forms. They're only administered through a limited number of routes. The labeling, the user behaviors, are really quite limited, and the Center for Drug Evaluation and Research tends to provide pretty specific language about the content and the wording of labeling because they've seen this again and again and again.

Devices, on the other hand, are not so limited. They are very diverse, some are very complex, and the instructions are always different. At the Center for Devices and Radiological Health, we tend to consider labeling as one element of the user interface, in fact, and we expect manufacturers to design and test the labeling as part of that user interface.

So we do review labeling as part of the 510(k) and pre-market application process. It should be considered as part of the risk assessment I referred to earlier that will guide assessing the way people use the labeling and the device.

And if the labeling is relied on as a strategy for reducing the level of risk associated with the device, you have to make sure that the labeling is effective at actually reducing the risk through testing. And for over-the-counter products, it's especially important to confirm that people can understand the information on the outside of the package to make sure they can figure out whether the device is appropriate for them.

So, finally, to enhance labeling, you need to identify the users, whether they're professional or lay users, what kinds of characteristics may be unique to those populations of users that would affect their use of the device and the labeling. What kinds of conditions might be present during the use of the device? What environments might the device be used in?

If it's something that is used outside of a healthcare facility, it may go to work, it may go to school, it may go to the ball park. All of these things need to be taken into consideration. Determining the key content, you need to keep it simple and focused, make sure you're communicating what you need to communicate but not too much else. Design the presentation so that it's easy to read, understand, and follow, but also to handle. Is it a little booklet, is it a giant piece of paper that's accordion folded six ways from Sunday? Is it a laminated two-sided card? That also is important as part of the design of the labeling.

And then, finally, test the labeling with representative users to make sure it is as effective as you need it to be to make your device safe.

So that concludes my talk. At this point, I'd like to invite the audience to ask questions about anything about the labeling repository, the use of photographs, the content of the labeling, testing of labeling, design of labeling. Whatever it is, this is now your opportunity to ask us some questions, and we will be here to answer.

MS. WEICK-BRADY: We have roaming microphone people, so you don't even have to get out of your seat, if you don't want to.

UNIDENTIFIED SPEAKER: Can you hear me? Okay.

My question is -- I'm from industry. My question is, you talked about archiving, labeling for older devices. What about changes to labeling and updates to labeling? What kind of requirements are you thinking about that, you know, industry would have to do? Like update every time they change something on their label, do they now have to update the repository? And then what happens to that previous labeling? Does it get archived in a different place? Have you thought about that?

MS. WEICK-BRADY: Yes, we have thought about that. The how-to's are in development, but I think that's a very good question regarding what happens with all of this labeling.

Now, what has happened with drug labeling -- I might let Stuart make a couple of comments on this, too -- that the most recent labeling is what is displayed for anybody to take a look at and to search on. However, the other labeling then goes into an archive that remains searchable and usable as well. So it is only the most recent labeling that would be shown. Now, for submitting updated labeling on a regular basis, we haven't gone through how frequently that would need to happen. Right now, we're talking about the yearly basis, when you register and list your product that you bring in your updated labeling. But we do know that it happens frequently throughout the year, too.

We don't want to make this a burden on the manufacturers, but we also want to make sure that if there is important safety information that needs to get out there quickly, that the manufacturer is taking that responsibility and getting that labeling up there. Whether it would be reviewed first by FDA or that you would put it up there and notify us, we haven't worked out the details on that, but we are discussing the frequency and how you would do that, how you go about doing that.

Does that help you?




DR. NELSON: If I could talk about that for a minute.

I'm Stuart Nelson. I'm from the National Library of Medicine, and one of the things that I've done is built the DailyMed site. It seems to me that devices are, as Molly observed, quite diverse and quite different compared to the drug. And one of the aspects of it that I've heard so far this morning is the difference between the model of the device and the need to have current labeling for each model of the device as well as -- and the labeling for each one of those could change, so it would seem to me that you might want to be more specific in the labeling about which model you are talking about and maybe even have separate labels for each model.

Yes, DailyMed has an archive. We have every electronic label that's ever been sent to us that's past its validations and not been returned to the FDA because the XML didn't validate. They're all available on our site, but only the current information is what's displayed. But if you really need to see what everything was in, you know, January of 2008, what was on a particular label, you can find that.


My question perhaps continues on that thought, is the complexity of this labeling process for medical devices. Drugs have, as we've said, a limited number of drugs, where manufacturers have an infinite number of possibilities.

An example is kit manufacturers may have 15, 30 devices within one kit, and they're constantly establishing new kits for hospitals that need those at their directions.

Has there been an evaluation of the cost/benefit that the value to this and the cost to the manufacturers and to FDA in order to implement this? As my experience as a kit manufacturer with the drugs, I've experienced, through the drug listings, and I find it an impossible task to input the labeling and the listings for multiple products, multiple drugs, into that database. It's unworkable and, as it stands now, highly improbable this will be successful for kit manufacturers and manufacturers in general.

So if you could answer the question about the value added and the cost of all this for FDA and industry, I'd appreciate it.

MS. WEICK-BRADY: We're in the process of evaluating the cost of this and getting the feedback from industry to find out how difficult this could be.

One of the things that we're doing in the pilot test with the devices, we have anything from respiratory to dialysis to wound care that are being tested, and they also have kits, and they're giving us the feedback as to what would be beneficial in filling out a form, what needs to be replicated. If you have something that is the same yet there's only one or two pieces that are different in that labeling, how can we replicate that information to keep the burden down on the manufacturer when you're sending in your labeling. So this pilot is helping us determine how much of a burden that would be with kits and with special accessories, or if you're supplying things in many different sizes or in many different quantities. So we're getting that feedback right now. I can't give you a direct answer right now, but yeah, we are getting that feedback.

MS. BYLANDER: Hi, this is Jessica Bylander with "The Gray Sheet."

I'm just wondering, are you putting more emphasis on the patient friendliness of the labeling now that presumably more people will be accessing it if it's online?

MS. MENDELSON: Hi, thank you for your question.

I think we've always put an emphasis on the patient friendliness of the labeling, but it will become more visible if it's more available to more people. The whole purpose of our patient labeling guidance document was to encourage everybody to make the labeling more patient friendly, and really even more than patient friendly is patient accessible, understandable by the users. So yes, it's important, and we'll continue to make it a priority.

UNIDENTIFIED SPEAKER: Thank you, good morning. Representing industry.

I really appreciate the detail, Molly, and your presentation had a lot of good points. The one customer user requirement that was missing, however, is language. And living in a state such as Florida and Texas for the last 20 years, we're very in tune to non-English speaking patient requirements. Is this going to be multi-lingual such as English and Spanish? Thank you.

MS. WEICK-BRADY: The plan right now is to keep it in English, as it is the main language in the U.S., and that's the thought right now. However, we will take your comment back and discuss it. And I appreciate it.

DR. STORY: I would say though, also, that we're not looking to require any additional labeling for manufacturers. I believe it's simply to capture the labeling that exists. So I think your question is well taken, but it's a bigger issue. Is labeling, in general, available in multiple languages? And that may be something for labeling, in general, beyond the repository, for FDA to consider.

MR. LEAHEY: Hello, Mark Leahey with the Medical Device Manufacturers Association back here. Thanks so much for the presentations, very informative.

The question I have is a follow-up to one earlier about the resources. You laid out some options that you're considering. And I think it would be helpful, if FDA intended to do this on its own, we hear quite a bit about the lack of IT infrastructure and resource needs at the Agency, so what are the costs for putting this together, and given the current budgetary environment that we are living in and will likely live in the next couple of years, how do you envision this to be funded?


MS. WEICK-BRADY: Holding bake sales. No, I'm just kidding. No, there are various ways that we're looking into this as well. To what depth would we want to have a labeling repository and how searchable do we want to make something like this, which would then direct how much this would cost, also looking at which devices, if not all of them would go up there, and that would also dictate the cost.

There is something already available out there, though, that has been used by the Centers for Drugs, Biologics, and now Vet medicine, and it is a form called the X-form. It is not an alien form, it is just called the X-form. And it is something that manufacturers of drugs, biologics, and vet medicine have been using for a while there that is free on our Internet, and they can fill out the information at that point and then it electronically transfers through our gateway.

The cost for manufacturers has not been determined, but we are trying to keep that cost down as much as possible. We would probably do something very similar to what we did with adverse event reporting, in that we offered three different ways for manufacturers to send in their information electronically: and that would be through a free form that is available through an FDA website; or the manufacturer could ask a vendor to put together that information for them and then they would send it in; or the manufacturer could go ahead and change their internal processes. So there are three different ways in which this could be handled.

But it really does come down to what extent we want to have this information on a site and which devices and how searchable would you want to make it.

So this is all things that we're looking at right now, and we would appreciate any feedback as to what you would think would be involved in a cost like this.

MR. SECUNDA: Jeff Secunda, representing industry.

I just wanted to point out that whereas the MDR adverse event report becoming electronic is actually quite an advantage towards industry and probably even more so towards FDA, this is information that is already collected and submitted to FDA. So the cost of actually doing the infrastructure interface is just one component.

For industry to have to essentially rewrite labeling to fit into a format would then be submitted to FDA is a huge cost and one that would be ongoing as labeling is updated, changed, et cetera. So I just want to make clear that it's not so simple as just choosing a free form that FDA provides or even doing the business-to-business access that they have laid out for companies. It's the internal structural changes that companies would have to undertake to essentially rethink their labeling and reformat it for this kind of transmission.

MS. ITANI: Hi, this is Tamima Itani with Boston Scientific, and I wanted to make a comment very similar to the one that Jeff made because I think I heard that you're looking for existing labeling to be put in the repository.

On the other hand, earlier in the presentation, Mary's presentation this morning, the questions were about are we going to include highlights only, new and old labeling, standard content and format, et cetera. As Jeff said, any changes to our existing labeling is going to be hugely costly to our industry, so this needs to be definitely factored into, you know, the solution moving forward. This is not a simple endeavor.

Thank you.

MS. WEICK-BRADY: Just a comment on that. We agree, it is not a simple endeavor, and we don't want to ever make you think that it is simple. And I do agree, Jeff, that it isn't quite the same as what we have with adverse event reporting. What we were trying to find is what are the different ways in which we can receive this information.

The pilot that we're doing, really, is looking at how long is this taking, what kind of information can be replicated so that the manufacturer isn't repeating information. And they are taking existing labeling and putting it in and copying and pasting a lot of it as well and letting the coding system take over from there. We're finding it takes anywhere from -- it's been about 45 minutes to an hour and a half to get the first round in. This is what our preliminary result is for people who have never done this before.

So based on that information, we want to decrease the time and figure out what to do with these forms so that it is not a burden to manufacturers. We don't want this to be a burden, yet we believe that this is an important endeavor as well.

DR. NELSON: May I ask a question?

Have you settled on a set of common elements that belong with every label? You know, when I got into medical informatics, my first publication was about what we called expertness from structured text, and what we found out was that if you can just delimit a certain number of common elements, that the information within them becomes much easier to search out and derive good information.

And so I'm listening, and I'm saying well, what are the common elements? You know, I didn't write very many prescriptions for devices when I practiced medicine. I wrote lots of drug prescriptions, and the drugs are fairly simple in that sense in that there are fairly common elements. But devices are a little bit more complicated, and so I'm wondering, what are the common elements because I suspect that every label already has those pieces. They just have to make sure that it gets in the right place.

MS. WEICK-BRADY: And we're looking to ask the public what would be those common elements, what are the things that you would want to see in a labeling repository.

MS. ITANI: Actually, device labeling does not have common elements. If you look at existing labeling, labeling that's been out there for 20 years versus labeling that is now being issued, there are older devices, right or wrong, but there are older devices that do not have the indications for use on the label today. They don't necessarily have consistently sections on warning, precautions, et cetera.

it is a very, very diverse field, and I think, before labeling for drugs was converted to electronic format, there was a lot of effort, first, to create the common format. Today, that does not exist for devices, actually.

DR. NELSON: But I suspect that every device, or pretty much every device, has an instructions for use, something about care and maintenance, something about how you use it. No?

UNIDENTIFIED SPEAKER: Mention has been made about format and the drug information is in XML, specifically SPL. What is the format being considered or some of the formats being considered by CDRH?

MS. WEICK-BRADY: The pilot that we're working on right now is taking XML and moving it into structured product labeling, or SPL, and seeing how that works and seeing what codes are there that already exist and then what codes would need to be developed.

MS. SHRADER: Could I just -- I'm Pat Shrader with Medtronic -- respond to the question about instructions for use?

I think one of the very informative presentations that FDA did this morning pointed out the fact that for devices whose use is well known, there isn't a requirement for instructions for use; they're actually exempt. And if you think about the universe of devices, you know, there's no instructions for use for my glasses. There aren't instructions for use for band-aids. There actually are not instructions for use for things like needles and syringes.

So, you know, one of the questions that has to be considered here is for products for which there are not instructions for use or warnings and limitations. Are they going to be exempted from this repository, or would it be necessary to develop some kind of labeling or patient or healthcare provider highlights so that they would be a part of that repository as well?

DR. NELSON: I might comment that what I see in the drug labeling is that the structured product label for drugs is an XML document with link codes for the various pieces of that document. Many labels do not have -- I don't think there's any particular piece of that labeling that is mandatory that that particular piece be filled in. It's just that these are the common elements, and where appropriate, it's expected that the information that's appropriate gets put into the correct place.

MS. WHITAKER: Hello, this is Lynnette Whitaker with Biomet. Just a question on what was in the presentation earlier. It was put up there that there may be a requirement for non -- I should say clear devices, devices that don't go through the clearance process. Just a comment on that, in that in our industry, there can be tens of thousands of instruments that are Class I exempt instruments, and the burden for putting those in and maintaining those is really astronomical for us, so just that comment.

And perhaps a question. Is that part of the statutory requirements, to be able to include those non-cleared devices?

MS. WEICK-BRADY: The statutory requirement says that through the registration portion, that we can request labels and package inserts of medical devices, so it's very broad. But I appreciate your feedback on the Class I exempt devices and the many thousands that you have. That's very important to know, so thank you.

MR. BLOMBERG: Peter Blomberg from St. Jude Medical.

As I have listened to the presentations -- this is my first exposure to this activity -- the first thing that struck me was why don't we piggyback this right on top of the UDI database rather than have a link?

I understand there are limitations. Many devices won't have a UDI, so I'm not sure I would play that game, but I just want to throw it out there because if we're developing an infrastructure around UDI, perhaps this is just a follow-on because that, I understand, will be a key area the FDA will look for in terms of dealing with recalls or adverse events in kind of a central location for those types of issues. So that's my first point.

The second point is if we're going to have a database with all the old instructions for use or whatever it is we currently have, legacy devices are in all kinds of different levels of, perhaps, compliance of labeling or perhaps at the time they were issued there was no compliance categories. So the thought is can we just have a PDF or scan them in?

But I don't know if that's going to get you where you want to go. I think long term, you definitely want to go down the path of the XML and the SPL approach, but at least you might have something searchable in some form or fashion.

MS. WEICK-BRADY: That's good feedback. Thank you.

DR. NELSON: I have a question for Joyce and the question relates to the photographs.

And our experience with DailyMed, for one thing, was that when we got labels that had images in them -- and many of the drugs have a structural drawing or something like that in them as well as various kinds of figures -- that these were not consistent in size and scale, and so that some of them were huge images and some of them were relatively small. And then we got into trying to take pictures of what we might call generically pills, solid dose forms, shall we say, where scale for the purpose of comparison becomes very important.

Now, have you thought at all about scales on photographs because you're dealing with devices that might be micro-devices as well as mega-devices?

DR. WHANG: I think that's a good consideration, and it draws back to, in general, how prescriptive we would be about what we'd be looking for in photos, but that's certainly something to consider.

MR. ANOWI: Dan Anowi (ph.) from Georgetown University. Just a follow-up question on the database of the devices. Have you thought of any standardization of device naming and some anthologies, probably how to integrate these databases with some diseases, for example, or link any other systems out there?

DR. NELSON: I'm going to change hats. My major role at the National Library of Medicine is the terminologist. I run the medical subject headings. I built this drug vocabulary that you may have heard of called RxNorm. I'm one of the people who is in charge of the content of the Unified Medical Language System.

The device terminology for categorization of what various kinds of devices are is an open question right now. Those of us who are concerned about standards and interoperability see that there are two candidates out there right now, the UMDN, Unified Medical Device Nomenclature, and the GMD, the Global Medical Device Nomenclature. Either one of those might be suitable if it were adopted. I don't think that it's reasonable to think that anybody else should go into that business right now.

I got into RxNorm because I was going to HL7 meetings, and it was clear, from the pharmacy knowledge base providers, that they wanted a standard terminology that they could compare information. I don't see that right now, but we certainly do, for the idea of electronic health records and interoperable information, we need something at a level that's somewhat higher than a universal device identifier. You know, we need something better than the NDC code in drugs.

But where we stand right now is we would like for there to be some standard established in the United States. Whether or not it be a standard globally or not, we need a standard in the United States so that we can say yes, we're all speaking UMDN and then we can feed back to UMDN what problems there are with categories, with the way they represent things. But I see those as the big candidates right now.

MS. REED: I'm Terrie Reed, and I'm in charge of building the unique device identifier database. GMDN is the nomenclature that we are going to have as associated with UDI, at least at this point unless something really goes wrong. So I just wanted to clarify that.

DR. NELSON: The big problem is that nobody has really been able to do any evaluation of GMDN. In fact, we haven't even been able to see very much of it.

MS. EMERY: Hi, my name is Jacqueline Emery, and I'm from industry. And I just wanted to bring a comment to the discussion.

I understand that this whole thing started out with drug labeling, and it's relatively simple there. I now work for an IVD company, and I would say the problem is still relatively simple in that there is a package insert that gives instructions for use, how to reconstitute a reagent and apply it to an analyzer.

But in my prior life, I worked for medical device companies, and instructions for use is not that simple there. Instructions for use are thick books, big books, and instructions for use include everything from changing batteries to silencing alarms to changing trans settings to doing all kinds of things with a device. And this would be really quite a chore to integrate that in your system.

And the question is, as that is not used by a layperson, is that level of detail really necessary?

Thank you.

MS. WEICK-BRADY: I'm sorry, was that a comment or a question? You're asking is it necessary? Thank you.

I agree with you, we are trying to figure out the level of detail here and what we would need and what we wouldn't need, or what would people want and what they don't want on something like this, understanding the complexity.

Thank you.

MR. PIDAPAETI: Hi, my name is Rama Pidapaeti, and I'm a consultant. I work with drug companies as well as medical devices, combination products and labeling. Is that going to be -- I know that the primary mode of action -- but who would take the labeling, I guess, in this context?

MS. WEICK-BRADY: Well, with combination products, I believe that the drug portion is already going through on electronic labeling. Is that correct? Yeah, okay.

So what would happen there is we would eventually get to combination products. I think some of the combination product manufacturers have said when are devices going to catch up with us because we're already putting things in electronic, so we're doing things separately right now. We're doing one thing for devices and one thing for the drug portion; is there some way that we can start to do this all one way?

So we have received feedback from combination product manufacturers actually looking to go in this direction.


MS. WEICK-BRADY: I don't see any more hands up, but feel free to talk with us during break.

I'm looking at Joyce right now. Do you want people to come back earlier, or do you want to keep the time with the agenda?

Okay. Knowing that we can linger a little bit in conversation, Joyce has asked that even though we're getting a little bit of extra time, that we start promptly at 10:45.

Thank you for your comments.

(Off the record.)

(On the record.)

DR. NELSON: I'm Stuart Nelson from the National Library of Medicine. We're part of the National Institutes of Health, so we have a little bit different mission than the FDA. We're non-regulatory. But our mission is to provide information to the public and others about all sorts of things.

And what I'm here to talk about is DailyMed, and DailyMed sprang out of a conversation that I had with somebody from FDA at an HL7 meeting because, as you've gathered from my remarks before, I'm very much into informatics and standards and interoperability. And I was sitting there having lunch with him, and he said well, we're about to come up with these drug labels; would the library be interested in hosting them. And I'm not a librarian, but it didn't take much for me to think absolutely, we want to have these.

So what is DailyMed? DailyMed is a database of the structured product labels for medications. It supports searching by the names or by codes. And by codes, I mean either the UPC barcode -- it can take a barcode that's scanned in and return the proper label -- or an NDC. Or you can search by generic name or a brand name. And, of course, we make it publicly available. That's one of the great things about working at the world's largest medical library, is that you get to do all these things. And people actually say you work for the government and you're doing something good for me?


DR. NELSON: I like that.

We do keep an archive of the labels, so that anything that we've ever had on the DailyMed site is always available. And working at a place -- you know, DailyMed is small potatoes where I work. We have all this GenBank information, all this sequence data. We have a database of 20 million citations of the medical literature called PubMed. It supports three million searches a day. We have information for patients that gets searched between one and two million times a day. So DailyMed is small potatoes in this environment.

But because we have this public mission and orientation, we have really remarkable availability. And, you know, any of you who search PubMed know that you can type in your search terms, and in less than a second here, you've got a response back. And we're doing that three million times a day.

And we have sites that are remote so that we're not subject to the vagaries of power in one area or whatever. I don't know what happens with a big E impulse, but we'll worry about that -- we'll have other things to worry about that when the big E impulse takes place.

The other features that I put in to DailyMed were a number of different kinds of links: certainly, a link to PubMed so people can search the literature; to MedlinePlus, which is our database of patient information, to information about clinical trials.

There's another database that's produced by the library about presence of drugs in breast milk and a link to the error site for reported adverse events.

And as a terminologist, I'm very interested in standard terminology, and it looks like RxNorm is going to be the standard terminology in the United States. I put up the RxNorm names in codes on the labels by the labels themselves. What's actually in the label does not get altered by DNLM. We provide other links, but what was submitted to the FDA and sent by the FDA to us is untouched by us. We don't want to get into that business. DailyMed has some interesting functions. One of the things that people have found useful, manufacturers have found useful, is that on the homepage we have a preview site, and that preview site allows somebody to have, take a structured product label that they are getting ready to submit to the FDA and put it into the DailyMed site and look and see what it would actually like on DailyMed before they submit it, which, I think, for usability and so forth, is very helpful.

We have certain kinds of -- I think that we need to work much more on visual representation of materials. I think it's much more easily understood. So that when I go to the Drug Information Association meeting, I'm trying to tell them be more visual in your labels because you can represent information a lot better that way, and here's how you can look at it.

We also have a product identification system. We have a few hundred, maybe about 800, images of solid dose forms, but we also have the dress information: the size, color, shape of solid dose forms, so that those things could be -- the imprint data -- all those things could be used to identify what the product is.

You know, if you're out there in the emergency room and you're pumping somebody's stomach out and they have some fragment of a pill with something on it, you can at least get the color and something off the imprint maybe. You can find out what the heck it is.

We have some other functions. You can download the product labels, you can print the labels, you can e-mail them to your doctor saying see, I told you this drug caused a rash. You can search the archive for old labels, and you can set up, you can subscribe to an RSS feed and be notified of any changes.

The DailyMed started as an interagency agreement between the National Library of Medicine and the Food and Drug Administration. We started in November of 2005. We had one label. So people at the library were kidding me, you know, you've got a database of one thing. That's not a database, that's a datum base. And for about six months we were like that. And originally it was only for FDA-approved drugs. Now, what, five and a half years later, we have 22,000 labels that includes over-the-counter medications, homeopathics, unapproved drugs, veterinary drugs, a whole variety of materials are available in DailyMed.

I think that, you know, what happened was at first, the manufacturers were really kind of reluctant to submit labels, and they were a little bit afraid about how costly it was going to be and how difficult it was going to be and so forth. Once they got into it, they found out that it really did work pretty well for them.

Our use is growing steadily. We count page views, and we were up close to 11 million last month. But it's still growing like that. Eleven million in a month, well, that's okay. There are six million prescriptions written every day. So if we ever go to paperless labeling, which I've been talking about with PhRMA because they'd like to do some pilots to see about paperless labeling, if they ever go to that, this is going to explode.

One of the interesting things about it is the statistic. We're having eight minutes per page view. People are actually reading the stuff. People are actually using it.

By the way, we have certain kinds of things that we have to do. One of the things is that we have what we call 508 compliance. We must be able to support people who have various kinds of handicaps when they come on the computer to our website. So people who are visually impaired, everything there has to be available on visual to a screen reader. You know, we're sensitive about our use of colors and so forth.

And we also, just recently, developed the DailyMed mobile site so if you take your iPad, iPhone, BlackBerry, Android, whatever, and you go to DailyMed on that, the DailyMed site recognizes that you're coming from a mobile device and responds with a mobile-appropriate view of a label, which it turns out can be just quite different.

We're set up, we get a secure FTP from the FDA daily. We get about 75 to 100 labels a day. Most of them, these days, are updates, but we still get some new stuff. And, of course, a new drug that's approved, we had one a couple of months ago. The drug was approved on Monday. Monday evening it was up on DailyMed. Tuesday we made the RxNorm name for it, and Wednesday it went out on the RxNorm weekly update. So we're trying to stay current with things.

We have a short embargo period in case they say whoops, we sent you that by mistake, don't show it up. But after that, it goes up, and it's online in about two hours from when we receive it.

So having said that, for those of you who have never seen it, here's DailyMed. Let's make this bigger. I like to be able to see what I'm doing. Okay.

So you can see the functionalities here. We have the product identification system, the previewer, adverse event reporting, archives. We could actually take a request for an archive, show me everything that was available, you know, in January 2008 -- January 15th, 2008 -- and make an archive, pull it off of our files and create a large file to send to somebody. And we can e-mail information.

If you want to see a label, let's go here, and we'll type in one of my favorite drugs here, Ticlid. One of my favorite drugs because this thing is scary.

Although somebody said earlier that black box warnings are always in the same place, that is not the case. But we identify where the black box warning is and put it up so it's Number 1 on the DailyMed site. Black box warnings can be down in a precaution portion or whatever.

Now, you see here we have these sections of the labels up here from the Description, Clinical Pharmacology, Indications & Use, Contraindications, and so forth. You'll see some of them are grayed out. That's because there's no information put into that field. And that's easy enough. If there's no information, we just gray that out.

But these are what I was referring to earlier as the common elements. These are the kinds of things under which you break apart the information so that it can be processed because say, for example, I want to have the ability to search for something about a rash. Now, I can have rash under indications for use or I could have rash under adverse event, and I want to be able to separate out those two kinds of meanings. So I have that ability to search into those.

Okay, you see the RxNorm names and codes here, and sure enough, here on the left we have all these nice little links, like to be able to search PubMed, find clinical trials involving a drug, MedlinePlus information, presence in breast milk, and so forth. And you can read through all of the label. Okay.

Now, you understand why this is not on a mobile device in exactly the same format. But it's taking the same information; it's just repackaging it in a way where you can see it better on a mobile device.

So what else is there to show you? Most of us take some medications, right? We want to know about it, we go here. And you can see all the prescribing information. This has a patient package insert, which is really patient oriented information. There are also things called medication guides, which are patient oriented information. And there is currently the FDA and the Brookings Institute are working together to draw up kind of a common format for, you know, whatever you -- patient medication information, whatever a patient needs to know about their medication. Okay, let me get -- where am I here? Let me shrink it. Well, tell you what, cut to the chase.

So, to me, what I would want to see, to make a device label website, would be -- it shouldn't ever get mixed up with the drugs. I mean, yes, there are these combination products in these wonderful kits that have all sorts of things. We need some kind of common categorical names. You don't want to look up a product by, let's see, BD Lo-Dose Ultra-Fine insulin syringe. You don't want to look it up that way. Do I want to look up BD Ultra insulin syringes? Sure, why not. Do I want to look insulin syringes? Perhaps. But I don't want to look it up by the full product name necessarily because, in fact, most people don't ever get them right.

I think a structured product label needs to have those common elements in adherence to a standard. Link is very cooperative in giving codes for the structure of a structured product label. Should this look like the structured product label of a drug? No. No question about that. Do we need to get those elements defined? Absolutely.

And, lastly, if you want to build a good website, give it a catchy name so it's easily remembered. I was very gifted to think of, you know, DailyMed because it's updated daily and it's about meds, and it just like kind of came to me, and it was like yeah, that's it. But whatever.

Thanks a lot.

MS. WEICK-BRADY: Do you want to wait for questions at the end or have questions now? Okay.

We'll go ahead and take questions for Dr. Nelson.

MR. SECUNDA: Actually, as a panelist, can I take the prerogative and ask the first question?

Did you say that there were 22,000 labels on DailyMed?

DR. NELSON: I did.

MR. SECUNDA: And is that just the labels or like the dataset that you showed us?

DR. NELSON: There are 22,000 current labels.


DR. NELSON: Some of them have as many as nine older versions that are in the archives.


DR. NELSON: Okay. But that's what's current --


DR. NELSON: -- is 22,000.

MR. SECUNDA: And what percentage of the universe of drugs would you say that is, for the current drugs?

DR. NELSON: You tell me. One of the things that drives me crazy about our host today is that they don't know what's out there. There's no authoritative source of information about what's out on the market, even in drugs. And I would venture to say that what we have, for the prescription drugs, we have essentially almost all the brand names, very few exceptions to that. Many of the generic name manufacturers, we do not have labels from them.

Although if you look at, you know, something -- propranolol. How many manufacturers, how many labelers of propranolol are there, maybe 40. How different are those labels? Essentially, in the important content, other than the appearance, the manufacturer and so forth, there's very little difference in those labels. But, you know, over-the-counters, God only knows. And, you know, we have done homeopathics and so forth. I think the vet drugs we're pretty good at.

MS. ITANI: Hi. Thank you very much for your demonstration. It's really interesting.

MS. WEICK-BRADY: I'm going to interrupt real quick. If you could just say your name and where you're from for our transcription person.

MS. ITANI: Okay. Tamima Itani with Boston Scientific, thank you.

Just wanted to ask, how was this effort originally funded, how much did it cost, and then on an ongoing basis, what is the maintenance cost, who pays for that, and are the drug companies required to pay to actually get their labels, and if you could please address that aspect?

DR. NELSON: No. Unlike the PDR, we don't charge the manufacturers.

How much did it cost? It cost amazingly little to build the DailyMed site. The Agency for Healthcare Research and Quality did give funding to the Food and Drug Administration to develop the tooling for handling an electronic structured product label, which was really a very remarkable step. What the FDA had to do was huge. What we had to do is relatively small.

I actually support this site with one and a half FTE, okay, and the overhead on servers and so forth is just not that great, so I don't know, what, maybe, you know, quarter of a million dollars. It's small numbers, you know, when you look at it.

Okay. Anyone else?

DR. WHANG: What is the availability of photographs?

DR. NELSON: Pardon?

DR. WHANG: What is the availability of photographs?

DR. NELSON: Well, we have about 800 photographs in the product identification system. Okay.

I can show you, also, here another favorite medication, right? And we also put them up at the DailyMed site so you can see. And this is, come to the thumbnail and we click on it, get a larger image. So we have about 800 of those right now. I would kiss the feet of anybody who could supply me with all of them, whatever all is, because this is where the real challenge is, is that we don't know what all is. I'm not sure that we know all devices, but -- you know?


DR. STORY: To be 508 compliant, do you also verbally describe the image?

DR. NELSON: I think we just say that it's a picture of it, okay. You know, 508 compliance is a lot like sexual harassment. You don't know what it is. You can't define it, you know? It's really hard to know. I mean, as a manager, I get to take these courses, sexual harassment; I say well, what can't I do and what can I do? They can't give you a legal definition. And the same is true with 508 compliance. We don't know. We always try to be as descriptive as we can be.

MR. OBRADOVICH: Yes, hi. My name is Dragan Obradovich with industry.

They do describe the tablet, the capsule, and the data elements of the SPL file, so it's in there as a descriptor. It tells you if it's oval shape, what color it is, and all that kind of good stuff. So it's in the data elements but not necessarily with the image.

The other question I had is we talked about updating, submitting these files on the annual basis when it comes time for establishment of registration and listings. One of the issues that we dealt with on the drug side was -- well, one of the issues we have on the drug side is we're required to submit every time we have an approved label, we have to submit within 14 days of that approval through the eList system which then populates DailyMed. Is that something that's going to be considered? Because the flip side of that is if we do it on an annual basis, you have a lot of devices, a lot of listings, is the expectation to have them all listed in that first year in this manner?

MS. WEICK-BRADY: I guess I'll answer that.

DR. NELSON: I'm not the FDA, so I can't say about expectation. But I can tell you that, although they told me that by, you know, open up the site at November 2005, that by November 2006 I would have them all, I'm still not sure I do, and I only had maybe a thousand by November 2006.

You know, tuning up for these things requires a lot of work on everybody's part. I think the result that, you know, for patient safety, this information is now available, current. How many times do you think a prescriber sees a piece of paper that's folded up inside a box and sitting on a pharmacy shelf, you know? They don't see it.

So the fact that it's there and making it available, I think, does a great deal for patient safety and also product liability, reduces product liability because now the label says these are the things that you need to know. And, you know, it may not even be in an old insert that's sitting in something that you get from the pharmacy.

MS. WEICK-BRADY: I think, to respond to your question on the device side, I believe it would be a phased approach. It would have to be for both FDA and industry side because asking for tens of thousands of labels in the annual registration listing process could be daunting for everybody, at best, so I would envision a phased approach to this.

DR. NELSON: Going once.

MR. SECUNDA: Just a comment.

And the reason I asked about the 22,000 labels and also a comment to a phased approach, devices, 22,000 is one company and many companies have hundreds of thousands of products and labels that would have to be submitted, so I think it's important to keep that perspective. Quite frankly, I think the DailyMed is fabulous and it makes so much sense in terms of the availability, the information, and the need for the information and the usefulness of the information that's in there. I don't want to get into my talk, but you know, devices are just a universe away.

DR. NELSON: Right. And I think one of the things that needs to be addressed here is what information should be available and needs to be available. And as far as the size is concerned, I mean, I support a database of 20 million citations. You know, 22,000 labels, 50,000 labels, 100,000 labels, that's not a big problem.

I forget how many base pair sequences we have in GenBank, but it's astronomical, you know. We're used to dealing with large datasets, so I'm not terribly concerned about that. What I would be concerned about is trying to make sure that the information you provide is the information that needs to be provided.

MS. WEICK-BRADY: Aaron Moskowitz is breathing behind you, so I think we'll --

DR. NELSON: Great.

MR. MOSKOWITZ: I'm Aaron Moskowitz from the Biomedical Research and Education Foundation. I'd like to thank the FDA for having this meeting and for inviting me to present and speak to a few things, including the healthcare provider perspective and some of the things that I've been hearing.

A little bit about our organization. We're a nonprofit, been around since 2003, located in Philadelphia. We have a very supportive -- a diverse number of people on our board from medical associations, private doctors, some business people as well. We host conferences; we do a lot of research, unfunded research; we do publications for primary care doctors as well as patients; and one of the other activities we do is we're a listed patient safety organization as recognized by HRQ, been doing the last couple of years with them. And one of the primary activities that we do is the website. And I'll be talking about that as well, in the presentation.

A little bit about the scope of what I'll be talking about. I spoke to a lot of doctors over the years about their concern with medical devices and just sort of what's motivated a lot of our activities. And I'll review some of those things, go over some of the information sources available to them and the public at large when they have these questions: where do they go; what that process is like; what we're doing about it, which is our website,; and some suggestions for the group at FDA and industry and probably ourselves as we move forward and where there's some room for improvement.

One of the number one problems that we've heard and that we try to tackle with the registry is what does my patient have. Patients often lose this information. They don't know exactly the device that's even implanted in them or even the devices that they have at home. This makes it difficult for doctors to find information about that device. Our registry allows patients to keep online records of that, that they could share with the healthcare provider.

And then, you know, all these questions, what's my device, turn into other discussions: can I receive an MRI or a CT; will it interfere or have -- interfere with the image outcome; concerns about their prescription drugs; news about recalls -- you know, number one way people hear about these recalls is through the popular media, and they'll go back to their primary care doctor and ask questions. You know, this is often a quicker release method than the current system where the doctor gets notice and contacts their patient.

And then, we also want to be able to direct patients to the right information. Again, they'll see there's a lot of information on the Internet, you know, where can you find what's relevant to you.

So finding information about devices is difficult, to say the least. I'm sure that's why we're here. And one of the things that people want to ask about is, you know, imaging compatibility, drug interactions, and then how can they troubleshoot problems that they have with their devices. And so this is sort of where we are.

Okay, this is another important thing. So why are these images important? I know we've talked about a little bit is why do doctors want to see images? Certainly they want to identify the non-planted devices. Something comes in and they want to identify it, maybe there's a name on it, can they look at an image? Hopefully, if there's a current version of the device, current model, they'd be able to do that and check it across the website.

And this is important for a lot of reasons because identifying the right device is more difficult than just knowing the name of the device. You need to know a lot of information about the model number, specifically, to get what you're really looking for.

One of the other things for implants, knowing what the device looks like when you receive a medical image back from a diagnostic radiology group is often helpful. There is a way to look that up at -- and besides just the device, also the -- showing anatomy, if it's normal or abnormal. I think one of the current things that was in the news was the LAP-BANDs, and that's something that I've heard from doctors before, is not knowing what they're actually looking at. So it's, you know, just a for instance.

So current sources of information, you could ask somebody else, you could go to Google. If you don't want a primary care physician to see it, just publish it because they're pretty much buried in an article. So those are the information sources. Then there's also the information specific to the patient, you know; there's the healthcare record that the patient has, sort of individualized information sources that help any healthcare provider make conclusions and talk to their patient.

So I wanted to do a little quick demonstration on information gathering on devices, so I picked two somewhat popular devices, a spinal implant and a home use device. First step was to determine the name of the device I was looking for because a little trickier than it might sound. And then I looked through the expected sources: the manufacturer sites, FDA sites, Google and other search engines.

So one of the first things I look at is that implanted device, CD Horizon's spinal fixation device has been around for years through various iterations. You could see there's a lot of reports on it. There's a lot of MedSun reports.

One of the things to look at, though, is the number of approval numbers. Just looking at these approval numbers doesn't tell you too much about what the device actually is. There's a lot of associated devices, so just looking in the FDA's database for a CD Horizon by Medtronic doesn't tell you, you know, that's not the device. There's a lot of associated devices with just the name. So the unique device identifier would be important.

Using images to help verify what you're looking for will be important. There needs to be some work on this before we can really make meaningful links between, you know, these other reporting databases, the adverse event and MedSun. So if you go to the manufacturer's website, there aren't pictures. You know, this is just one example. If you go to another website, there are images for different manufacturers, but for this one, you actually have to go to another site that they have, that Medtronic has, to see what you're looking for, which is that spinal fixation system. And it's just the current version that they have information about. It doesn't really have an FAQ except for if you're looking into getting a procedure.

And the way that some of these sites are organized are through procedures and disease states. They're not necessarily organized around device classes, so the way that these things are categorized is a little difficult as well.

Here's a more popular device, a glucose meter. Tons of reports coming in, there's a lot. And you have to be very specific because Accu-Chek
-- is just news for so many associated devices as well, so you have to use some common sense with what you're looking for. Again, it has a large number of different approval numbers associated with.

The manufacturer's site has a lot more information, including trouble shooting, photographs of the device, very helpful information for the day-to-day user.

And then the other places you go for information, there's a lot of places that sell this device online in various inclinations as well, and prices. And they have images. They have customer reviews. There's a lot out there. And, again, trying to link this information back to that, say that 510(k) number isn't a one-step process. It's something that you have to think about and bring a lot of that information together.

So move along a bit. So one of the things that I notice right away is that the current information out there on the FDA, its databases aren't linked. There's all the access data, there's the portal there, but all the information is disparate, and connecting those needs to be done, especially if we're going to start collecting more information like labeling. That's one of the steps that we brought in.

Even in those data fields there's absent fields. It's one of those other things that complicates the system. Just knowing the name and the manufacturer aren't enough to verify a device for what you're interested in or looking for. And, of course, right now, obviously there's no labeling or images, one of the things we're discussing today.

A unique identifier is hugely helpful as well as just common naming of devices. Finding a single site or way of organizing this information across various resources that a primary care physician has available. Images as well -- both photographs, radiographic images, anatomy, these are the things that I've heard would be of interest to primary care physicians, the contraindications, and then also a resource list; what are the links that you want to go to?

Instead of searching around the Internet blindly, it would be great if there was "this is the direct link to this device that the manufacturer has up, that the FDA has up." There are other user groups. We could help bring all this together.

So one of the things that we started a couple of years ago was work with Medical Device Registry. This is an online website. It's a free service. You can create an account. You could still use it without an account as well, to just look up specific devices. You have to know what you're looking for, but you could find it there. You talked about the number of devices. We have over 140,000 devices logged in to our system. And that's just approved devices and devices that have been cleared for marketing by the FDA.

So it's really designed around consumers and users. You could register your devices. We'll keep a record of that. You can share that information with your primary care doctor. And then we bring in as many links as we can, associate with that specific device. So, again, that's the recall information, all of the other access data -- as well as external links for manufacturers, news stories.

And one of the things -- so here's an example screen shot. I don't know if you could really read what's involved here, but I wanted to point out a few things. So here is a catheter. You'll see down here other trade names, and there's all these other devices given different names that have the same approval number. You know, these databases are messy, but we want them together, try to organize it into a meaningful way.

Then we have, what we call, large -- really, reports what they would call them, from the different databases. We have some date ranges on that. So just some basic information on -- and this is an example user. We just registered this one device. This is his device that he has and wants to find information about. But you could go ahead, and if you clicked on the name, you'd be able to find the actual page for that device, which I think was the next example. Or it's actually, here's some more.

So here's an FDA recall, it comes up in red, if there's been a device -- right now, we're just looking at the Class I recalls. We're going to be trying to link in the last two recalls soon. But, again, whenever you bring in these databases, you have to link it meaningfully to the right devices, which is part of the challenge here.

So this is sort of the site from a user's perspective. I guess if you can see this up here, you have links to device profiles, so you can look at just the device profile if you don't have an account logged in. You have your profile, your devices, and this is -- when I say your profile, the only thing that's required is an e-mail address to sign in and a password through an SSL. And then other information that you want to put in is for your own use.

You can register other devices that aren't in our database. They sort of sit idly unless I can connect them to an approved device. But if there's something else you wanted to include and keep track of, you can certainly register that in. If it becomes available later, then we can link it back in.

So the final suggestion is there needs to be a good way to link this information together. If we're talking about bringing in images, you know, we got to know if it's to which model, if it's current, all these little pieces of information need to be linked correctly to the right device. Images are useful, both of the device -- and if it's an implanted device, surrounding anatomy. Labeling and user manuals are things that people are looking for. We already know you can buy these -- or a lot of devices online and people are looking for more information about them. You know, if you buy a second-hand device or a used device or you get one, you'll probably also look for it on the Internet.

Contraindications for imaging and for other procedures, legacy devices, and a version tracker would be helpful. This is again one of the problems you run into when you try to link the devices. There's an immediate way to update what you're looking for. And then even just a simple list of online resources would be helpful. You know, this is -- the Internet is a big place, and it takes a lot of time to find out what you're actually looking for.

I'll take some questions now.

MS. WEICK-BRADY: I'm going to take advantage of being on the panel and ask you a couple of questions.

I would just note that probably valid online resources versus just online resources, but one of the things that you had talked about when you were looking up the glucose meter, you went to the FDA site, you went to the manufacturing site, and you saw good troubleshooting FAQs and other information. Then you went to another external site where they were selling the product. Were the FAQs and the troubleshooting information, anything else there, was it the same as the manufacturer's or was it different? I'd be very concerned if it was different. I don't know if you remember, but --

MR. MOSKOWITZ: Yes. So some of the information -- so I was just looking for that -- I think for that device, I was looking at some online retailers and, you know, consumers talk to each other through these comment sections as well, and that's probably not the best place to get the FAQs.

So there are problems that people post up there and then people talk to each other in the comment sections. That's probably not the best place to get your answers from. Although it might be, you know, talking to fellow users is certainly a powerful tool for a lot of other activities, so that's something to consider as well.

MS. WEICK-BRADY: But I guess I was thinking with troubleshooting, and the manufacturer had put that up there on purpose to help their consumers and then troubleshooting on a distributor's website or a seller's website, would that information have looked the same?

MR. MOSKOWITZ: No, it didn't. Not from what I saw. But -- yeah.

So that's just one example, and if you look at that, there's actually a lot of tabs on their site for how to use this device and FAQ and other resources, so -- I was just trying to show that there's a wide variety of what manufacturers provide to users.

DR. NELSON: Would a device, as a report or a recall on it, do you send out mail to the registered users?

MR. MOSKOWITZ: Yes. We'll send you an e-mail if you --

DR. NELSON: So you are storing personal information?

MR. MOSKOWITZ: Only what they provide. So right now, the only thing you need to provide is an e-mail, and that's just to log in to the site. It's a verification.

So, again, we don't know how to verify authenticity of users. That's one of the things that I want to differentiate. You know, even though we call this the Medical Device Registry, a lot of people think it's a way to discover new events, but it's not validated in any meaningful way, so it's a user-driven website.

DR. NELSON: And your list of online sources, what do you do about the disappearing URLs? You know, this has been a problem at the library that we've had to face because something like 40 percent of URLs disappear within two years.


DR. NELSON: Do you have a spider that crawls -- what we do in MedlinePlus is we have a spider that crawls in every day to make sure they're still up.

MR. MOSKOWITZ: That's a good suggestion. We'll have to look into that. And I suppose we could look at that and back in and find the dead links and then remove them. Right now, it's just a struggle to find this information and get it up there, so -- because there's -- you know, like I said there's just FDA approved databases. There's over 140,000 approved devices, trying to find relevant links for each one of them. You know, it's a feat in itself, so we'll worry about taking the dead ones down next, but --

MS. MERITZ: My name is Judy Meritz with Covidian.

The same question that was raised before about funding, how is this funded?

MR. MOSKOWITZ: Right. So right now, we're privately funded through philanthropic grants and through individual foundations. We've been doing this for -- since 2003. And so the funding depends on the projects that we're doing each year. We received funding specifically for this project from other foundations and individuals. We've received no manufacturer funding and no government grants.

MS. GEORGE: Elizabeth George from Philips Healthcare.

The question I have is, is who does all the populating and the decision making of what gets put on that site and how is it validated, that it's, in fact, accurate?

MR. MOSKOWITZ: Right. So this is a good question.

You're looking at him and we do -- so some of the process is automated. The FDA sites are checked weekly and then updated. So I think -- on an ongoing basis, too. So we have several databases on the back end.

It's really interesting if you try validating some of this information, which we do regularly. If you look at -- and this is just sort of how the data comes in and search logic. If you try to search and do a one-by-one comparison, you find discrepancies, and we've done a lot of work in trying to find out why that the data downloads aren't the same as if you go to the access data website and run a search. Part of that, I guess, is you have to know exactly what you're searching for.

So some of these questions and user experience are pretty important if you want to find exactly the right answer. So, again, this is something that we manage internally. We try to keep sanity checks on the information, making sure that it's correct, to the best that we can. So this is ongoing. It's an ongoing maintenance issue, is validating the information that we present.

MR. BURKE: Hi, my name is Michael Burke from RTI International.

Since you're providing the provider perspective, could you briefly comment on off-label usage?

MR. MOSKOWITZ: So, actually, I don't have anything to add on that other than I have -- you know, I know that for some devices that occurs, but that's not one of the things that I reflect into.

MR. BURKE: That's nothing that providers necessarily are looking for, to know whether a device has a common off-label usage such as for pediatrics?

MR. MOSKOWITZ: No. I haven't heard that, but I'm sure that they are searching the Internet for that information. From the doctors I talked to, nobody said I can't find a good site to recommend off-label use. I don't know, so -- that's a great question, I mean. It's probably something people are looking at and looking for, but we don't collect that, and I don't know where to find it, so -- all right, thank you.

MR. SECUNDA: Okay, good morning. Jeff Secunda. I'm the Vice President of Technology and Regulatory Affairs at AdvaMed, which is the Advanced Medical Technology Association.

And just to let you know that AdvaMed is the largest trade association representing the medical device industry. And our members are manufacturers of medical devices, diagnostic products, and healthcare information systems.

I'm very pleased that FDA has invited me, on behalf of AdvaMed, to address the industry perspective on the consideration of an online repository of device labeling and photographs. Industry is committed to working with FDA, patients, and care providers to understand the device information needs of the public. We also want the stakeholders to understand the nature of device labeling information. Most importantly, we want to ensure that device information is appropriate, correct, and, when necessary, accompanied by associated training.

So, by appropriate, this refers to the device information that is appropriate for the situation. Reprogramming information for a narcotic infusion pump clearly is not appropriate for all those who may seek the information. Setup information for complex devices may only be appropriate for those with a clinical background.

Correct information may seem obvious, but finding the correct information for a device can be a daunting challenge for those who are not familiar with the width and breadth of different devices, models, and versions.

Training for many devices, whether for a patient or professionals, is often critical for the safe and effective use of devices. Labeling without appropriate training can lead to hazardous situations. And I would say that, as mentioned earlier, training is not the best way or, that is, by itself, the only way to teach people the overall practice of using a device. On the flip side, the labeling information that may be in the instructions for use or even in a quick guide is not necessarily designed to provide all the information that the patient needs. There are often scenarios that have to be worked through. It's not just, you know, one step, two steps, three steps, but a complex process of putting things together and that the training is not just something to help the labeling; rather the labeling is something that helps the training.

Okay, I also wanted to mention a couple of points of law, and over-the-counter devices and prescription devices intended for home use are to be accompanied by paper labeling, so there's not an option there for these devices that are the ones that patients are using themselves must have the labeling that describes the use of the device, the safe and effective use of the device.

The other factor is, is that some labeling -- or rather, some devices are allowed to print, that is to say, distribute their labeling solely in electronic form, that is, on CDs, and this is often used by extremely complex devices that may have hundreds, if not multiple volumes, of instructions for use. However, the manufacturer does have to provide the actual paper copy, and however many volumes it is, if requested by the healthcare provider. Okay, in light of the presentation on DailyMed, I wanted to point out some of the significant differences -- although some of them had been pointed out -- between drugs and devices, and that we should be careful in our consideration before adopting a DailyMed-like solution for devices.

First is the vast variety and complexity of devices compared to drugs. Now, the drugs, themselves, are quite complex, but as was mentioned, there's a limited number of forms, a limited number of routes of administration that make this fairly achievable in describing, on an online database or in literature itself, in the paper material itself, what is necessary for the safe use of the drug.

You know, the question that I asked earlier about there are 20,000 labels in the DailyMed, that's a very large number. It's a very significant number. It apparently is a large percentage, at least, of the prescription drugs, and that's marvelous. You have a complete dataset there. With devices, you don't have the format that you can achieve within drugs. You have big devices, small devices, complex devices, devices that are used once and thrown out, devices that are used for 20 years at a time. And the formatting of device information in an online database is a different procedure all together.

So I also wanted to touch on the differences in the roles of the healthcare team. Now, these are generalities, but for the most part, drugs are prescribed by physicians and administered by physicians. They don't use them unless they're the patient as well. Nurses are involved primarily with administration. Some nurses are certified to do some prescribing. Pharmacists are another member of that team, and they're limited to dispensing and counseling, conveying certain information about the drugs. Devices, on the other hand, you have physicians that are prescribing the device, using the device, and involved in the training, in the safe use of the device. Nurses are using and training. Laboratory technicians, another category, are using and maintaining devices. And the home care provider is intimately involved with the using of the device and, very often, the training or hopefully in the training as well.

So we have the device/user interaction. So the professional user -- let's take, for instance, a surgical laser. As a professional use device, it's only in the hands of the professional. The patient, hopefully, is deriving benefit from the use of that device, but they have no real connection with the device as to how it is used safely and effectively.

The professional patient use is yet a separate situation where, you know, going back to our PCA pump, our narcotic pump, the professional is there to program the device, what is the total dose that the patient can receive over how much time, how big is each individual dose, and then the patient is involved because they're actually pushing the button and following the program prescription that the professional put in there. They're actually administering the drug, themselves.

Patient use, and this would be in the category of common devices that, perhaps -- a blood glucose monitor has been mentioned before. There is some training in the beginning, but the patient is on their own in the use of the device. And then there's the care provider and the patient use. So this could be either where you have a home care provider or a family care provider. and there's a different level of understanding of the device, their background, and their ability to get additional information.

So this is a photo, obviously, of many different photos, and the range that I have here is we have this tiny little MRI device, which, if you've ever had an MRI -- the thing that impressed me the most about the MRI wasn't its size because there's lots of big devices; it was the noise. And I know that there's work being done to try and modify that, but this is an enormous device and this isn't even the whole thing. This is just the magnet and the ring and the table. You don't see, you know, the power supply, the computer, maybe the helium storage tanks. It's just enormous.

And so we can imagine this is perhaps not the most important device to have a picture of on an online database. On the other extreme, over here, these are coronary stents. I think you can see that. But even here, the value of a picture there, it's very interesting. It's kind of neat to see how tiny they are. But, again, it's unclear to me where the benefit would be in having a photograph of a stent online.

I guess we'll go over here. This is a very important home care device. This is a hemodialysis system, and those are all blood lines that are going from the machine to the patient and back. This is a very critical device, and whether it's identifying the device by looking at a picture of it or for that matter accessing a quick setup guide in labeling is probably not appropriate. And then, down below, we have an implant. This is -- actually, I'm not even sure if it's a pacemaker or an implantable cardiac defibrillator. But, nevertheless, it's implantable and it does communicate with the outside world when interrogated by the appropriate device and so -- I mean, this would be the professional side of it. This is the patient side of it. So, again, who is going to use the information and who is it relevant for.

And then, finally, over here -- and one of our commenters in the public mentioned the eyeglasses -- these are all medical devices. And having online labeling for the use of these devices or even a picture of the devices is something that is really unclear to me.

So just to summarize this section on the photographs, we have to look at identifying the need for the photograph. Is this just something that's interesting? You can certainly go to Google Image and get lots of -- well, full disclosure. That's where I got all those pictures from.


MR. SECUNDA: Or is this something that is actually going to get used? Now, in drugs, I think that's a very critical issue is having those images, especially in the solid dose forms because, you know, they all look the same and whether it's you go on vacation, you say oh, I only need five of these pills and five of these pills and you put them in a baggie, and oh man, which one is which? I mean, there's an important benefit there. So identifying the need for photographs is really critical.

And then, as we've discussed, recognize the differences between the information needs of drugs and devices. And the third is the risk of misidentification. With drugs, it really is a flip side. You have a huge risk of misidentification without the image. With devices, you have a potential for misidentification because the picture of the device does not convey, really, what the device is, who manufactured it, what model is it, what are the precautions for this particular device as opposed to this one that looks just like it but it's really not discernible in a picture.

So let's consider where this information comes from. We all want to get access to the information. Hopefully, you're going to the source of the information, that is, the manufacturer. They're responsible for the device, whether it's the design, the manufacturing, the appropriate distribution and marketing of the device. They're also fully responsible for the content of the labeling.

So if you're looking for information on the device, the manufacturer is where it comes from. Hospitals use information from manufacturers to do their user training. Whether it's patient training or in-service training for staff, they're going to the manufacturer for that information.

Home care providers, same thing. They might get some additional information from clinicians at hospitals that they work with, but for the most part, that information comes from the manufacturer.

And the device supplier, who is in this category. I mean literally the people that just drop off the equipment. They're not engaged with the patient. They certainly are going to the manufacturer for the information. So in considering the accessibility versus the usefulness of information, I think this is probably the key point to consider. Just because you have access to information doesn't mean that it's the appropriate information for your use or that it's the correct information for your use. And probably most important is that correct information and being able to find it. We've heard a number of speakers that talked about getting the information and that getting that incorrect information is something that is adding risk to the system.

Adequate training is a very important factor. Not all devices need hands-on training, but many of them do, and devices that require that training are going to potentially be misused or used incorrectly without that training if one relies solely on the labeling.

So the manufacturer ensures that there's the usefulness of the accessed labeling and the manufacturer continues to assist in the information gathering by either a 1-800 number, through customer service, where people are trained to deal with the public who are looking for information, they know the products, they know the use of the products, and they are going to be able to direct people to the right information for the right purposes. Manufacturer websites, depending on the product, are also very sophisticated, some of them being set up in the model of a rational questionnaire where there's a series of questions that are asked the online person and they are guided to the correct information that they're looking for or, if not, then to a real person that can ask questions and get them to the right information.

So, in closing, I think we really have to identify the problem. What is missing out there that an online repository of labeling is going to solve? We have to be absolute vigilant that in doing any solution, that we're not introducing new risks that did not exist before. And we cannot forget the associated interactive training that is an essential component of the safe and effective use of devices.

And the burden to the healthcare system, we understand that FDA is gathering information on what that could be, but the burden is also on FDA for collecting the information, for maintaining the information as well as on industry for rewriting, essentially, labeling information in a structured format, and this is particularly burdensome when the need has not been clearly identified.

So I hope that we will be able to continue this discussion in a very deliberate fashion, and I think, clearly, this public meeting is exactly what we are looking for so that we get to hear from the people that are needing this information as well as the industry who's providing the information and all the other stakeholders. So thank you very much.


MR. LEAHEY: Again, Mark Leahey with the Medical Device Manufacturers Association.

Jeff, thanks very much for the presentation. I think you did a great job articulating many of the issues here. I'll just make two brief comments, and this will actually eliminate the need for me making a comment in the afternoon, se we'll move things along.

One, I want to reiterate the identifying the needs. Certainly, I think there have been some examples brought up. Perhaps those devices in home use where there clearly are issues that FDA has seen in which something like this with more information, accessible to the patient, would address the issue.

But I think it is important to focus on a targeted solution to those specific instances versus creating an entire new database that may or may not have benefit because again, I think, given the budgetary issues we've all discussed and we all recognize right now, creating this -- a new database that may have benefit in small, targeted populations, I think, is not a good and efficient allocation of resources.

And I think you would be hard pressed -- kudos to the gentlemen up there. I think on average, one and a quarter FTEs running those two websites, I think FDA would probably have to allocate additional resources to -- than one and a half or one and a quarter FTEs.

The second point I want to make is, again, let's not try to reinvent the wheel here. I think, in relation to providers, access to information, we've talked to many physician groups out there. I've never heard any of them talk about enhanced labeling would improve their ability to deliver care. I think there are websites out there or institutions like ECRI and others that provide meaningful information to the provider community. So I think, again, unless there are other providers here that are going to speak up, I'm not suggesting there's not a need there, but I just haven't heard from them. Related to the consumer and the patient side, again, it appears there are areas where we can do better. I think the industry wants to do better. It's just defining that scope and that universe to work within given the complexities and really the significant differences between the drug and the device industry.

So thank you.

MR. SECUNDA: Everybody's waiting for lunch.

MS. WEICK-BRADY: Feel free to grab Jeff at lunchtime, too, to ask him questions. I hope that's okay.


MS. WEICK-BRADY: Thank you. And lunch is available for purchase right outside this room. There are places to sit both inside and outside. And we will resume at one o'clock promptly. Thank you.

(Whereupon, at 12:00 p.m. a lunch recess was taken.)


(1:00 p.m.)

MS. WEICK-BRADY: And the federal government is still employed as of this afternoon, so we're going to continue with this meeting.


MS. WEICK-BRADY: And I'd like to introduce Lisa Winstel, who will explain who she is and where she's from.

MS. WINSTEL: Good afternoon. Wow, the crowd got smaller after lunch.

Okay, my name is Lisa Winstel. I'm the Chief Operating Officer with the National Family Caregivers Association, and I am the odd person out in this room. I don't have any of the medical knowledge or experience that any of you have, but I am here to speak on behalf of the 65.7 million family caregivers in our country.

So who are family caregivers? Family caregivers are people who provide essential but unpaid assistance to a loved one with a chronic illness and/or disability and also those who are suffering from the frailties of old age. The keyword here is unpaid.

So family, I want to be very clear here, simply describes a special or emotional bond with the care recipient. This bond can be based on birth, it can be based on adoption, marriage, or any other sort of declared commitment. You can be a family caregiver for your neighbor, if that is somebody with whom you feel a close emotional bond. Family does not mean specifically a blood or spousal relationship. We just haven't come up with a better word yet than family. I'm open to suggestions.

Caregiver is actually the job description, and that means providing personal care. And I'm going to be talking about this, and I'm sorry you just ate lunch, but we're talking about some very personal care that's going to be carried out. This includes medical procedures, things where, if you don't know that family caregivers do this already, you'll be surprised to find out, like oh, no, no, no, no, that procedure can only be done by a nurse. That procedure can only be done in a hospital. No, it gets done at home, and it gets done at home a lot by people who have not been trained to do it.

As I said, there are 65.7 million people who are providing these services. That's nearly one-third the adult population in the U.S. The typical average family caregiver is standing right before you, female, 48 years of age -- I admit to it -- and taking care of two or more people. I happen to represent something that's called the sandwich family caregiver generation because I get it coming and going. I have children at home, and I have parents living up in Frederick, Maryland, and for some reason they keep wanting to go to Baltimore for all of their healthcare, so I am driving all over the place taking care of everybody.

Eighty-six percent of all family caregivers provide care for a relative. The reverse there shows how many people are providing care for someone to whom they're not related. Those are those friends who are family caregivers. Thirty-six percent are taking care of a parent. Seventy percent are taking care of someone who is 50 or older.

So what we're looking at here is, while we have all been hearing about the silver tsunami, about how the aging baby boomer population is really going to grow our aging population and those needs, we are still looking at a large number of people who are not taking care of seniors. They're still providing care in the home for people and patients who are not senior citizens yet. We have 14 percent of family caregivers taking care of young adults and 14 percent taking care of children under the age of 18. Now, that is not parenting; those are children with special needs.

So what do family caregivers do? They do ADLs; they take care of the activities of daily living. This includes transfers; they're helping their loved ones get in and out of beds and chairs. Well, in the case of one family caregiver I know, she's this big and her husband, who has MS, is this big and she does all of the transfers without a lift. They help their loved ones get dressed, bathed, and shower, get to and from the toilet, and assist in the toileting process in the meantime.

Ladies and gentlemen, we're talking about 65.7 million people, many of whom -- there are 15.4 million family caregivers of loved ones with Alzheimer's disease, and in the advanced stages of Alzheimer's, those family caregivers are wiping their parents' bottoms. They help with feeding, and they deal with incontinence and changing adult diapers.

Family caregivers perform medical procedures. They do wound care. They clear a trach. They cath. They give injections. And those things are things that home health aides are not allowed to do because it has to be a nurse. No, it can be a family caregiver with no training. They do medication management. They play a very serious role in medication management. Family caregivers with no training will take and report vital signs. They will gather and report diabetes numbers.

On top of all of this, family caregivers also provide all care coordination. This is no small thing, especially since there is a field of care coordinators who get paid to do it, but very few people can actually afford to hire someone. So family caregivers communicate with healthcare professionals. They manage all of the appointments. They coordinate all of the schedules.

They manage transitions of care. This is not just discharge planning. Think of a transition of care of literally the transition from any one setting to any other setting. Transitions of care, I'm going to talk about for a minute here, are one of the most stressful moments for a family caregiver.

We advocate for our family caregivers to start discharge planning the instant their loved one is admitted into a hospital. That's when discharge planning really needs to start. Unfortunately, the hospitals and the medical situation don't always allow for that much time and sometimes it's, oh, didn't we tell you, your mom's going to the nursing home this afternoon. They should be picking her up at three o'clock. And it's the first you've heard of it. Or we're sending your dad home with you, and here's all of this equipment that's coming home with you, and let me just give you a quick five-minute overview. Good, now you're trained. I can check off that box. Take that equipment home with you.

These transitions of care are moments where not only is a family caregiver thoroughly stressed, perhaps they've just found out that their loved one has a chronic condition or a fatal condition and now they have to absorb that their life has changed, their loved one's life is ending, and they have to now become a pseudo-medical professional. These moments of transition of care are when the training takes place for home medical devices.

Family caregivers also perform instrumental activities of daily living, or their IADLs. They provide or arrange for transportation. They'll probably do the housework, the grocery shopping, preparing meals, manage the finances. They will give the medication. They will actually get that patient to swallow a pill, which especially in Alzheimer's and other dementias is a very, very serious and difficult issue. They will give injections. They will arrange or supervise for paid support services if they are either eligible or they can afford them. And they will -- and this could almost be a full-time job -- they'll navigate insurance, but that would be a conversation for another day.

What this comes up to is what we call the caregiving burden, and depending on the condition of the care recipient, we divide this into low burden or high burden.

Family caregivers do report a strong financial hardship, worsening health due to caregiving. That family caregiver who's small and the husband who's large -- and there are a lot of physical therapy issues, pulled muscles, back strain, chronic conditions happening on the part of the family caregiver.

We could also look at low burden and high burden based on the average number of ADLs that are performed by the family caregiver. I've highlighted that one because, when you're looking at medical device use in the home, you're typically looking at a high-burden family caregiver who is performing three or more ADLs in the home already.

Now, caregivers have self-reported, whether they're low burden or high burden, they want more help and more information. And that, I'm not talking about just the hands-on help. Of course, everybody wants that. They need whatever we, all of us, can do to help them perform their duties, to help them improve their own quality of life and the quality of life of the care recipient. Another recent study was done, and 87 percent of family caregivers turn to the Internet and technology for assistance.

So all of this burden, how does it impact family caregivers? Well, a lot of studies have been done on this. Stress. We can use that as a casual term or we can use that as a studied term. Stress of family caregiving for persons with dementia has been shown to impact a person's immune system for up to three years after their family caregiving has ended.

Family caregivers are more depressed than the general population. Those who provide 36 or more hours weekly -- there we're talking of that high-burden family caregiver -- are more likely than
non-caregivers to experience symptoms of depression. If you are family caregiving for your spouse, that rate is six times higher than the general population. And if you're family caregiving for your parent, that rate is twice as high, unless of course it's my parent, in which case it's just off the chart.


MS. WINSTEL: Okay, chronic disease. Family caregivers -- documented, medically documented, proven studies -- family caregivers have chronic conditions at more than twice the rate of non-caregivers, and there are many reasons for this. One of them is that family caregivers tend to simply not take care of themselves. They neglect their own health. They are so focused on taking care of their care recipient, they don't take care of themselves. The more that we in this room can do to support a family caregiver in that role, in their role, the better the health outcome for the family caregiver as well as the care recipient.

Family caregivers are shown to prematurely age. The level of stress can take 10 years off a family caregiver's life. There is an increased risk of mortality. Studies have been done. A wife's hospitalization increases her husband's chance of dying within a month by 35 percent. A woman, even more likely to die if her husband is hospitalized.

So I was trying to get this out to you because I think it's very important for industry to understand the people who are using the devices that you make. This is the story. These are people who are highly stressed. I edited this presentation down so we can get more to some of the discussion.

But in addition to all of this, family caregivers are employed. Seventy-seven percent of all current family caregivers are also currently employed, some full time, some part time. Eighty-three percent of those who are employed report having made a change in the workplace to accommodate their caregiving.

Another area of study that we're looking at, at NFCA, is the fact that a lot of family caregivers will not self-identify, will not let anybody at work or anywhere else know that they are a family caregiver because they are very, very worried about experiencing employment discrimination. This particularly affects male family caregivers in the workplace and especially now that we're looking at still a tightened economy and tight employment. This prevents family caregivers from reaching for help for additional supports.

So they're employed. They've got all of this stress going on. There's a transition of care. A medical device comes home. They're shown once, if they're lucky, by somebody who knows how, how to use the device, and then that's it; your product is in the home.

Sometimes, let's face it, the devices are too complex for family caregiver use. There are devices that go home that you never intended to be used in the home. It happens. It's not supposed to, but it does.

The instructions and manuals for some of these devices were never written for a family caregiver audience. This is my moment to talk a little bit about health literacy. I have not included, intentionally, any of the demographic breakdown of family caregivers because it's everybody, and because it's everybody, it's all different levels of education. It's different language comprehension. It's different abilities to read and comprehend these instructions. As I've really, I hope, emphasized, when the instructions do occur, they happen at a stressful time.

One of my colleagues recently lost his wife to brain cancer. She completed her life at home per her wishes, and there was hospice care, but there was not hospice care 24/7. So she came home, and there was a hospital bed and a nurse was with her, and the nurse, at that moment when my colleague is seeing his wife in her home, knowing that she will be dying in a matter of days, she said, okay, now let me show you how to clear the trach, okay? And that was it. That was his five minutes of instruction, and that's not atypical, and that's a not a moment to be learning that.

The device labeling does include some confusing things. I'm not trying to say that all family caregivers have low education levels. We represent complete walks of life, but it's hard to absorb. And the devices might not be compatible with the family caregiver's capabilities, lifestyle, or environment.

There is some interesting reading on the FDA website about some of the adverse events. You've got a pet in the house; there's dander getting into tubing. You've got children who go, oh, what happens when I push this button, even though you've told them not to. My favorite story, I guess, because there wasn't a fatal outcome, was about the person with the pacemaker implant and his son was driving the radio-controlled cars across daddy's chest. It happened. He lived. It was okay, but still not a good situation.

I lived in Akron, Ohio. A wonderful town. Lousy water. If I had ever used that water to clean a device, I could have seriously damaged somebody's health. But it's tap water. You don't think about it. If something says tap water, that's fine.

When you think about historic homes and you plug something in and you have maybe one rated outlet in the house and you plug that in and you turn on the air conditioner and you turn on the television and that device is no longer working properly.

A device that's delivered to the patient is not always exactly what the prescriber described in the office or in the hospital or exactly what they prescribed. It might be what was in stock. It might be what the insurer would cover. It might be what the family caregiver went online and bought secondhand cheaper because they didn't have any coverage.

I talked about pets and children in the home environment.

And then there's the maintenance, and one of the issues about maintenance is that we've got a device coming home, the training happening, the distressful transition of care, and then some maintenance has to happen maybe that day, maybe later that week, maybe a month down the road, and the family caregiver is standing there and saying, I know somebody showed me how to do this, but I just can't remember.

So they call, let's say, for example, the doctor's office. That would be a good, logical place to first turn. And you have to get through the phone tree, and then you have get through the receptionist, who's going to say, well, I don't know who you should talk to because you're not scheduling an appointment and you don't have a billing question. And the nurse might have absolutely no hands-on experience or know exactly what device make or model you have at your home, and by then who knows what might have occurred.

Again, I know this is not how the devices are intended to be in the home, but it's a hard, cold reality that once this goes out into the environment, it is not in your control anymore.

So if there was to be some sort of online repository, what could it do? How could it impact family caregivers and their loved ones? For starters, it can really reduce caregiver stress. Reducing the caregiver stress is going to cut down on their diseases as well, and that's also going to have the potential to reduce adverse outcomes, plain and simple. You're going to have the potential to improve patient outcomes because the devices are going to be used correctly. You're all going to improve consumer relations because we're going to demonstrate the commitment of industry and government, that you are all committed to make sure that the patient is as healthy and has as a high quality of life as possible.

We were talking earlier about identifying what is the right problem. What do we need to address here? What is the need? I think the one thing that we can start with is that there is a need for people in the home to be able to use devices safely, as they were intended, so they can get well and they can benefit. Who can benefit? 65.7 million family caregivers and their loved ones could benefit.

How should we slice the pie? What devices should we look at for putting in some sort of online repository? At National Family Caregivers Association, we say that you should start with those devices that are used in the home. Now, I say, the ones that are used in the home, not just those that are intended for home use.

I'll take questions.

MS. ZOREN: Ann Zoren (ph.) from Baxter Healthcare Corporation.

I appreciate, I mean, your talk is very clear and I don't -- I truly understand that there's an issue. I'm also well aware that there are devices that are designed for the home that do address the issues that you raised in terms of labeling that is clearly understood and designed for people with varying levels of education.

But I'm interested to ask FDA, if clearly there are devices that are being taken into the home that are not intended for home use, in order to address the need of the family caregivers, that labeling would have to be revised. That would present a burden on industry. But even if industry would do that, that's industry's acknowledging that their devices are being used for an off-label use. So how would FDA deal with that?

MS. WEICK-BRADY: I might want to throw that right back at you and say how would you deal with it, knowing that these devices are migrating into the home environment whether you want them to go there or not, and we need to make sure that there is safety for patients and that the majority of patients are going home with some type of medical equipment, that this does need to be considered.

In order to answer your question and not be too smug about it, we are working on a guidance document for devices that are labeled for home use, so that industry has something that they can follow. And there is an international standard for home medical electrical equipment that is now available for manufacturers to follow if your intent is for that device to be used in the home.

Now, the area of devices migrating into the home that are not labeled for that, that's out of FDA's control. That's typically a practice of medicine issue in that they're being prescribed for home use even though they're not labeled for that.

MS. WINSTEL: Actually Jeff and I were having a little discussion about this before lunch, and one of the suggestions that I would make is that if a family caregiver clicks on a device that they're using in the home and say, yeah, I'm using that, and what comes up is a little URL that links to your site, and instead of directions they see the following message or some simile of this message: This device is not approved for home use. We do not endorse its use in the home. If you're using this device in the home, please contact your healthcare provider who prescribed it.

MS. ZOREN: And then what?

MS. WINSTEL: Close the loop back to the medical professional.

DR. NELSON: I'm going to speak as a practitioner. That's just completely unrealistic. And giving a patient or a caregiver the message that this device that you've been sent home from the hospital with is not approved for home use is only going to add to the stress.

To me, you know, my own personal view of it is that we shouldn't try to be the Catholic Church and decide what people should know and not know. I mean, you know, Galileo had a lot of trouble with that. And you know, I mean DailyMed, that's largely information for prescribers, but there's a lot of people out there who go and they read through that, and it helps them whether or not they've had any medical education or any higher education.

So I don't think we should try and sit on having some information available. Whether or not it's an off-label use and it's not intended to be in the home, do we have a responsibility to provide the information? You know, if the information is available, I think we need to consider how we make it available and not hide it because it's not supposed to be seen for people at the home.

MR. SECUNDA: This is Jeff Secunda.

It's not a matter of hiding the information. I think that a point was made that you're essentially forcing a manufacturer to take on a responsibility that they are not prepared or willing to do. So, you know, just throwing the information out there, it isn't just the information, it's the responsibility for the information.

And if the device is being used in the home and something goes wrong because the user didn't know what they were doing, that's going to go back on the company. So the company has two positions. It's either, oh, gosh, you know, we have a problem, or we had no intent of doing that.

And I think what Lisa is saying actually shifts that responsibility to the person that prescribed or designated the equipment, that they -- if they're going to send this equipment home, they have to send the appropriate information with it. It's their responsibility, not the company's.

MS. WINSTEL: Jeff, thank you for reminding me of something which I think I did, in my speed, leave out, and that is the issue of the piece of paper. Let's call it the printed instructions. I don't want to imply that the manufacturers are not providing printed instructions or that they're not given to a family caregiver. But I do want to be very clear that I am implying most emphatically that they are usually not found at the moment of need.

And so having a backup place to turn to, whether it's some online repository of information, can be extremely beneficial so -- to the point that if the medication -- if the instructions were provided when equipment came home, even though the equipment isn't labeled for home use, and then I lose those instructions or I can't put my fingers on them at the time that I need them, well, I was already given the instructions, is there really a downside of my then finding them from a different location, from an online source that's trusted?

UNIDENTIFIED SPEAKER: -- from KCI in San Antonio.

A question. What is your statistic of the number of home health providers who do not have Internet access?

MS. WINSTEL: Actually we're about to find that out for you, and I'll have that data probably by June. We have that information in the field at the moment. Every indication so far, from some preliminary studies that other organizations have done, indicate that family caregivers by and large, well over 80 percent, are receiving information via the Internet. What we're going to be finding out shortly is something about high speed that is and whether that's actually accessed in the home or through a community center, a library, et cetera. So we'll be having that for you, but just don't yet today.


MS. WINSTEL: Okay, thank you.

MS. WEICK-BRADY: Thank you. And now we're going to open this up for public comment. And we did have some people who did register for the public comment period and we'll have you go first. After that, if there is still time, anybody else in the audience who does have a comment to make or a question to ask of us, please feel free to do so.

I'm going to ask Mark Leahey of MDMA, did you get everything covered that you wanted covered earlier or do you still want to make your public statement? If he's still here.

(No response.)

MS. WEICK-BRADY: Okay, I don't see him. Elizabeth George is next.

MS. GEORGE: First I want to thank the FDA for having this meeting bringing together the stakeholders so that you could hear the different perspectives. My name is Elizabeth George. I work for Philips Healthcare. I'm the Vice President of Global Government Affairs, Regulations and Standards.

Philips is a very large company. We presently have over 50 sites around the world. We manufacture presently over 800 different medical devices. They range from the Sonicare toothbrush that probably many in the room have -- yes, that is a Class II medical device. People may not be aware of that. We manufacture home or public access as well as hospital defibrillators. We have patient monitors. We have apnea equipment, both for home as well as hospital. MRI, CT, CAT scans. You know, all different types of x-ray. So quite a broad spectrum. And we also deal with all of the associated supplies and various services, training services, maintenance, et cetera.

And one of the products that hasn't really been talked about much here is software-only products. We also make quite a bit of software only, where it's literally a CD. So one of the comments about photos is, so we do take a picture of the CD? I don't know what difference one CD product from another would be.

We are predominantly in the 510(k) realm of the world, but we are moving to the PMA world. We're moving a lot faster than we had hoped with reclassification of devices that are happening on an ongoing basis.

Very simply, we at Philips are trying to understand the real need and purpose for this public database and the photo library. We're wondering how the FDA, in their strapped state of affairs with both resources limited in the financial as well as people resources, are thinking that they're going to be able to do this.

Our devices ship with the instructions for use and associated labeling. It's also been unclear to us as to what the scope of the labeling will be. There's instructions for use. There's service manuals, technical manuals, clinical manuals. There's all the warning and caution labels. On a CAT scan, there's in excess of 50 different labels that are stuck on the device itself. So we're wondering which of those are intended to be in this.

We do understand the importance in what is encompassed in labeling. We've been in the business for a very long time. Philips has been around kind of forever, x-ray equipment's been around for a long time, and we are a conglomerate of 27 acquisitions in the last seven years, so we've got lots of diversity and experience.

Most of our devices are used by professionals and require training. Photographs and marketing material of our devices are visible on the website, so it's unclear what the purpose of this secondary site would be and how it would improve the safety and efficacy.

We do understand, however, the potential value of home health products to support home care providers, whether they be family or professional. But it should be realized that one database and one system does not fit all.

Just as Mary Brady mentioned at the opening, the users vary, the skills vary in the types of devices and the legacy devices are out there. So questions and support should go back to the manufacturer, not to a central database.

To mitigate the risk of potentially using the wrong labeling or not being properly trained, we feel that, again, it should go back to the manufacturer.

We do look forward to working with the FDA to identify the optimal necessary solutions, and I thank you very much for the time.

MS. WEICK-BRADY: Thank you, Elizabeth.

Okay, we also have Brian Connell.

MR. CONNELL: Thank you, FDA, for holding this meeting. I want to say that MITA's member companies strongly support giving both patients and caregivers the information that they need to make informed healthcare decisions and providing healthcare providers with the education and support that's necessary to ensure that patients receive the maximum benefit from our products. At the same time, MITA does have a number of concerns with the initiative that FDA has proposed, and we'd like the Agency to address those moving forward.

Our member companies want to ensure that the information that's included in this online repository remains focused on benefiting its intended audiences. To that end, FDA should evaluate information required for this labeling and photo repository using one primary criterion, helpfulness of the information to the intended audiences of consumers and healthcare professionals. Only information which is directly beneficial to these groups should be considered for inclusion. And to maximize the benefit for this new repository, the FDA should first focus its efforts on consumer devices, since such devices place the largest information burdens on patients and caregivers.

Only after establishing, implementing and evaluating the Agency requirements for these products should FDA consider expanding the repository to professionally operated prescription products.

As FDA defines information requirements, the Agency must fully protect intellectual property rights. The owners of the intellectual property must have the final say in what constitutes proprietary information to prevent the repository from undermining medical innovation.

Given the broad definition of labeling, MITA definitely appreciates that the FDA is working to narrow this definition in this context, including the Agency's recognition that operator and service manuals will not be included in the repository. Collateral and advertising materials should be added to this list of excluded information.

In short, labeling information requested from manufacturers should mirror current information requirements rather than require additional resources, and that's why MITA urges FDA to confine labeling requirements for this online repository to a concise list of helpful items already included in public information made available by each company.

The Agency needs to consider the problem of old labeling as well and how it will be addressed. Medical imaging products specifically have a very long shelf life, with several different models in use at any given time. Presenting the relevant labeling information for each item could be more confusing than useful for some intended audiences.

One area that demands Agency flexibility is device photographs. Many medical imaging devices are large systems with component parts in separate rooms, and this makes inclusion of all components in a single picture problematic. Any Agency requirements should take this into consideration. The best solution is for FDA to limit any photo requirements to the photographs the companies already make publicly available.

Although these parameters will lead FDA in the right direction on this initiative, MITA has a number of other concerns with the effort. First, FDA needs to thoughtfully consider the impact of promoting this new repository as a source for healthcare professionals operating medical devices.

Manufacturers, especially medical imaging devices, devote extensive resources to operator education, training, and support. If an operator has a question regarding the use of a medical imaging product, the operator should always contact the manufacturer for an answer. Manufacturer support mechanisms exist to ensure the operator receives an answer.

The FDA should not include any information in the repository that would encourage device operators to substitute online information for interpersonal communication with the experts on the customer support teams of the manufacturer. Moreover, this effort does raise some liability concerns for both manufacturers and the Agency in the case of a serious injury resulting from information contained in the repository.

Second, before moving forward, FDA needs to clarify how the new information requirements envisioned in this initiative will impact the clearance or approval processes. MITA urges FDA to clarify that the information submission and update process required for this repository is completely separate from the 510(k) submission process and will not lead to clearance delays.

MITA would strongly oppose requiring final labeling to be submitted in advance of or as a condition for device clearance. Patients awaiting the benefits of new technologies just can't afford another obstacle that extends the already lengthy process.

Finally, MITA remains extremely concerned that FDA is not currently resourced to design, establish, and maintain this proposed repository. Clearly, creating and maintaining such a database would be an enormous resource burden, especially if the Agency intends to screen submitted information for every cleared product in advance of posting online. If repository updates are required for small labeling changes like those addressing small typos, this effort will require substantial time and effort from both manufacturers and the FDA. And given the current federal budget constraints, MITA believes FDA would best serve its core mission by focusing its resources on approval and clearance efforts.

So MITA looks forward to continuing to work with FDA to reach our common goal of empowering patients, caregivers and healthcare providers. Thank you.

MS. WEICK-BRADY: I just want to verify that there's a couple questions for Brian. Should we wait until the public comment is over or --


MS. WEICK-BRADY: We can wait, okay. Let's finish up with the public comments, and then we'll have questions for those who made public comments.

Next, I have Tamima Itani.

MS. ITANI: Hi, my name is Tamima Itani. I'm Vice President of Global Regulator Affairs with Boston Scientific, and I would like to thank FDA for providing this forum today for further understanding the needs related to labeling and photograph repositories.

As we sit here today, frantic negotiations are taking place not too far away from here, trying to avoid a government shutdown, with the debate focusing on how to reduce government spending across the board.

U.S. healthcare costs have skyrocketed, and the U.S. has one of the highest healthcare cost burdens as a percentage of GDPs worldwide. Several well-designed and research evaluations published earlier this year have shown that the U.S. medical devices industry is starting to shift its operations and innovative product launches abroad, with the primary driver behind this shift being the regulatory cost to introduce and maintain medical devices in the U.S.

So as we look for potential answers regarding whether and how to implement labeling and photograph repositories, all parties must remain acutely aware that the cost of developing and maintaining the databases and the cost for manufacturers to provide and maintain the information ultimately translates into increased healthcare costs to the consumer, an increased cost of doing business for U.S. manufacturers, further encouraging them to focus their new product introductions abroad.

We do want to work with the Agency to meet consumer and healthcare professional information needs. However, the solutions for potential labeling repositories and photograph repositories must not assume an open checkbook approach and must include overall cost benefit considerations. In these difficult economic times, solutions must leverage existing systems and processes and must be highly frugal in their implementation. Thank you.

MS. WEICK-BRADY: And I'm going to ask Mark Bayer of Reed Technology to come up. Mark needs access to the Internet and I think -- do you remember how you did that?

MR. BAYER: Hello, my name is Mark Bayer. I'm the Vice President of Business Development at Reed Technology and Information Services. We're up in Horsham, Pennsylvania. And I had no expectation of being up here today, and I am not here in any advocacy position at all. I was talking at lunch with Mary, just explaining to her what we do for a living, and she asked if I would give a demonstration of the service I'm going to show you.

As a point of background, we are on the CDER side. As mentioned, I think, by an earlier speaker, CDER had mandated back in the fall of 2005 that all drug labels, at that point initially prescription drug labels, had to be submitted to the CDER folks for approval in SPL, which is an XML schema. There are many, many drug firms who said XML is not our business, and so they outsourced it to people who do handle data conversion as their business. That's what we do at Reed Technology. We are the leading provider of outsourced drug conversion.

So if you're pharma X and you have your labeling and you want to submit it to the FDA in SPL, we'll be happy to do it for you. We'll charge you a fixed fee. You'll know what your costs are, et cetera.

To give you a sense of scale, since 2005 we have converted over 11,000 SPL documents for our customers. They range from the very biggest pharmas in the world down to one-label startup companies who are hoping to strike it rich and be acquired by one of those very biggest companies in the world. So our business has been going well.

About two years ago, with the introduction -- well, the DailyMed, as Stuart said, started way back when, in the fall of 2005, with one label, and it has grown over the years. About two years ago we introduced a product called LabelDataPlus. Utilizing the content found in the DailyMed, we did something which is classic in Washington, in the sense that -- or, you know, in the private sector -- taking something good that the government has put together and putting extra value into it. And we developed a service called LabelDataPlus, a free website which took the basic content but added certain functionality and value add to it and made that available to the public.

But I'm not going to show you LabelDataPlus because just a couple days ago we announced our collaboration with PDR, the Physicians Desk Reference, and now LabelDataPlus has migrated into something called PDR3D, 3D standing for Digital Drug Database. So I will show you that. Conceptually it's the same with some improvements on it, and there will be many more improvements coming. So give me a moment to see what I can get started here on.


MR. BAYER: Okay, it's there. Okay. So this is the PDR3D welcome screen. The functionality that you're going to see here is very similar to the functionality -- it has some improvements -- to the functionality that we had in LabelDataPlus. I'm not here trying to give a commercial either. What I'm trying to do is just be helpful and demonstrate something that private industry did to put together and to improve, if you will -- and enhance would probably be the better choice of terms -- enhance on some value that already is being provided by the DailyMed.

And I should make it very clear, the DailyMed -- we do not get 11 million hits or page views a month as Stuart does. You know, we're looking to -- we're selling a subscription service here for people who need it, be it once again a large drug firm down to maybe a small research organization.

Okay. So I'm just going to give an example. So what this is doing is I can do a search.


MR. BAYER: Ticlid? Sure, I'll do Ticlid as Stuart had done this morning. So there's Ticlid and I hit the search button. It's all very straightforward. And here is Ticlid. So far, not much different than what you saw this morning.

So if I want, I can look. This is a product from Roche, and now I am looking -- once again very similar to what you saw this morning. I am looking at the Ticlid drug. There is a box warning, and then there is the graphic of the chemical structure and very much the same information you saw this morning when Stuart was showing it. There's tabular information, et cetera, et cetera. And down here is what is known as the drug listing information describing active and inactive ingredients, et cetera.

Now, what you see here is pretty much what you saw this morning. Now, let me show you some other stuff. And something tells me I'm not where I want to be. Excuse me, bear with me one moment. Let me just start this again somewhere a little differently.


MR. BAYER: Okay, a new search. Okay. So you know, this is the typical thing. Murphy's Law is here. I called during lunch. After having spoken to Mary, I called to see, hey, everything going okay back at the ranch?


MR. BAYER: Okay. Okay, now we're in the little separate place. So if I put in a name or a national drug code number, just as on the DailyMed, I get a result. Just like we showed Ticlid this morning, Ticlid this afternoon. However, if I want, I can also do some additional searching. So if I wanted to look in a particular field -- is something missing here? I'm sorry, there is something missing here. Well, it always happens. There we go. Okay, they actually changed something.

Okay. So now the value add, the main value add that we've put in this is the ability now to search by certain characteristics. So if you know the name of a drug, that's one thing. But what if you wanted to know all the drugs that had a certain active ingredient that were manufactured by a certain manufacturer, et cetera? So let's say the sponsor in this case -- and this is very hard to see, and once again I do apologize. I wasn't planning this, and I can see where there are a couple of things I'm not pleased with.

So I'm putting in the sponsor is Pfizer, and let me search for that. So of the 34,000 drugs here, 122 of them are from Pfizer, and I could look at any one of these drugs. I could also refine the search, though, using some Boolean search logic, and I can come down here and I could also say, where an active ingredient -- and I am not a scientist, as anyone will -- I'm going to do it a little differently -- where the dosage form is a tablet.

So now I'm doing a simple Boolean search. You've seen systems like this a thousand times. But now you can see I'm down to 56 drugs out of the original 122. And if I wanted to refine the search some more, I could do that and I could use some RxNorm information or I could put in, let's say -- and I know this is very hard to see. This is black type, a dark gray type on a dark gray background. Something is different than what I saw when I left the office yesterday, so I apologize for this, and this will not persist, but it's the way it is now.

And if I wanted to, I could put in -- let's say an active ingredient is aspirin, and I'm not suggesting aspirin would be an important active ingredient here, but -- and I came up with nothing. So I will go back and I --


MR. BAYER: Good enough, thank you. Whoops.


MR. BAYER: Atorvastatin. Is that correct?


MR. BAYER: Whoa, got lucky on that one. And now I'm down to two drugs, and there's Caduet and there is Lipitor, at which point I can now display either of these drugs, Lipitor being one that Stuart had shown this morning also.

Notice also in the way -- let me just go back one second for a moment, please. Notice that we show the brand and the generic name. You can sort by any of these values. The sponsor in this case is Pfizer. Here again is Pfizer. The version, this is the eighth version of Caduet, the most recent one on that date. It's a tablet; it's film coated. There's the NDA number, et cetera.

So the point I was trying to show and Mary had asked me quickly to show is that we have taken some really good content that gets a great amount of use. We have put some extra value into it, except for this demonstration, unfortunately, and we have then, you know, created this additional value for the user community.

We can see, for instance, here that we are viewing the eighth version. There are previous versions. We could click to view any one of those. We also have some documents that are sold by, not a sister company, but a partner we work with, FOI Services. And we could go, for instance, directly to the product listing information, et cetera, things along those lines.

So I just wanted to show you that you can take some good information and add additional value to it and make it that much more functional. Okay. You're welcome. Sorry for this bad what do you call it, this really poor coloring. I'm going to check that as soon as I get out of here. Thank you.


MS. WEICK-BRADY: You can talk to our human factors person over here. She knows how that goes.

MR. BAYER: I don't even need to speak to anyone.


MS. WEICK-BRADY: Okay, are there any more people who would like to make a public comment during this period? Come on, come on, this is your chance to talk to the FDA. Don't be shy.

(No response.)

MS. WEICK-BRADY: If not, I'm looking at Joyce. Do you want to take an early break and start up early with the Panel session? Right. And the sooner we come back, the sooner everybody can probably leave. And we hope you stick around. This could be a very interesting Panel session.

So 15 minutes and we will start at 2:10 or 2:15, okay. So please rejoin us at 2:15.

(Off the record.)

(On the record.)

MS. MENDELSON: Good afternoon. We have our final session coming up, so I hope you'll find your seats. We're going to spend the next hour and a half or so having a group discussion about some of the proposals that we discussed this morning.

But I understand, before we do that, we need to issue a public apology. Apparently it's our browser system that caused all of the difficulties with the presentation that you heard just a few minutes ago. We don't have a current version of Internet Explorer, I guess it is, to show the website in its appropriate colors. So on behalf of FDA, I'm very sorry for that.


MS. MENDELSON: If we get a budget, maybe we'll update.

DR. NELSON: A major challenge of hosting websites is browser -- you know, is being able to maintain for all these different browsers. It's a nightmare.

MS. MENDELSON: So, again, thank you for coming back. Just a couple of logistics for how this will work this afternoon. We've spent all day, so far, hearing kind of one-sided presentations. Each one of us who have spoken already have given a statement, and what we'd like to do in the remaining hour and a half to two hours is to open a dialogue, open a conversation among all of the participants.

I hope, after I introduce a question, that our Panel members will speak to one another, to each other, answer each other's questions. If you feel like you're not being heard and you'd like to get my attention so that I can, with the power of the microphone, help you get a word in edgewise, just signal to me, and I will talk loud and make people stop talking and listen to you.

For those of you who haven't been up here yet today, the microphones work only by pushing the center button. Otherwise nobody will hear that you're speaking. We'll leave an average of 10 minutes or so for each of the questions, but we'll take it from there.

Let me remind each of you, when you do have the power of the microphone, we'll remember our friends Calvin and Hobbes, that we'll keep the comments as brief as possible to address your point, so that everyone has the opportunity to speak.

And before we begin, before we go any further, I wonder if we could just work the way quickly down the line. Could everyone introduce themselves and say who they're here representing today?

MS. WINSTEL: Lisa Winstel, National Family Caregivers Association.

MS. BENNEWITH: Alex Bennewith, American Association for Homecare.

MR. SECUNDA: Jeff Secunda, AdvaMed.

MR. CONNELL: Brian Connell, MITA.

DR. NELSON: Stuart Nelson, and as of today, still the National Library of Medicine.


MS. GEORGE: Elizabeth George, Philips Healthcare.

MR. BINION: Steve Binion, Beck and Dickinson.

MR. KILANDER: Chris Kilander, Cook Medical.

MS. SHRADER: Pat Shrader, Medtronic.

MR. MOSKOWITZ: Aaron Moskowitz, Biomedical Research and Education Foundation.

MS. NUSGART: Marcia Nusgart. I wear a couple different hats. I represent a number of different coalitions and medical devices in the home care arena, such as respiratory, enteral nutrition, wound care as well as an alliance of wound care stakeholders, which is an umbrella organization representing a number of different clinical associations that provide treatment for patients with wounds.

MS. MENDELSON: Thank you all very much.

Let's start right in on the good stuff. You heard FDA start this morning by introducing the idea of a labeling repository. We've heard pros and cons on each side of the issue. I'd like to ask now if you support a labeling repository. If you don't support a labeling repository, what is the best way to get labeling information to the public to ensure that the public has access to labeling information?

Jeff, do you want to start us off?

MR. SECUNDA: Jeff Secunda, AdvaMed.

As I stated, you have to go to the source. The manufacturers are responsible and are the creators of the information, and I think that is the best way to ensure that the public has the information that they need and that is appropriate for them.

DR. NELSON: I'll take the contrary view. Our experience at the library is that people go bankrupt, manufacturers go bankrupt or publishers, we have a lot of experience with publishers who go bankrupt. What they've said was going to be available is no longer available and that we think that things should be in some place that has a guaranteed life, forever, and which is why we developed PubMed Central, but there are other repositories for published information out there. But it needs to be someplace where, regardless of the viability of the company, the information is still there as long as the information need is there.

Great to say that we're about to shut down.


DR. NELSON: There are some very interesting debates about what's going to happen with the .gov websites if the government shuts down. During the last furlough episode, we didn't have that real issue, but now this is going to be a major -- this is going to be a big issue.

MS. BENNEWITH: I'd like to add a point with the labeling. Obviously it makes sense for the labeling to be available with the product, as Lisa and others were mentioning earlier. That's key to be able to quickly make adjustments to the device.

The other thing that I want to highlight is that a majority of beneficiaries that we're familiar with, we represent healthcare providers and manufacturers throughout the country. For those patients who do not have family caregivers in their home or close to their home, the first person they call is their healthcare provider for assistance. So not necessarily the Internet, actually.

I mean, I know you say that caregivers go to the Internet, 87 percent, you mentioned. But if you look at the typical beneficiary user, a 75, 80-year-old elderly with Alzheimer's disease, she's not automatically going to think, oh, let me just think such and such website. She needs something that she can get her hands on that's easy to read at a very basic level. So paper versions are definitely a good thing. Thank you.

MR. KILANDER: Chris Kilander from Cook.

I would like to counter that a little bit and talk about devices that are used primarily by physicians, and in some cases the labeling includes significant amounts of clinical trial data, patient selection criteria, and other information that really is best made available to the physician prior to receiving the device, and when the device actually arrives is not the ideal time for him to see it, particularly if you are the patient on the table and you don't want your physician fumbling through 200 pages of clinical trial data and other information trying to find that key point for you.

MS. NUSGART: This is Marcia Nusgart, and I'm in agreement with that and the fact that I believe the manufacturer is probably the best source for patients and healthcare professionals to be able to learn more about the device, and then God forbid if the device is no longer in existence, who is best to be able to address this, you know, than the manufacturer and their website?

Because what I would worry about, if something is no longer in existence, who is going to be updating all of this? And would the onus be on the FDA? Would the onus be on the manufacturer to take it off the FDA website, if you still had this particular type of labeling repository?

So, again, I think that the manufacturer should have that onus because at least they would have responsibility for the content of it at that point in time.

DR. NELSON: But what happens if the manufacturer goes out of business?

MR. SECUNDA: Well, that creates problems for getting spare parts and all the other issues.

DR. NELSON: Yeah, yeah.

MR. SECUNDA: And so is the government going to have a warehouse for spare parts?

DR. NELSON: No, but the people who are out there and are using the device and they need the information about the device, even if the manufacturer has gone out of business, they still need the information. You can't go to a website of a company that's out of business and get the information.

MR. SECUNDA: No, I understand. I'm just making the point that it's not just the information; it's the parts for the device and the supplies.

DR. NELSON: Oh, absolutely.

MS. MENDELSON: Aaron, do you have anything more to add to this?

MR. MOSKOWITZ: Yeah, I just want to emphasize that point. It's information, and we're talking about the stage where all of this information is available or will be available online. You know, it's an old argument already. So to bring in the physical components, it's a different discussion. Not quite the same thing as saying this is, you know, just the information that could be put online. You know, it's different.


MS. SHRADER: I did just want to comment from a manufacturer perspective. I appreciate everything that I've heard on this issue. You know, what we try to do for customers is make sure that they have the information that they need at the time that they need it.

So I think Jeff mentioned earlier this morning that in many cases, you know, we're training people and giving them instructions before a device actually gets into their hands. We try to make sure, to the extent that it's physically possible, that there's identification on our products so that if somebody, you know, a pathologist, for example, finds a device in a deceased patient and wants to try to track it down, if at all possible, that they know who to call. We have technical service people who are available 24/7.

Even our online manuals say, you know, if you have any questions or any problems, call this number. Somebody will try to help you. We'll walk through this with you, help you identify the device that you're trying to identify.

Having said that, you know, any system that we have is highly likely not to be a perfect system. As companies, we do the best we can. You've obviously also heard from other entities who are also trying to provide information about devices to help people understand what the product is, how it's used, what the precautions and limitations are.

I think it's something -- I do applaud FDA for having started the dialogue today and also for having brought out that this is really a very complex issue. There's not one easy answer to the question. So I think that further discussion is definitely merited.

The other comment that I would make is, you know, regardless of the outcome of the decision that FDA is going to make about an online repository, I do think that we have to recognize that there will continue to be multiple sources of information about products, of which an FDA online repository might be only one. And it will continue to be challenging and perhaps even more challenging for people who are seeking information to make sure that they're getting the correct information, that they're getting up-to-date information, and it's something that we should all be cognizant of and try to work toward the best solution that we can.

MS. MENDELSON: Steve, I think you have a point.

MR. BINION: Yeah, just a quick follow-up. I think that the question itself needs to be somewhat more nuanced. I think really everything I've heard so far and my own thoughts on this, what we really need to address is what is the best way to ensure that the public has access to the labeling information that it needs? And I think that, quite honestly, is going to vary significantly by circumstance and the nature of the device in question.

MS. MENDELSON: I think that's a great way to end this discussion because we're going to follow up with those two questions in just a little bit. But before we move on to the next question, is there anyone sitting here who would like to add a comment for the record on this particular question?

(No response.)

MS. MENDELSON: Okay. So our next open question to all of you is kind of a multi-tiered question. You've talked about people presenting the best way to present labeling is through a website, the best way is through the manufacturer, the best way is through paper or instruction manuals, the best way maybe is through video or some sort of multimedia approach.

Can we open the floor to brainstorm a little bit here about what are the most effective vehicles for conveying professional information, first of all, and secondly, information for patients, consumers, and their caregivers?

MS. GEORGE: I think one of the things is, is during the 510(k) or PMA process, we identify the intended use and who the users are going to be. So as a part of that process, we have to ensure that we develop the proper communication to address that audience. So if it's a professional user, then that's how we would develop it.

And think earlier there was the question brought up about the concern of off-label use. I think if it's a home product, we develop our labeling with the understanding of the reading and skill capability. If it's a hospital-use product only that's being used in the home, clearly that labeling is not going to be appropriate and effective for a patient or for a home caregiver.

MS. SHRADER: I think the answer to this question is it depends. It depends on who the professional is, who the patient is, who the consumer is. It depends on what the product is. So those are things that companies try to take into consideration when they're making decisions about what information to convey, how do you best convey that information?

And I'll give you an example. If you were looking on the Medtronic website for a pain pump, what you will find is you'll find the labeling, the instruction manual for the product. You'll also find a video for the product, and part of that video shows you the product and kind of spins it around, you know, so you can see it from all directions, labels the parts of the product for you, and then kind of walks you through. Here are the things that you as a patient need to know. Here's information on cleaning, et cetera.

So I think it's a great question. It requires in many cases a very individual answer, depending on not just who the audience is but also what the product is, how simple it is, how complex it is, and what that particular individual's expected to do with it.

MS. WINSTEL: I'm so glad you brought this up. I think that's an excellent example, if I can keep building on that just a little more. I think that many manufacturers do have that level of excellent in-depth information, mixing multimedia and so on. I think that what I'm trying to do is get the family caregiver to that information effectively and efficiently.

So if they don't have their hands on it and they have to go to your website and they search whatever combination of words that they think are the appropriate words to search, how far down on Google is that website going to be? It's about linking the person to your information, linking that family caregiver to the manufacturer's information.

If we view the repository not for a moment as a repository, not as a database, but as a portal, if we can send family caregivers to a neutral portal where they can go, oh, I go here and I know that all I will see is the information that was developed by the manufacturer or maybe it's a link to that exact place that you were just describing for the pain pump, not any new information that has to be entered or vetted. Maybe what I'm doing is I'm going to the FDA site, skipping 20, 30, 40 listings on Google, skipping the distributors that we don't want to talk about who are selling third-hand parts, skipping all of the customer reviews, and getting that caregiver right to the really good information that already exists.

So perhaps the best and most effective vehicle for getting that information into the hands of the caregiver is some sort of neutral portal that lists all of the home-use devices. I find my device on that portal, and it takes me directly to the manufacturer's original labeling and website.

MS. BENNEWITH: I just want to go over a little bit what I had said earlier. Going along with what Lisa is saying, it's not that I support paper only, but again, you have to look at the audience. And, of course, we represent manufacturers and providers, and so of course manufacturers are able to update their websites in a very quick way. That is the other concern with the DailyMed, the ability -- it's a lot of work that's gone into it, it's a great website, but the ability to update it and the user-friendly factor is a concern. So I just wanted to clarify my earlier comment.


DR. NELSON: As far as the updating of DailyMed is concerned, it's a matter of two hours after we've received it from the FDA, which is generally the same day that the FDA receives it from the manufacturer. Okay. So it's not a long, long wait.

I wanted to talk about the most effective vehicles for conveying information. And I'm not good at names. The lady from Medtronic.


DR. NELSON: Pat put it very nicely. It's very individual. We all have very different learning styles. We all have ways that we bring in information better.

Okay. Now, having said that this is very individual, I think we might be able to maybe make some assumptions that professionals are probably more capable of dealing with complex information that's presented in what I'll call the numeral linguistic channel, that is to say, words on paper, whereas patients and consumers might be a little bit more visually oriented.

So I don't think we can say other than, yeah, there's tendencies in one direction or another. I don't think you can say that there's a most effective vehicle. There's trying to look at and say, well, let's look at how we can make information -- and maybe certain kinds of information are much better presented visually and others much better verbally.

MR. KILANDER: I like what Lisa was talking about in terms of a portal. Cook Medical provides all of our labeling online today, in addition to graphic images of our products, and most of our products are physician used and focused to physicians in terms of marketing. So there's very little in terms of patient use for our products, but we do still feel that there's value for the patients to be able to see that information.

But we also have concern in terms of having a repository. And I do recognize what Dr. Nelson has said in terms of what's been going on with DailyMed. But the recommendations from the 510(k) report do clearly talk about a potential to vet or review labeling updates before they're posted.

As a manufacturer, we want to be able not only to update that labeling as quickly as possible but update it in a way that we can ensure that if you have version A of the device, you get the right version of the labeling. If you have version B of the device, you get the correct version of the labeling for that particular version of the device because there may be differences in those two.

And if the FDA's system requires either a preview of that labeling and/or does not clearly differentiate between versions, it will not be possible for users or physicians to get the right information from that repository, if they are looking for that repository to be a definitive source for the label.

So being able to point back to the manufacturer resources, not only the labeling but videos, information for physicians, information for patients, from our point of view, is critical.

MS. MENDELSON: Thank you. Marcia.

MS. NUSGART: I agree with you with saying that it depends, and I also wonder whether you need to have two different vehicles, one as the professional one and the other as the patient/consumer area.

What was interesting is when I talked to a number of different physicians and nurses that I work with, they're much more technology savvy than a lot of other people, and time is really important, and it also depends on what they're using this for, too, because they were saying, oh, my gosh, is there any way that I can get an app for this so I can put it on my iPad and as well as, you know, the various phones that they have.

And that was very, very exciting for them to be able to have something like this so they could look at it when they're talking to the patient. They can just look on their iPhone or the various BlackBerry devices and see if there's an app and go to whether it is going to be a portal or to the company's website, because that's the best way for them to be able to get the information at this point in time, it looks like.

MS. GEORGE: If I go back to the question, when you gave us these questions in advance, you actually included things, of references of videos and professional seminars and things like that. Again, I think that it does vary on who you're trying to convey the information to.

I think manufacturers already today, with devices that are going to professionals, we make training available. Some products require training. Some products require certifications. So there are all of those, which goes to what you spoke to on, you know, face to face.

But one of the things I was chuckling about was, is if I think of drugs. In, you know, Us Magazine there was an ad for some drug that had the wonderful photograph of somebody dancing through the woods or something, and then three pages of everything that I could ever want to know about that drug. I'm technical, I'm clinical, I'm intelligent, and there is no fricking way I'm reading those three pages.


MS. MENDELSON: Does anyone from the floor have anything to add to this? You're going to need a microphone.

UNIDENTIFIED SPEAKER: Back to Lisa's comment. Most medical device companies that have labeling sites do advertise and promote the site with labels, effective use of labeling on the packaging or on the device itself. So to your point, a Google search should not be necessary if that medical device company is advertising and promoting their site clearly.

MS. WINSTEL: While that is true in an ideal situation, we're in the process of doing some additional research with family caregivers, and for example, the employed family caregiver, the sandwich family caregiver might be looking something up while they're at the office. They're not there with the device.

So we're trying to address the concerns that we're hearing from the family caregivers, how it's supposed to work. This is not to impugn the fact that I'm sure that manufacturers, of course, are trying to get the right labeling and information and instructions into the hands. The perspective I'm trying to bring is matching those good intents with the reality in the field.

UNIDENTIFIED SPEAKER: I have a question for Lisa, and that is, if the caregiver can't find the information at the manufacturer's website, how are they going to find the information through this repository?

MS. WINSTEL: Excellent question. The way I envision it, and I am not an IT person, but I really was thinking of it as very, very easily searchable, not repository or a database, I guess, in the way that it has a specific meaning to manufacturers, as it was something more to help me find the right words to look through and go, okay, that's my thing.

As a family caregiver, I don't think family caregivers need the label per se to be resident on an FDA website. What I think a family caregiver needs is a way to cut through the Internet noise. They want to make sure that they're getting to the right information through a trusted source. They want to make sure that they're not going to be inundated with ads through some sort of other consumer-oriented website that also happens to sell your products. We want to get them right to the right page. That's all.

MS. MENDELSON: Jeff, want to make a final comment here?

MR. SECUNDA: Yeah, I think that is clearly the objective, is to get the right information to the people that need it. And the issue of the trusted or noncommercial site is a personal thing, and I understand that.

However, you have to make a decision. Will you rely on the company that is providing the information to help you find the information? If you're not on the Internet and you call the 1-800 number, that's the person that knows, first of all, interaction with the public and they know the products and they're trying to help. This is not, you know, some IT customer service in another country that is on contract. This is a very important part of what companies do, what they have to do, and what they do to promote their business, quite frankly, is good customer relation.

So I really think that the customer service portal, if you will, is a very effective way to get the information as quickly as possible to the family caregiver, the patient, the professional.

MS. MENDELSON: Thanks, everybody.

This next question may be a little bit trickier. When you heard Mary speak this morning about the various possibilities of how we might implement a device registry, one of the options was to go through the Medical Device Registration and Listing System. According to the Medical Device Registration and Listing rules, we can only collect information on the label of a device and on the package insert.

So we all know what the label is because that's defined by the FDCA. The label is the actual words that appear on the packaging of the device. But what does the package insert mean?

So the question to turn back to all of you is, if we were to ask for the package insert, what should we be asking for? How should FDA define that?

DR. NELSON: I'm shy, so I'm not going to say anything. You know, it seems to me that as I've been listening here and learning a great deal, that really I think the device manufacturers have a great opportunity to define what it is that a label should be and a package insert should be because, you know, with drugs it was already pretty standard what kind of information people were going to want. It's not at all clear to me what device manufacturers have in common. And I think that maybe what we ought to be doing is talking about, well, who needs what kind of information and how do we supply it, rather than -- and then maybe turn around and, you know, talk about what a package insert is.

You know, in medications you can get out your whatever pill and get the box and open it up, and you get this little postage stamp piece of paper. By the time you get it unfolded, because it's been folded 32 times and you got six-point type there and you find your magnifying glass so you can read it, then you know what you -- that's what CDER calls a package insert. But you know, we may want to do it differently.

MS. MENDELSON: Here we have the opportunity to define what is package insert. So what would you like to see as part of the package insert?

MS. WINSTEL: Nothing less than 10-point type, I'm just saying.


MR. SECUNDA: Well, I think that you have a medical device industry providing products of such variety that to talk about a single package insert is really impossible. I just thought of it when you mentioned the -- you really can't fold things over 32 times, no matter how thin the paper is -- it's that CDER doesn't care if you can read the thing or not. It's just the legal requirement. Whereas, with devices you really have -- that's important information. People are going to use that information.

MS. MENDELSON: Let me clarify my question because I'm afraid, from the answers I'm hearing, that you're not understanding the question I intended to ask. We are only allowed to ask for the label and the package insert under the regulation and listing rules. So everything that we ask for in a repository has to be part of the package insert.

I'm not saying that it should be folded in half six or seven times or that it should be only in six-point type so you can read it. I'm saying, does this include the instruction manual? Does it include the installation manual? What does it include? Does it include the promotion and advertising?

We'll have to define what package insert means. That is not defined in the Food, Drug and Cosmetic Act. So I want to make sure that we are clear on what could be included in that term.

We'll take a question from the floor before go on.

MS. ITANI: So, simplistically, a package insert is what's contained in the direct packaging of the device. I mean, that's what it means to me. When I interpret that, it's what's shipped and contained in the packaging, direct packaging of the device or the shipper of the device if it's a multi-unit shipper.

Where it's become more complicated is when the labeling is so large that it's actually shipped separately, you know, such as for MRIs, CT scans, infusion pumps, and therefore to think that one term, package insert, is really going to cover all the scenarios that exist, today it does not. In a literal sense, a package insert is what's included with a package.

MS. MENDELSON: So what else could it be? Thank you.

MS. GEORGE: I agree with what's said, and I think that's the concern that we're having as industry, is that if we use just, you know, what's inserted in the package, depending on the products, if I look at what Philips makes is that we -- in some of our products we include the service manuals, we include the schematics, we include the installation manuals. There's a lot of things that are in there, and it also is all the caution and warning labels that are physically on the device. It's also, you know, the on/off button labels.

I mean, I think those are the things that we're wrestling with when we read the word package insert and to try to come up with, what does that mean to medical device industry, there isn't going to be one answer because our toothbrushes have that 32-page-fold thing versus our MRI machines that have, you know, volumes that weigh -- you know, the joke always is, is if the paperwork doesn't weigh as much as the device, it's not ready to ship.


MR. CONNELL: Which is why I think it's important to note that, seeming to me, a unified definition of package insert may not be possible. The diversity in industry is so extreme.

Jeffrey and I had a mind-meld in our slides. We both had a coronary stent and an MRI machine, and that's just one example or, I guess, two very diverse examples of what you see in the industry, and I think a package insert would need to mean different things for a coronary stent and an MRI machine or a radiation therapy machine.

And those are very different devices, very different users. You know, you'll never see a home care radiation therapy machine, at least certainly I don't imagine that in my lifetime. And so, you know, those are important things to consider. We'll need some latitude in that definition.

DR. NELSON: I have to say I agree that I've been convinced that you cannot lump it all. What we need are various categories of devices. For an MRI machine, maybe all they need is the 1-800 number to the operators that could actually tell you what you're supposed to be doing. But for something that -- you know, for my Accu-Chek machine at home, you know, God forbid that I should be able to find where that piece of paper was.

MS. MENDELSON: Marcia, I know you're trying to get a word in here.

MS. NUSGART: I was going to say that probably just simply the instructions for use, if you're just talking about what is the term, you know, patient insert means to you. When I would ask a number of different physicians and nurses about this was how do you use it and tell us how to do that. But that may be a little bit too simplistic. Again, it depends on the device, the users, et cetera, et cetera.

MR. CONNELL: Instructions for use is a very different thing for an MRI machine than a small device like a patient monitoring machine. It's just very different -- versus 20 pages.

DR. NELSON: And if I have a pacemaker implanted, I don't need to read the manual. My cardiologist has to.

MS. NUSGART: Maybe that's why the bottom line to all of this is that when you're probably going to be asking the question later, who should these devices -- or what type of devices should be in this type of repository? And maybe it's not the entire universe of medical devices. Maybe it's simply, if as FDA you want to be able to ensure that the patients, the caregivers that really understand how to use these devices effectively, maybe they should be the devices in the home.

MS. MENDELSON: If there aren't immediate questions to that, that was my next question.

MR. BINION: Yeah, just one follow-on comment. And what, you know, Stuart identified as an opportunity is obviously a complex challenge here to create even what at first glance is a simple concept for device labeling.

Going forward, I think the only way we're going to solve this is, as has already been mentioned today and advocated, significant further dialogue between the manufacturers and FDA as to what's going to be required. And I'm not saying anything we haven't already heard here, but I think the realistic answer is that it's going to vary by device type and by the audience that needs the access to the appropriate information at the appropriate time.

MS. MENDELSON: Thanks, all of you. I think you should like this question better. We've heard a lot this morning about -- and all day -- about there being hundreds and hundreds of thousands of devices out there. If there were some sort of database repository collection of the labeling, what could we exclude? Or if you'd like to answer that from the other way around, what should we include? Either way is acceptable.

Jeff, start us off and we'll go down the line.

MR. SECUNDA: Well, I'm going to start off from what Marcia said, and I think we really have to look at only those devices that are used in the home. There may be, you know, others who have needs of device labeling, but they're in a position -- whether they're professional or otherwise, they have other resources. They have hopefully a more sophisticated relationship with the manufacturers and with the devices and with the information.

But I think we really have to limit this whole effort. Whether it be a portal to the information or whether an actual repository run by the FDA, we really have to talk about home care devices, and because those are the people that have it at home and don't have the information, and I think that's where we should be going with this.

MS. MENDELSON: May I just ask you a follow-up on that? What about implanted devices that are clearly used in the home but aren't really used? Like a hip or a heart valve.

MS. WINSTEL: I would like to echo completely what Jeff said and to follow up what you said, the question on the implants. I use the screws in my ankle every day, but I don't interact with them. So I think that there is something about the word interaction, because when we're talking about use, it is about somebody who is interacting with a device, whether that is the patient, the family caregiver, or the home health aide. Somebody is interacting with the device in a non-clinical setting.

And I just want to be very clear for the record that when we say home, we don't specifically mean the house, the apartment, or whatever. We mean in a non-clinical setting. Anybody who interacts with the device in a non-clinical setting, who no longer for any reason has access to the original paper labeling and packaging, I believe, should have access to that original information so that we can ensure safe use.

MR. MOSKOWITZ: I'll make a quick point on how we do interact with implants. And certainly you might not, you know, be interacting with screws in your ankle at home, but if you had to go in for another procedure, you'd be interacting with them, and that information becomes important. If they're mixing and matching components and you can't switch up the alloys with the stainless steel if you're switching out a plate, if you're going in for an imaging procedure, some of this information becomes relevant again for certain devices.

So, yeah, you're with professionals hopefully at that point that are doing those procedures. So you yourself might not be making decisions, but -- and they might be needing to do this in an emergency situation where they'd be looking for a quick reference.

MR. KILANDER: Just to add to that point. I'm sorry if I jumped in line. Just to add to that point for -- I think it was Aaron's point. A lot of devices that are implants do require pretty extensive monitoring and follow-up that will not be necessarily directly under the view of a physician or caregiver days, weeks, months, and years after that device is implanted. So having information available online to patients to recognize that maybe that pain in my chest is something I should go see my physician about is pretty important as well, I think.

MS. MENDELSON: Elizabeth and then Pat.

MS. GEORGE: Two things regarding that. First I think, again, something like that, that Chris just spoke about, I would hope that that device would've had, as part of the requirement of labeling when they got their product approved, patient information that would be supplied to them and then that would be what would be the differentiated labeling that would be public.

And I just thought of -- and I should've thought of this earlier, but another venue as to how information can be conveyed is, is anybody who's ever had to use an automatic external defibrillator, you don't have the labeling with you. It talks to you and tells you how to use the product. So it walks you through and it actually -- at least ours, and I'm assuming all the others do as well, is that it actually acknowledges when you're smart enough to know how to use it, that it skips over walking through those steps so that there's an intelligence built into it as well.

MS. SHRADER: I just wanted to add that I can't readily think of an example of a device that should be totally excluded from publicly available labeling, but I do believe that there is information -- and reference has been made to this. There's a wealth of information available about many kinds of devices, but there are pieces of information that may be inappropriate for specific audiences.

For example, you know, if you send a patient home with a device, you want them to be able to use that device safely and effectively, you want them to be able to maintain it, but you may not want them to be able to make adjustments on the device. The adjustment might be the responsibility of a medical professional.

So I think you've got to be very careful in thinking about what you want to make publicly available, to be sure that you're also thinking about those things that you want available but you may want available to a limited audience. So I think, you know, the important concept there is people need to have the information necessary to use and maintain the device. You should take care to make sure that they do not have information that they could use to deliberately injure themselves with the device.

MS. BENNEWITH: Yes, to add to Patricia's point, you don't want patients to go to the website in place of reaching out to a professional, of course. So I want to make that clear.

MS. MENDELSON: Thank you. Does anyone else have a comment on this?

MR. KILANDER: I did have one other point. The whole workshop is really based around the 510(k) program, but obviously we've been talking about devices that run the gamut from Class I to Class III. And I believe there are a number of Class I devices which are exempt from labeling requirements, for which I don't believe we should have a requirement to post labeling information or create labeling information where it doesn't currently exist. Those are professionally used prescription-only devices that patients typically do not interact with but are critical in surgeries and in serving patients.

MR. TALCOTT: Hi, Tim Talcott with Smiths Medical.

First of all, I want say I've really enjoyed this conference here today, public meeting. It's one of the best I've been too, so I really appreciate it. I wasn't sure what I was in store for. My mind has been spinning ever since I've been here, picking up things that I've got to think about later to send my written comments in later.

This seems like a classic risk management approach we need to take. I've been thinking about the good things that come up about this labeling and the bad things. Think about band-aids. Purposely, I don't care if I have band-aids labeling on the Internet. I can go down to the store today and buy some more of them and I have whatever labeling is with the product.

We mentioned about home care. One of our products, tracheostomy tubes, I know they're used in the home. We put that in our labeling, and I'd like talk to you later about maybe how we can improve that.

But that's a product also that if a customer has a tracheostomy tube -- I was talking to Marcia at lunch about it -- that if they have one of competitors, that's what they have and they go to the Internet and they see on eBay they could buy one cheaper of our product, so they go out and they buy our product because they can get the labeling offline and they put it, but guess what? It doesn't fit because it's not made for them, but they don't know it.

So really there's where labeling causes a problem because they have access to it. So we've got to go back to risk management to say what we do and don't put publicly available.

And as I hear this, I'm saying, oh, the labeling for my tracheostomy tube, I wouldn't want to make that readily available. In addition, if they have my tracheostomy tube in place, do they know that it's mine? If they don't have the labeling anymore, there is some labeling on the flanges, but are they really going to find the right one? Or could they go to another one of the Smiths Medical tracheostomy tubes?

We have one that's made in Gary, Indiana, called a Bivona, which is made to be inflated with water. If you go to our others, they're inflated with air. If you inflate the Bivona tube with air, it's going to leak, and now you're not going to have a seal anymore, so you have an emergency situation.

So labeling is great to be available, but it has to be the right labeling. And so I urge us to take this through risk management and see where we go from there. Thanks.

MS. MENDELSON: Thank you. Any other comments from the floor?

(No response.)

MS. MENDELSON: From the Panel?

(No response.)

MS. MENDELSON: All right, our next question. Do you need like a mid-game stretch or something, or you're okay? All right.

So looking at both the idea of a repository -- and not the idea of a repository, just labeling in general. I talked earlier today about the circumstances under which patient or consumer labeling is necessary. But I wonder if we could talk just briefly about what types of devices, in your opinions, actually need labeling that's directed to the consumer, to the patient, to the caregiver.

Start us off.

MR. KILANDER: Well, the gentleman from Smiths stole my thunder here. I was going to talk about risk management in this section, and I think that's critical to any of the discussion that we're having from Class I to Class III devices. Obviously, with tongue depressors and band-aids, the amount of labeling is much less significant than with MRI machines and AAA stents, which I have an example of here, by the way.

So from my point of view, I think it's important to really look back to the risk analysis that's conducted as part of the design and labeling development of the product and really determine all the many different forms that labeling may need to take.

We've heard things like videos. We've heard things like devices that talk to users. We've heard about training. We've heard about online resources, print resources and so on, but also the audiences and who are the different users of that information, not only physicians and caregivers, but patients, in making decisions, patients with varying levels of background knowledge and information, trying to gain more additional information about what device is right for them.

So from my point of view, certainly anything that the FDA publishes in terms of what labeling would be required should be very much based upon risk and the different factors that accompany risk for those different audiences and different device types.

MS. MENDELSON: Does anyone want to get a little more in the weeds and give us some specific types of devices where a line might be drawn? Surely not everything needs patient labeling.

MR. SECUNDA: Well, you know, we just got answer. We need to do risk analysis to see what -- we're not going to be able -- certainly now we're not going to be able to make up a list of devices that need patient labeling. It's a process, and the risk analysis is the process that should be used.

MR. KILANDER: But I could go through a little bit of the example that I was going to close with in my closing remarks. But in preparing for this, thinking about labeling, I pulled one of Cook's more complex devices, which is a AAA stent. It's for treating abdominal aortic aneurysms.

There's a 200-page booklet that comes with it. It goes to physicians. It's got a lot of information on clinical trials, patient selection, background information. It's in 14 languages. It has 57 diagrams, 35 charts and tables. There's a lot of information in here.

But there's also a patient booklet so the patient can understand what is my condition, why am I the right patient for this kind of treatment as opposed to another treatment, and hopefully there's information that we can provide them through not only a booklet like this but online or being able to look at some of the physician references so that they can make an appropriate risk/benefit decision with their care provider about what the right treatment is for them and maybe what the right device is, not only our device but our competitors' devices, and make the right decision for them.

MS. MENDELSON: Any other comments on this?

(No response.)

MS. MENDELSON: Let's speed through this one. Sticking with content, we've heard several speakers today talk about medical devices don't have defined content elements. If there were structured product labeling today, we don't right now, today, have the elements that would go into the structured product labeling.

If we think about the labeling for professionals or for patients who are receiving prescription devices or for patients or consumers who are selecting their own devices at the pharmacy, what are those common elements? What's the most important content that needs to be included in that labeling?

MS. GEORGE: There's a couple of obvious ones. There's the warnings, precautions, intended use, basic setup, and then methods of how to use the device. And I think those are common to everything, no matter how complex the item is. But how complex that gets does depend on the user and the methodology, whether it's pictorial or whether it's, you know, written in very high-level language.

And then, depending on the product, there may be a need to have both similar to what Chris described, there's the 200-page for the professional on the what, the how, the where to do, and then there's something for the patient that makes it simple to understand why they're getting the item.

MR. CONNELL: And I think it's also dependent on which type of professional we're talking about. I mean, certainly if you take a medical imaging machine and you have a prescriber, you probably have an overseeing physician in a different location, you have an operator, a tech, you have several professionals throughout the process, each of which needs a different set of information. And so trying to drill that down is, I think, important if we're going to actually provide patient benefit in that.


MS. NUSGART: This may be a little bit different than you might be thinking about, but when I was asking a number of different physicians, what was interesting is that they were saying that what we don't know is what the patient actually is using.

So when they come into our office or in an emergency room or things like that, for instance, if you do have an implant, we just want to make sure that the patient has a card or something in their wallet and maybe it can tell you what kind of screws that you have, whether it was aluminum or whatever. But that was always very important to know that a patient does have this type of implantable device, you know, in them, so that they would be able to treat them accordingly, or at least having that type of knowledge.

MR. BINION: Yeah, and I'll second that. That's one of the top things that we hear is that doctors receive questions about a device, but they're not specific enough about which device it is.

So when we talk about labeling, even if it's a non-implantable device and it's big enough, it needs to be properly labeled so it can be identified. And you talk about getting photographs, you know, for verification; is this the device that you want to find information of? This is a very important component, even before you talk about putting the information online. If a person can't get to the right information, then it's not too useful.

MS. MENDELSON: Anyone else on the Panel have a comment on this?

MS. WINSTEL: I would say that one of the most important pieces of the content needs to be where do I turn? And that answer for where do I turn might depend on what the problem is. For some things you do go to the manufacturer. For others you do have to go to your healthcare provider. But I think that that information in any product or device that interacts with a patient or family caregiver is key.

MS. MENDELSON: Does anyone from the floor have something to add to this?

(No response.)

MS. MENDELSON: All right, photographs. Joyce spoke this morning about the portion of the 510(k) implementation program that has proposed putting photographs of all 510(k) devices and PMA devices in a publicly accessible database.

So the question is should photographs be made available to the public? Why will this be helpful? Why might this not be helpful? Who will use them? How could it be implemented? How should we do it? How should we implement it? I wonder if anybody is willing to speak to any piece of this.

Do you want to start us off?

MS. BENNEWITH: Yes, I'll raise a comment for this question. Following up on what Jeff had said earlier, we need to think about what the reason is for including photographs in this database.

I have an example of medical gas cylinders. There are all kinds of medical gases that are used in the healthcare sector, from oxygen to nitrogen and a lot of others. There's been a lot of discussion about color coding for different cylinders in the hospital setting, and you can go into a lot more detail about the intricacies of that and the labeling of those types of cylinders. But there has been some discussion about different colors for different gases, and that's another whole discussion. You know, the government has different color coding to military organizations, and internationally, they have different colors.

So, anyway, to get to my point, simply looking at a picture of a color-coded cylinder doesn't really tell you anything about how to use the device or what the device is used for and who is using the device. For example, with cylinders for oxygen and nitrogen, there have been many Federal Register notices about this, where gases have been used incorrectly in hospital settings.

So for a patient that needs oxygen, a nurse will come in quickly, look at, let's say, a green cylinder, and oh, it's not working, let's switch the tubes, grab the tube and switch it and put a nitrogen tube on this supposedly oxygen cylinder and give the patient nitrogen instead of oxygen.

That is not because -- I mean, it's a visual. You know, you can see the coloring of it, but the use of it, you know, you're not supposed to be able to -- well, this was decided later. You're not supposed be able to just pull the part, the tubing, and put it wherever you want. So what happened afterwards, after a lot of those instances, the locking device is brazed, it's sealed, so you cannot interchange the tubing. But looking at a picture of this doesn't really tell you how to use the device. So that's just my example for the photograph question.

MS. MENDELSON: Thank you. Elizabeth.

MS. GEORGE: Repeating a few examples from before, I mentioned the CD-ROMs. I don't think you could tell the difference between software that's for radiation therapy planning or software that's for a patient monitor or software that's for an MRI machine or any of the differences. So that's one that I don't see a photograph as being very valuable.

And then if I think of CT machines or MR or, you know, even ultrasound machines, right now, across most of the manufacturers, sometimes on quick glance it's hard to tell the difference between the manufacturers' products. And then if you look at a CT machine, for example, you could have a 6-slice up to a 512-slice machine, and they look identical. So a photograph really is not going to differentiate that much on many of those kinds of equipment.

DR. NELSON: On the other hand, sometimes a picture is really, really helpful in identifying something. Maybe it's not necessary for a CT or an MRI, but you know, sometimes it's very, very helpful to be able to know what it looks like, a different shape and which model or whatever.

MR. SECUNDA: And I'm not trying to be flip, but I really don't know in what situation it might be helpful or it might be nice to know, but in what situation would a photograph really give you important information so that you can make a decision about something? And, honestly, I'm not being flip. I just can't think of anything.

DR. NELSON: How many Accu-Chek glucometers are there out there of various sundry and makes, right? And until I look at one, I don't -- you know, I can see the words there, and that doesn't tell me which sticks I get to go with which glucometer. Then I see the picture and I say, ah, this is the right one. Or whatever.

So this is the kind of stuff, and it's just identify the model, identify what's -- you know, what is there and how it works with other things. I think that's quite useful for some things. Other things, it's not going to be very useful.


MS. SHRADER: I think that's actually a really good answer. It's difficult to answer Question 7 unless you say, first of all, who would want a picture of the product, and secondly, what are they going to use that picture for?

Most manufacturers, I mean, we're all pretty proud of our products, so we do put pictures of our products on our website. I don't know that we've ever really looked into, you know, who looks at that picture and what do they do with that picture.

And I'm in agreement with you. You know, it can be very helpful if you're trying to distinguish one company's pacemaker from another, provided that you're looking at the side of it that's got the company's name written on it and that the company has its name written on it. That can be valuable. But first you have to answer the question, who's going to use this photograph and what are they going to use it for? And then I think you can go back and say, well, does a photograph need to be publicly available?

MR. KILANDER: Well, as with the other topics we've been discussing today, there's clearly not a one-size-fits-all solution. But from a patient point of view, certainly there is a lot of value in being able to point a patient to a picture and say this is what your device will look like when you go onto the procedure. This is how it's going to fit in your ankle, in your knee, in your aorta, or however that's going to be, where that device is going to be used. So having a reasonably reliable resource available for patients, we believe, is important.

MS. WINSTEL: Just very quickly to augment what everyone was saying. It's not so much that I think a photo is a decision tool as it is for confirmation and illustration.

MR. KILANDER: The other thing I'll add, which echoes, Pat, your point, is that I would challenge any manufacturer to effectively sell and market your devices without pictures available. So certainly the information is there. It's just how it's presented and where it's presented.

One thing I would add under the third sub-bullet here is that if they are needed for a particular device, I would certainly caution against requiring unique pictures for every model and make of a device, but rather for a brand or a type of device. If my device varies only by one millimeter in diameter from the next one that I sell, I shouldn't put up unique pictures for each one of those.

MS. MENDELSON: Part of FDA's assumption was that posting illustrations or photographs would be helpful to industry. Most of the Panel here is industry. Would this be helpful to you in determining your substantial equivalence or in determining your predicate?

MS. GEORGE: I don't think so because I think most of us make use of Google to find out who are competitors are or already know. So we already have -- we're using FOI, already get their 510(k)'s. So we already have lots of other tools available to us, and so I think this specific database would just -- it's probably the last place we'd go to because we'd go to other places first. We'd, you know, go to the companies' websites directly to get the photos.

You know, again, I think my answer earlier to this question was really focused on this separate database. Clearly, we have lots of pictures of our products, and as Pat and Chris said, I think all companies are very proud of what our products look like. So that's what we do is we promote them with pictures.

MR. KILANDER: I second the point on an FDA website being a good source for predicate information. We go to the manufacturer's website first and foremost, if we can get information from there. The only caveat would be for those devices for which we cannot find any company in business anymore that holds that 510(k) or for which there is no clear traceability to the new owner.

So along the lines of the other recommendations that were in the 510(k) series, having the traceability from manufacturer to manufacturer would certainly help that and eliminate the need to have the pictures just for the regulatory purposes.

MR. BINION: Yeah, just to follow up. I think, as I recall, the original recommendation is part of the 510(k) reports. To the extent that potentially making photographs available to FDA during -- you know, as part of the 510(k) review process, I think is, you know, a situation that's very distinct from what's being proposed here.

In terms of what's available to the public, to echo what Pat said, I think that, you know, the question of what's the value, how would that information be used, you know, needs to inform the question of whether they're available.

Finally, on the point as to whether this would -- a publicly available photo would represent a significant resource to industry in planning or making 510(k) filing decisions, I've polled, you know, all of my colleagues internally at BD, and the answer, you know, on that is no, in terms of any significantly additional value, you know, to this resource.

DR. NELSON: I wanted to comment about the use of information. I think sometimes -- you know, I'm going to diverge for a minute. Software. We know software is successful when it's adapted for use for what it was designed to do.

These two guys up in Boston decided to write a program to help them with their accounting. That became spreadsheets. We use spreadsheets for all sorts of things today.

The whole idea that we can anticipate all the uses that something that might be made of data is really hard to -- it's really hard to conceive of that we know exactly everything that's going to be done with it or that we can even anticipate it. You know, I don't have a dog in this fight, but you know, I just wanted to point that out, that sometimes looking ahead, you don't see how and when and why, but you know, sometimes it surprises you.

MS. MENDELSON: I heard earlier that, for labeling, only certain devices need certain types of labeling. I'm wondering if there are only certain types of medical devices that need pictures in some sort of repository.

You have your hand raised to answer the previous question, but to open it up to everyone, you know, is there again a line that can be drawn between devices that should have a picture in some sort of repository versus devices that really don't need it? And I will fully acknowledge that probably CDs of software or something could be right up in that category of not needing it.

MR. MOSKOWITZ: Yeah, I just wanted to reiterate the point of how to use images, and certainly it sounds that people that are outside of industry, which, I guess, aren't too interested in this, but individuals want to know which device they have.

To verify it's accurate, you know, as you move into an area where you could buy a variety of things, including medical devices, off the Internet, you want to be sure you're buying the authentic product and this could be a good resource for that as well, making sure that you have the right thing.

And then, even if there is a small change in manufacturing lines and you want to find out about that, it helps to have an up-to-date photograph to reference what you bought is what you have, and if you're going to find more information about that, that you know exactly what it is.

MS. MENDELSON: Does anyone from the floor have anything to add to this discussion?

(No response.)

MS. MENDELSON: And any of our panelists?

(No response.)

MS. MENDELSON: All right. You know, let's go hypothetical here for a minute, and if there was a labeling repository and if it were implemented and if it were required at some level, FDA would need to somehow receive whatever portion of the labeling that would be coming in to us.

So many of you already use some of the existing gateway systems that FDA has. Would you suggest that the labeling come in through a similar electronic gateway or a different way? And if it's a different way, what's worked in the past?

MS. SHRADER: Well, first I should say I've been at Medtronic for four days now, and I did meet yesterday with the folks who have been working in this area for a long time and asked them the question, and they said, please, yes, to be submitting information to the FDA for a labeling repository, use the electronic gateway. It works. We all know how to use it and, you know, minimizing any duplication would be helpful to us.

MR. SECUNDA: Well, I think -- sorry, I didn't raise my hand. I cut in front again. I think the bigger question is SPL. And there are lots of things that go through the gateway, including PDFs. So I think somebody from the audience raised the question as to whether the labeling as a scan in the PDF form would be adequate. And let me add to that.

Another part of the question is on the photographs, as to whether -- you know, there's lots of technical issues about photographs and the usefulness of them and what Aaron was talking about, I think, in some cases was imaging. Not the photograph of the product, but a medical image. That, I think, should be clarified if that's what FDA is thinking about. Sorry if I asked too many questions.

MS. GEORGE: I want to concur with both Pat and Jeff. I think that the electronic gateway does work. It's a system that's already in place. Many manufacturers are using it. I know that we have some challenges sometimes on the MDR side. I know on the -- we use it prevalently for 2579 forms for certifiable components for X-ray. It gives us feedback so that we know it really got there, which I think is a positive thing.

I think also, as Jeff said, I think if there's going to be a prescribed methodology of what -- if it's SPL, PDF, whatever format, that needs to be very clear so that that's in the system. And I think we need to understand whether it will be capable of the large size, depending on what we decide ends up being in the labeling, the physical -- if there are any constraints to physical size of the items being sent. And then, whether it's just like MDR or the 2579, there's opportunity to send single or bundled. So those types of things need to be taken into consideration as well.

MR. KILANDER: I think there's some important considerations around SPL versus -- and I'm afraid I'm really just learning some of those terms today, so I'm not an expert in this area, but define formats such SPL or XML versus PDF formats. And I certainly would encourage the Agency to consider multiple means of receiving that information.

From my point of view, I held up a 200-page IFU here just a little while ago that does include several images and tables and charts and graphs and keeping all of that together in anything but a PDF format, I think, would be somewhat challenging. And also if we have that information available in multiple languages, then others can access that, not only from the United States but from anywhere around the world and get the labeling information in one spot.

MS. GEORGE: A home care would encourage the Agency to look at the systems that are already in place and use those. And also we would like to get some information from the home-use labeling pilot that Agency is doing.

MS. MENDELSON: Does anyone in the audience have experience with the electronic gateways or other ways of entering information to the Agency, with something to contribute?

MR. TALCOTT: One question for the Panel. As I mentioned earlier this morning, I have had tremendous problems with the drug gateway and doing the SPL listings on kits. It has been 18 months of misery.

I just have a question. Is this gateway for a device is different than drugs? If it is, hooray.

MS. MENDELSON: Is that the same gateway? Mary is telling me it's the same gateway.

MR. TALCOTT: Let me tell you what I've experienced with the gateway for drugs. They came out with it, and the first problem I have is my firewall through AT&T won't work. And so we finally get that resolved, start working in it, and they have a validator where you have 35 problems. You get all of those problems fixed, you send it into FDA, and they say you still have problems.

And each one of these applications, you fill out forms, it takes at least an hour and a half, and in our case it takes eight times that longer. So you finally get it fixed and you send it in, and you get these letters back -- you mentioned that you thought it might be the same system -- then you get one back says you still have problems. And after nine months we finally get one through.

Then they changed the form and it took -- and if anyone knows, I think it took from September up until last month to get it working again. So we started doing it again, and then they changed the process again, so we've got to go back through firewalls twice. You finally get it to work on a Friday, that's validated, and then on Monday you come back in and all of a sudden you've got nine errors in the same system you just had.

So if this is the same system, then it doesn't work for everyone, and I'm not sure why, but I would love to know and in order to make it work for the drugs and devices. Thank you very much.

MS. GEORGE: I'd worry if it's not going to work because MDR electronic reporting is coming soon, right? I mean very soon, and it's going to be mandatory. So if it's not working, we better figure what those problems are quick.

MR. TALCOTT: That's one of the things that might be somewhat of a different system. I have one more comment, too, that I meant to add.

My first question today was about cost and the value. With the estimate of approximately one and a half hours for these submissions, which I can agree that it would at least take that long, we have roughly 20,000 SKUs, which means that's how many different labelings we'd have to submit. That's 30,000 hours, and that would be 15 people full time. Our kits are approximately the same number. We'd end up with another 15 people. Just from my company, we'd have 30 people that would have to be hired full time because labeling can change on an annual basis because of risk management, which drives labeling changes.

So you're talking about, for one company, which I'm not sure, say $2 billion in annual sales -- don't write that down because I don't know if it's right or wrong, but it's a good estimate. If that's what you have for that size company, and the number of companies that we have in the U.S. and around the world, this can be very cost ineffective.

The comment made by Lisa, having a link to the company's site, seemed like a very good solution because it would also deal with what we may face in other countries and we need to face about other countries at the same time because we're a global market. What are other countries going to be expecting? And if we did it at the company's site, we can control it. But imagine doing this to 150 different countries giving you their labeling into their format. How are we going to do that? But we could do it if we kept it on our site. Thank you.

MS. MENDELSON: Thank you for that perspective.

I'm going to go off script for just one second here and ask you a final question that I don't have a slide for, and that is, if you think of labeling, electronic labeling, labeling repositories, content of labeling, is there anything that FDA can be providing you that it isn't providing you now? I'll ask our Panel members. Is there a way we can help you that we're not helping now?

MR. KILANDER: I'm not sure if I understand that. Helping us do what?

MS. MENDELSON: Develop the labeling, think about the content, apply it to the correct audience, submit it to an electronic repository, if it should come to that.

MR. KILANDER: Well, I think it's important for the FDA to recognize that the medical industry is a global business and that we do business around the world and every -- just about every regulatory body has some different perspective on what goes on labeling. And certainly some of the things that we've seen that have been very challenging are the use of symbols, the ability to use common terminology in what will go in an IFU or how information is submitted.

We have databases that are springing up around the world, similar to the UDI database, the different regulators are asking us to input information into in order to access their markets.

And so from an industry point of view, being able to address multiple regulatory needs with the same solution is critical. Otherwise we are building unique solutions for each unique set of regulatory requirements, and those are only driving up the cost of healthcare and making it more difficult for us to serve patients around the world. It is a global business, and we do sell products everywhere we can. So certainly recognizing that the FDA is not the only regulatory body around the world dealing with these questions, I think, is key.

MS. MENDELSON: Thank you.

MR. SECUNDA: Could I just follow up on what Chris said, the two excellent points? First, I just wanted to mention that there is an organization, the Global Harmonization Task Force, and that is -- its goal is to harmonize various regulatory matters across the globe for the regulators. This is a very active project now with unique device identification, and the hope is that there'll be one format both for the structure of that identifier as well as the methodology for transmitting the information to the UDI databases.

The other point, again, you know, Chris made, and it's very important and I'm sorry I didn't think of saying it, is you want to know what FDA can do to help labeling for companies, that is, you can accept international labels. Because right now companies, other than for in vitro diagnostic devices, are not able to use a label on their product unless it's accompanied by English text, which kind of defeats the purpose of using the label.

So I would strongly encourage FDA -- I know that you're looking at it, but I would strongly encourage FDA to accept the international standards for symbols.

MS. MENDELSON: Thank you.

MS. GEORGE: I'd like to echo all of that, what has been said. I think the symbols, using standards, I know the FDA is very active in many of the standards organizations, so continuing to focus on that. Terminology, I think, has got to be harmonized. The definition of a manufacturer is different in different regions of the world. And then even what is a medical device, I think, as GHTF, that'll be really interesting to see because I know Philips, we have a product that in the U.S. it's Class II, in Europe it's Class I, and in Asia-Pacific it's not a medical device.

So we have very different ways of having to deal with the different regions, and just as Chris said, most of us, most industries these days, even if they start off as a local U.S. only, they either grow on their own or they get acquired by one of the big guys. So as I said, we acquired 27 companies in the last seven years, so those companies all went from being single regions, single companies, to now global.

MS. MENDELSON: Steve, do you have a comment?

MR. BINION: Yeah, just a follow-on comment. I think that the question of an electronic labeling repository submission process gateway really would be best addressed as part of an overall establishment of a true electronic submission process for premarket notification, you know, preapproval submissions for devices, because I think one of the things we're going to be faced with is developing a one-off solution here for an electronic repository only of labeling, while we're still struggling to create a seamless submission process that's supported by electronic submissions.

MS. NUSGART: I think the fact that you're allowing us to be able to be here today and allowing us to provide input is going to be extremely helpful in terms of not only what you're doing today but also with the UDI process that is going on and what Mary Brady is doing in terms of the guidance document for home use. I mean, having our input on it and working with having a partnership of us working with you every step of the way, I think, is immensely helpful in keeping that communication going.

MS. SHRADER: I'll support everything that's been said here so far, both in terms of globalization and in terms of getting stakeholder input. And I can tell that as an industry representative, I very much appreciated hearing from other stakeholders and understanding some of the specific needs that are out there that we need to be thinking about.

I'll also compliment the FDA. The sum of Medtronic's businesses do make products that are for home use or over-the-counter products, and I know that they do interact with the Agency and with some of the experts in the Agency to get feedback on the labeling that we're developing, to make sure that it makes sense, that it's readable, that it can be understood at the right level, and to benefit from some of the knowledge that FDA may have that the companies may not.

So I would certainly strongly encourage FDA to continue working with companies and helping us to assure that the information that's needed is getting to the right people and is getting there in a form and a format that they can understand.

MS. MENDELSON: Well, I want to very much thank all of the panelists for agreeing to sit up here today. Many of you found out about this only a day or two ago, and you've helped us really have a good spirited conversation on this.

In the last couple of minutes that we have our Panel sitting here, let's just go down the line. If you have any last-minute comments, any wrap-up comments, concluding remarks that you'd like to make to FDA and to the group here, we'd like to invite you to do that right now. And we went from that side last time, so Marcia, do you want to start us this time?

MS. NUSGART: Thank you for allowing us to be able to here, and we'll be submitting comments also, so thank you.

MR. MOSKOWITZ: I just want to thank you for this opportunity as well. And I think I've covered everything already, but just to reiterate, you know, I'm grateful that this is a conversation that we're having. It's something that we've been working on, on our own, which is getting information from the people that are looking for it. Chiefly among them is keeping that -- letting people know which device they have and then directing them to the right information. I think that sort of is the key of what we've been talking about today.

MS. SHRADER: I really do appreciate the opportunity both to speak and to hear what others have had to say. On the part of, certainly, Medtronic, and I think this is true of most manufacturers, if not all, we really do want to try to make sure that people have the information that they need to use products safely and effectively.

You know, part of our design process for products includes looking at the information that we're going to provide on the product, you know, how we're going to get it to people. And I think we've heard some really good examples today.

You know, this is a much more complex issue on the medical device side, I think, than it is on the pharma side. We need to appreciate the variety of audiences that are looking for information and the different ways that they might use that information, they may want to get that information.

I do think that it's most important that we think carefully about the whole safety aspect. We want to get people the information that they need and can use. We do want to be careful that we're not giving them information that might enable them to do something to a device that would cause that device not to work well or might cause harm to them.

In talking about the complexity, I have to admit to having kind of laughed really a little bit at 22,000 pieces of information on drugs in the National Library of Medicine, with perhaps nine times that amount archived. That doesn't begin to describe the amount of information that just one single company has on its products. So there's a vast amount of material available, and in thinking about developing repositories and keeping information up to date, I just want to be really sure that no one underestimates the task that's involved at all. I mean, we try to be as timely as we possibly can and make sure that you understand the iterations that product labeling may go through during the life cycle of a device as compared to a drug.

On the drug side, you know, you'll be providing new information about adverse events. You may be providing new information about patient populations. On the device, we're continuously iterating these devices, and there are new bits and pieces of information each time we do that, in addition to the life cycle information on versions one, versions two, versions three.

And to follow on that, so I think it is really important to prioritize what are the greatest needs for information. I do feel that making sure that we have accurate and complete information on home-use products and over-the-counter products is probably a top priority that FDA should be focused on. And I think that we also, as someone this morning noted, we need to also take into account the cost to the healthcare system, of trying to be overly comprehensive in providing information. So it's important to get the right information out there and get out there the information that can be used, but not to go overboard with it. Thanks.

MR. KILANDER: I want to echo a couple of things that Pat said with respect to version control and really being able to link devices to different labeling and ensuring that what you have available is definitive. And also in terms of prioritization, clearly there's a priority on home-use devices, people who are not professionals using devices, but also looking beyond that, certainly, to other device categories.

I would like to offer a few suggestions to the Agency as well. I think one of those is take a good look, if it has not already been done, a systematic look at what manufacturers do post today on their websites, what kind of information is available, from IFUs to videos and all the different means with which manufacturers try to communicate with customers, with patients, with any stakeholders involved in healthcare.

And secondly, I think, is take a good, hard look at one change in the delivery, which could be e-only labeling, labeling that is only delivered electronically, not in hardcopy or not with a product. Certainly not every device is going to fit that category. Home-use devices, clearly, there should be more information than a company and that device. But there also can be products where part or all of the labeling may be best suited to be delivered only electronically. And certainly that's an incentive for industry, as it reduces the amount of paper waste and shipping costs associated with getting products around the world.

In conclusion, Cook certainly feels very strongly about providing patients with the information that they need to make decisions on their healthcare. Even if those devices may not be anything that they ever think about or realize was used, we believe that patients should have the information that they need to be able to make good decisions, and that involves not only patient-focused materials but access to what the physicians see.

It's very clear these days that patients, which all of us are, certainly are going online, finding information and looking beyond the immediate information, when the risk is high or the condition is severe, to find out more information about what treatments are available, what options they have, and really trying to dig in and educate themselves as much as they can. And we believe it's our job to help patients do that in a way that gives them the information they need to have an intelligent discussion with their physician.

So certainly from our point of view, giving this information to patients, unless of course as you mentioned, Pat, it presents an immediate risk, it should certainly be available to patients.

MR. BINION: First off, I too want to thank FDA for the opportunity to participate in this discussion today. I've learned a lot and hopefully contributed something.

Clearly this is a complex, complicated issue. I think, you know, manufacturers, industry, and healthcare providers are all committed to ensuring and working diligently to provide the appropriate information to the various populations that need the information about medical devices. And I think the discussion we've had today, everything that's been shared, you know, is a great start towards looking more deeply into this issue and really making sure that we understand the needs to be met by the individual groups before we design the best solution to deliver the information to the folks who need it, when they need it.

MS. GEORGE: Like my colleagues, I want to thank the FDA for this opportunity, and I echo all of what they've said. But I think one of the things bottom line is, is the standard response, it depends, and I think we need to remember that one size does not fit all. And so I look forward to industry and FDA continuing the communication and the partnership going forward. Thank you.

DR. NELSON: Well, I'm the outsider here, and I'm not sure whether to thank the FDA for inviting me or not.


DR. NELSON: But it's actually been very interesting and very educational. I'm going to kind of put on my informatics hat for a while here and just say that, to me, where you stand right now is kind of like we need to -- you need to have -- first of all, I have to say any information that you provide, you really need to get it structured. It can't just be long pieces of text. You really need to have some structure put into it. That makes it process-able, reusable. Very important.

Define the common elements. Define what needs to be there. And don't think you're going to do the best the first time through. You're not going to do the best the first time through. What you're going to do is you're going to get something that maybe works, and then people will feed back and tell you, yes, this works, but we need to be able to accommodate this and accommodate that. And build on your experience. The most important aspect of it is to build on the experience.

I wanted to comment a little bit about version control. Version control is absolutely essential. I think one of things you're going to have to define in your elements is what is a label for a product that already exists? Or what's a label for a new product? And so that's going to include software versions as well as refined products and so forth. That is going to be a very essential part of defining the whole situation.

And lastly, one of the things I love about the world is the way that there's always the borderline cases, you know, and there's something that will get in DailyMed that I would call a device, but it's got a drug and a device, it's a combination type of thing. And they're very interesting, but these borderline cases often prove the really difficult part of deciding, you know, what belongs where, and I think that you need some good -- we need some good business rules between CDER and CDRH about where something is a device and where something is a drug. And, you know, how do you decide with combination products what you're going to do?

So with all of that, thanks.

MR. CONNELL: I would like to echo the thanks to FDA, and I know that I certainly appreciate the folks -- everyone up here appreciates the opportunity to be involved in the discussion before important decision points, and I think that's something that if we could keep doing moving forward on this initiative and other initiatives, that could be extremely helpful.

I think the single most important point I can make today on behalf of MITA is that FDA should move forward by focusing on consumers, on the patients, the caregivers, the healthcare professionals that you view as the intended audience for this repository. I personally think and my association thinks that in listening to those folks, there'll be different needs for different products, and I think that goes for both labeling and a photo repository. But I think that FDA should not so much listen to me on that but should listen to those groups and establish priorities that reflect what you hear there and then move forward accordingly.

Finally, I want to urge FDA to always be careful with any new initiative that pulls resources away from or creates new obstacles for the clearance process. It won't be successful in the end, so I just want to make sure that that's clear as well. Thank you.

MR. SECUNDA: Well, I think I've had enough opportunity to speak, so I'd like to focus on recognizing FDA's efforts in this area, especially the resources that were brought together for this particular meeting. It's been informative to me. I'm sorry if Stuart feels a little put upon, but I certainly learned a lot in terms of informatics. I use DailyMed, so I know about that.

But it's a lot to think about and I hope that the public that is here and especially FDA have listened carefully and will continue the dialogue in a deliberate fashion so that we can come up with a clear definition of the problem, a process that will lead us to a solution that is a solution to a real problem and one that will enhance the patient experience in the use of medical devices and the healthcare system.

MS. BENNEWITH: Okay, hello. Just some closing comments regarding -- again, thanks for inviting me to participate in this. I appreciate the Agency's home-use initiative and being part of this meeting.

I would like the Agency to consider the number of regulations that the healthcare sector already has to comply with, of course. I mean, it's for a good reason. CMS, FDA, the Department of Homeland Security, OSHA, DEA. Some of our companies are regulated by all of those agencies and that doesn't include state regulations as well. So you know, there are -- we all are in the business to make sure patients have the right products and good quality care, of course.

But I would remind the Agency to think about President Obama's memo that was released earlier in this year, regarding streamlining regulations. We support that initiative. There are a lot of instances where companies -- our member companies are providing the same information to different agencies. So I would encourage you to look at that so that there's not, you know, so much duplication and excessive burden without any additional value added.

So those are really my points. Of course we're not opposed to regulation. We support reasonable regulation, of course. And, you know, where appropriate, as an association we look at where we can strengthen those standards within the industry. So we work with CMS and we are working with the FDA on where we can improve that. So I just wanted to make those points. Thank you.

MS. WINSTEL: And a final comment. I'd like to say, Stuart, you're wrong, I'm the outsider here, being here as a nonprofit and representing a consumer perspective.

In addition to thanking the FDA, I want to thank the members of industry here represented here today. This is a wonderful opportunity for me to hear from you the challenges that you face that, frankly, from the consumer perspective, I would not have had had I not been here today. I want you to know that we really do respect the challenges that you face and remember also that the family caregiver is a member, a very proactive and important member of the healthcare team. Thank you all.

MS. MENDELSON: And thanks to all of you.

Mary's going to come up now and wrap up the day for us. And, Panel members, you can stay where you are if you'd like.

MS. WEICK-BRADY: Thank you. And I know that what I have to say here should go quickly so that everybody can leave as quickly as possible.

So I want to thank everyone for coming, taking the time out of your busy schedules and coming here and participating in this discussion today. I feel that FDA really does rely a lot on what outside stakeholders have to say, and I feel that this is a wonderful opportunity to hear, and trust me, we have heard you today, and I really appreciate it. So thank you all.

I think we gathered a lot of very constructive information, and we will take this back and look at how we are trying to move forward with having a labeling repository.

So summarizing in general, I think there were many things that we had been thinking that were confirmed. I'm not going to go through all of those. If you don't hear it coming out of my mouth right now, that's probably something we already thought about and said yeah, yeah, it's confirming it.

The cost is something that keeps coming up for doing this, and this is something that is essential that we have to know about. But I think we have to think of cost both ways. We have to think about the cost if we were to move ahead with something like this in a healthcare organization. We also have to think about the cost to the patient if we don't move ahead with something like this.

We want to make sure that the user gets what they need, and I've been hearing that over and over again. The user needs to get what they need. Not necessarily anything else, but what they need. They need to operate that device safely, so there are certain pieces of information that would be crucial for operating that device safely.

We need to focus on this from a risk management perspective for both the user and the environment in which it is going to be used. We also have to remember, and I think we're all in agreement on this, devices are very complex, varying from very simple to very difficult to use with a lot of parts and that there is no simple answer to this. So those are the general areas.

In the area of photographs, this is what I heard today, that photographs may be applicable for some devices, but not for all devices. So the instance depends on the user and the device and how they're using it in the environment in which they're using it. And perhaps photographs aren't the most necessary, but maybe line drawings or diagrams may be just as helpful to help somebody understand their product.

I also heard that scalability can be an issue. So if you're showing a photograph of a device, what are you really showing? Are you showing a very tiny device? Are you showing a very big device? Are they all looking the same?

I heard that photographs can be useful in four ways: as information gathering, for a decision-making tool, as confirmation of something that what you will have purchased is exactly that, and possibly as a comparison tool.

In the area of finding labeling, I have heard that direct access is the key. You want to be able to find that information immediately, and that it is also need based. We keep saying it depends, it depends. So it depends on the user. It would be need based for finding that information.

Having a repository could be a limited number of devices, mostly for consumers or certain audiences. Here I would say it would include active implants. Not necessarily the inactive implants, but active implants, especially those like aneurysm clip that could come apart if you walk through a certain security device; that in the area of home use, that some devices are going there whether they're labeled for home use or not, and that possibly this labeling repository would handle anything that might be migrating into the home as well.

And here I would think about certain wound care devices. I'm not picking on anybody here today, but some are labeled for home use and some are not, but most all of them are going into the home. Or trach tubes. You don't necessarily label those for home use. There are many people in the home that are using trach tubes.

So just thinking of that or taking a labeling repository and starting on a very small scale and moving to much broader scale maybe later on, possibly looking at just PMA devices or home-use devices or something on a smaller scale and then eventually, possibly moving to a broader scale.

I also heard something new. When we were discussing options this morning, one thing we had talked about was doing nothing or is there anything else you might think of having? And I heard the term of a portal that takes you to the right page on the manufacturer's website. Not necessarily on the FDA website, but maybe you'll go to FDA to go to that portal and then you put in some keywords, and it takes you directly to that patient information or that user instruction on the manufacturer's website, which would then have a new responsibility on the manufacturer to keep that information on their website and keep it up to date.

In the area of package inserts, I was a little disappointed here, folks. I didn't hear a lot. I heard a lot of, well, yeah, it needs to be there, but I didn't hear a lot of what really could be in a package insert, how would we want to define that. So I feel the onus is kind of back on FDA to try to figure out what we would want in a package insert.

I did hear that it would be the direct packaging of the device. I did hear one person say instructions for use, which that is now going down the track that we're looking for. You know, what would be in a package insert? Instructions for use? Yes. Very broad. However, we had devices that are very broad. So if you have instructions for use for your one complicated piece of equipment versus a simpler piece of equipment, that would be part of the package insert.

I heard that patient information should be part of a package insert and that there might be different media for different types of audiences that would be used as a package insert. And, finally I did hear that there should be contact information, whether it's the healthcare professional or the manufacturer, but that should be in the package insert.

And, finally, in the area of using a gateway, I did hear that the FDA gateway would probably be the way to go because it's being used in other ways, and I'm very sorry that there are problems with the gateway. I haven't used it personally, and I feel incredibly bad about that, and it's something that we can take back; that we should be able to try to receive the information in different ways, not just in structured product labeling but possibly in PDF. Make sure that it works when it's going through. So it might be we might have to do some more testing or have some more manufacturers work with us to test the system.

Use a form that is assured and doesn't need changing. Don't go changing the game in the middle of it all. Or if you're going to change it, make it an easy change for us. And also perhaps making a labeling repository part of an entire submission process in lieu of this being a separate initiative.

So those are the things that I heard, in a nutshell. I know that there were many other things. These transcripts will be available online. I'm not sure exactly when, but we'll have that, and the slides will be available probably within a few weeks. Okay. And we'll go with that.

But thank you once again for spending the day with us and hopefully we can keep the dialogue going as best. Okay.


(Whereupon, at 4:15 p.m., the meeting was adjourned.)


This is to certify that the attached proceedings in the matter of:


April 7, 2011

Silver Spring, Maryland

were held as herein appears, and that this is the original transcription thereof for the files of the Food and Drug Administration, Center for Devices and Radiological Health, Medical Devices Advisory Committee.

Official Reporter

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