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Medical Devices

Town Hall Discussion With the Director of CDRH and Other Senior Center Management, May 18, 2010 - Transcript




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May 18, 2010, 2010

8:00 a.m.

Hilton Minneapolis/St. Paul Airport

3800 American Boulevard East

Bloomington, MN 55425



CHRISTY FOREMAN, M.B.E. Office of Device Evaluation, CDRH

ALBERTO GUTIERREZ, PH.D. Office of In Vitro Diagnostics, CDRH

STEVEN SILVERMAN, J.D. Office of Compliance, CDRH


DON GERHARDT, CEO, LifeScience Alley


ERIKA NELSON, representing Sen. Amy Klobuchar

APRIL SHAW, representing Rep. Betty McCollum

ROBERT VAN TASSEL, M.D., Minnesota Heart Institute

JEFFREY McCULLOUGH, M.D., University of Minnesota

Institute for Engineering in Medicine

JOHN SHERMAN , M.D., Twin Cities Orthopedics

PETER McNERNEY, Thomas, McNerney & Partners


DAN MANS, Medical Device Manufacturers Association

DALE WAHLSTROM, CEO, BioBusiness Alliance of Minnesota

RALPH HALL, University of Minnesota Law School


SUSAN ALPERT, Ph.D., M.D., Medtronic


KIMBERLY PAPPAS, Minnesota Department of Health


MARIA BRITTLE, NexionMet Systems

SEW-WAH TAY, Libra Medical

BILL HAWORTH, President/Chief Technology Officer, PlaCor

DAVE STASSEN, Split Rock Partners

ANN QUINLAN-SMITH, President, Alquest

ELAINE DUNCAN, Paladin Medical

MARK LEAHEY, Medical Device Manufacturers Association

JOHN YEAGER, Assista Medical Systems

JOY FRESTEDT, Frestedt, Inc.

MARK GORDON, Boston Scientific




(8:15 a.m.)

DR. SHUREN: We're going to go ahead and get started. Going to ask everyone to take their seat.

Good morning. Can everyone hear me clearly enough? Yes? Good.

Well, I'm Jeff Shuren. I'm the Director of the Food and Drug Administration's Center for Devices and Radiological Health. I am very delighted to be here. But I don't know which is worse, whether it's actually being from FDA or the fact that I am a University of Michigan alum. So you will have to let me know. Go Gophers!

Today's agenda is very simple. I'm going to spend 20 minutes or so just giving an update of where we are at the Center, focus a little bit on some of our strategic priorities for 2010, and then I'm going to turn it over to you. Our first session is comprised of people who signed up to speak, and that will run till about 10:15. We'll take a break, and then we're going to have an open question-and-answer period. You can ask anything you want. If you want to raise an issue, you can raise an issue. If you have a question for one of us, you can raise a question. That's what today is about, our speaking with you to hear directly from you what's on your mind.

I'm going to apologize in advance for folks who are not used to dealing with a lot of people in Washington, but there are times you might ask a question that I can't actually answer for you. And it is not because we're trying to be coy or evasive, but there are sometimes things that are deliberative within the Agency, and it's premature for us to talk about it. So please don't take it personally.

Before I begin, I'd like to introduce some people who are here today. First there are folks from our Center for Devices and Radiological Health. I'm going to have them stand up when I call their name. Christy Foreman, our Acting Director of the Office of Device Evaluation; Dr. Alberto Gutierrez, director of Office of In Vitro Diagnostics; Steven Silverman, senior consultant with our Office of Compliance. And I'd also like to welcome several congressional members and staff here today: Congressman Erik Paulsen; Erika Nelson, outreach director for Senator Amy Klobuchar; Bethany Snyder, director of field operations for Senator Al Franken, and Katherine Blauvelt, also from Senator Franken's staff; and, lastly, April Shaw, with Congresswoman Betty McCollum.

This is the first town hall meeting for me as the Director of CDRH. And I don't have to tell you that the past several months have been a period of transition for the Center and for the Agency. I appreciate that change can create uncertainty. So right now I'd like to give you a brief sense of what CDRH is up to and where we're headed so that perhaps you can understand that this period of change at the Center will end with a greater sense of predictability and transparency for those of you who work with us and rely on us each and every day. I will keep it short so we can quickly move to your comments.

The Center's four strategic priorities for 2010, which are posted on our website along with their associated goals and actions, are to fully implement a total product life cycle approach, enhance communication and transparency, strengthen our workforce and workplace, and proactively facilitate innovation and address unmet public health needs.

I won't cover all four priorities today, but I'd like to highlight some of the key activities that may be of particular interest to you. I would also be happy to go into more detail about the topics I cover in the next few minutes, or to discuss priorities that I don't address now, during our question-and-answer session later this morning.

Laying out a strategic plan in this level of detail is new for CDRH and even for FDA. It's an effort both to set clear, aggressive timelines for ourselves in areas of activity that are critical to our public health mission and to provide our external constituencies with a window into our ongoing work and a measure of accountability. We have publicly committed to 48 goals, with a total of 123 accompanying actions, 11 of which we seek to accomplish this year. Each of them has a due date; many of them are truly stretch goals. To date we have completed 40 of these actions.

Priority 1 is to fully implement a total product life cycle approach. At any stage of a device or radiation-emitting product's life cycle, we must make well-supported regulatory decisions that take into consideration all of the relevant information available to the Center.

Such an approach depends both on the strength of CDRH's individual offices and on their ability to support each other through the seamless sharing of meaningful, high-quality information. To better enable each part of the Center to meet current and anticipated challenges and work together with a unity of effort to fulfill our shared mission, CDRH is taking several steps to enhance and integrate our pre-market, post-market, and compliance information and functions.

We're working to improve the quality, consistency, and predictability of our regulatory decision-making by strengthening our pre-market review programs.

A major component of this effort will be to complete our comprehensive, two-part assessment of the 510(k) program. As I'm sure many of you know, this past fall we commissioned the Institute of Medicine to conduct an independent review of the 510(k) program and recommend any administrative, regulatory, and/or statutory changes their study committee deems appropriate. We expect the Institute to provide us with their final report around midyear of 2011, and we'll evaluate the committee's recommendations by the end of that summer.

In addition to this external review, CDRH felt that we also needed to conduct our own due diligence about the effectiveness of the 510(k) program. We undertook this assessment in response to growing concerns over the past few years that had been raised by many of you and others in industry, by some in the healthcare community, patient advocacy groups, Congress, and our own staff about how well the program was meeting its two goals, to assure that devices cleared through the program are safe and effective and to foster medical device innovation.

Therefore, last fall I established an internal 510(k) Working Group to evaluate the 510(k) program and explore actions the Center should take to strengthen the program and to improve the consistency of decision-making, with a principal focus on the actions the Center should take in the short term under our existing authority.

The Working Group deliberations are based in part on the external input we received at a public meeting we held on February 18th and through a public docket that closed on March 19th. The Working Group is scheduled to submit its report to me by the end of this month, and we'll release the FDA report for public comment soon thereafter. We'll then determine which recommendations we will adopt prior to the Institute of Medicine completing its report.

Although it's premature for me to comment on what the Agency will propose, I can say without reservation we have no intention to scrap the 510(k) program. However, we do have an obligation -- and it's in all of our interest -- to make the program work as best as possible.

There may be some recommendations in the FDA report that we decide to move forward on quickly, changes that are so obviously necessary that it doesn't make sense to delay implementation until the Institute of Medicine study has concluded. We would begin implementation of those selected recommendations by around the end of September this year, roughly a year earlier than we otherwise would if we solely relied on the Institute of Medicine report. However, there may be other recommendations in the FDA report that we'd like the IOM to review and vet independently before we move forward with implementation, in which case we'd hold off.

In addition to assessing the 510(k) program, we're also taking steps this year to improve the quality of clinical data supported -- submitted in support of pre-market approval applications, to make sure that the safety and effectiveness of high-risk medical devices are adequately supported before they enter the market. Earlier this year we published a study on the use of clinical trials in support of cardiovascular device PMAs coauthored with experts from the Beth Israel Deaconess Medical Center. We are currently extending that review to other types of devices. A few weeks ago we posted our pivotal IDE checklist that identifies important components of a clinical trial protocol that we look at during our review of an IDE. This year we will also develop draft guidance on the design of clinical trials to be more clear about our expectations.

Beyond the pre-market arena, we're moving to make better sense and use of available information across CDRH by strengthening our systems and processes for collecting, analyzing, and sharing information to support the day-to-day needs of CDRH staff. Over the next few years we will increase our ability to capture and more effectively use meaningful data on marketed devices, in part by developing a unique device identification, or UDI, system. There has been much discussion about whether or not real world clinical data could be routinely used in lieu of more formal clinical studies in support of a PMA or 510(k). The condition precedent for such a consideration is the UDI because it's essential for linking information about the device with information about a patient's experience with the device. UDIs will also help manufacturers to conduct more efficient and effective recalls by allowing manufacturers to more quickly identify where product subject to a recall is located in the supply chain.

We're also preparing the Center to face the demands of the future, particularly with respect to globalization and in relation to new scientific developments.

CDRH recognizes that we cannot address the challenges of globalization on our own. As world markets become more and more interconnected, so too must our approaches. Therefore, over the next two to three years, CDRH will develop mechanisms to exchange and make better use of medical device information from trusted foreign authorities, such as supplementing our inspections with Quality Systems or GMP inspections conducted by other countries under the ISO 13485 audit report standard.

As part of this effort, we seek to develop a single audit program for other countries. For such a program, any inspection conducted for one country would serve in lieu of an inspection by FDA and vice versa. We've also launched a pilot effort in collaborative consultation and review of pre-market applications with Japan with an initial focus on two cardiovascular devices in an effort to leverage our respective expertise to make better informed decisions while potentially expediting pre-market review and allowing for possible simultaneous approval in both countries as a future goal.

In addition to adjusting to changes in the global marketplace, CDRH must be able to adapt as the science that guides our regulatory decision-making evolves and as new information emerges about the risks or benefits of the products we oversee. As our knowledge changes, we must be prepared to change our course accordingly. We as a Center already deal with this challenge regularly, and we typically make adjustments to our work on a case-by-case basis. But we also recognize that in order to foster innovation, minimize burdens on industry generally without compromising patient safety, and use our resources most efficiently, we need to provide industry and ourselves with reasonably predictable regulatory pathways. In fact, lack of predictability is the number one FDA-related concern we hear from industry. This is why we are reevaluating decision-making processes, particularly our pre-market review programs, to assure as much predictability as is feasible -- what others called consistency or certainty -- is one of our top priorities.

So, last fall, in tandem with the 510(k) Working Group, I established an internal task force on the use of science in regulatory decision-making. One of the first steps the Center took in terms of new information in our regulatory decision-making is how we can make it more transparent and predictable manner. The group's timeframes are similar to those of the 510(k) Working Group. The task force will submit a report to me by the end of this month, and like the 510(k) report, it will go out for public comment this summer. Both reports will tackle issues pertaining to greater predictability.

A key part of providing more clarity and predictability in our decision-making process across the total product life cycle is our ability to formalize and communicate our expectations and requirements to our external constituencies and within CDRH in a clear and timely manner. We've heard time and time again from industry that there is a need for more and also more current guidance. Therefore, we're taking steps this year to streamline guidance and regulation development at the Center. As part of this effort, we recently hired additional policy analysts as a first step toward setting up a centralized staff for strategic policy development and coordination under a new Deputy Center Director for Policy, whose selection I hope to be able to announce in the coming weeks.

Finally, a strong and fully integrated compliance program will allow us to more effectively identify and address compliance issues across the total product life cycle. Last August, Commissioner Hamburg outlined four key principles of effective enforcement, stating that FDA must be vigilant, strategic, quick, and visible in its enforcement approach.

When I joined CDRH in September, I charged our staff to develop a Compliance Strategic Plan in keeping with these principles. We announced the plan internally this past March, and we will soon make a summary available to the public on our website.

While enforcement is an important tool to foster compliance, an effective compliance program goes beyond enforcement. The CDRH Compliance Strategic Plan -- and I emphasize "compliance," not "enforcement" -- is geared toward enhancing the Center's compliance capability, largely through operational improvements. Our goals include enhancing our risk-based decision-making, better integrating our operations with FDA's Office of Regulatory Affairs, and strategically allocating our staff and resources to address critical public health needs. We are in the process of developing an implementation strategy to achieve these goals to assure that our actions are risk-based, rational, and well supported. Our staff need to be armed with more than hammers, and not everything we come across should be considered a nail. And our approach must encompass working with industry to prevent problems in the first place rather than focusing solely on the proper use of enforcement tools.

Priority 2 is to enhance communication and transparency. Effective communication begins with active listening. To improve public health and to foster trust, we'll provide meaningful and timely information about the products we regulate and the decisions we make, through strategic outreach and systems that support transparency and two-way communication.

We're developing a strategic approach to public communication, building on the foundation of the Center's Risk Communication Processes. We're also establishing mechanisms to routinely engage in a two-way dialogue with our external constituencies so that we can better understand and respond to your concerns. Today's town hall is an example of that commitment. We plan to hold two other such meetings this year: one in Boston in June and another in Los Angeles in October.

Finally, providing up-to-date information to our external constituencies about the decisions and their bases will enhance our credibility but help others to better understand the work that we do. We've been taking steps this spring to increase transparency in our decision-making, consistent with the efforts of the Agency's Transparency Task Force. Last month we launched the CDRH Transparency website, which will eventually serve as a one-stop shop for publicly released information about our decisions.

Part of being transparent is sharing information, and the new website makes available information that we hadn't previously released publicly, including data from pre-market clinical trials and summaries of our PMA 180-day supplements. But transparency is also about making it easier for the public to navigate that information by pulling it together in a usable way. To that end, the CDRH Transparency website features our new, searchable Total Life Cycle database, which integrates pre-market and post-market device information from multiple data sources into a single snapshot.

I encourage you, if you have not seen the website, to look at it and provide us with feedback. It is a work in progress. It's an iterative approach that we're taking. We're putting something out, we're going to get feedback, we'll make changes to it. So you're going to see changes to that Total Product Life Cycle tool as we continue to upgrade it. We'll also continue to put out additional information, but we need to hear back from you what's most useful and what's the best way to provide it.

Priority 4 is to proactively facilitate innovation and address unmet public health needs. Because of the many types of experts among our staff and because we see all moderate- and high-risk devices before they come to market, including nonpublic data, and gather information on them after they enter the market, we do have a breadth and depth of knowledge about device design that is not available to any single member in industry, to the venture capital community, the healthcare community, or even many of our regulatory counterparts in other countries who tend to rely on third parties to conduct pre-market reviews. This experience has usually been used to tell companies they have a problem.

However, this year, we're beginning to take a more proactive role in facilitating medical device innovation by making our experience and our experts, but not proprietary information, available to help manufacturers solve problems -- but not how to make -- more accessible -- and to develop new devices to address unmet public health needs as well as safer, more effective technologies. This is a new approach for CDRH, but one which falls squarely within our mission to protect and promote public health. Our responsibility to the public is two-fold; not only do we use our oversight to keep unsafe or ineffective medical devices from putting patients at risk, but we also foster the development of safe and effective devices. At certain times in the past, the pendulum has swung far to one side or the other. To fulfill our mandate, we must embrace both parts of our mission. That's what it means to truly take a balanced public health approach. It's about being a smarter FDA, to assure safety and use our enforcement tools wisely but also to facilitate innovation and foster a culture of quality and prevention among industry.

We recently established a Council on Medical Device Innovation comprised of representatives from FDA and other Federal agencies. We will work with our Federal Government partners on the Council to identify the most important unmet public health needs and to minimize the barriers to the development or redesign of devices to alleviate, prevent, or diagnose these illnesses.

We're also working with industry and others to facilitate improvements in the design of devices that have been associated with safety problems across multiple manufacturers. For example, in February, we announced an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. As part of this initiative, we're taking steps to foster the incorporation of additional safeguards into CT scanners and fluoroscopes. We brought a range of stakeholders together at a public meeting at the end of March to discuss potential device improvements. In the case of CT scanners and fluoroscopes, while they are generally safe technologies if used properly, changes to the design of these devices can help reduce the likelihood of user error and device malfunction that can result in excess radiation exposure.

We recently undertook a similar approach to infusion pumps. Although those actions were more regulatory because of persistent and widespread safety problems, they included efforts to make our expertise available to infusion pump manufacturers. For example, we offered to conduct a status analysis of software code to identify potential problems before a pre-market submission is sent to the Agency, even before development of the device is complete. We have developed generic software that manufacturers can use as a starting point to develop their own or to use as a benchmark to help avoid common problems we've identified from our past experience.

In addition, as innovative diagnostics and therapeutics come to us for review, we must be prepared to handle them. The promise of personalized medicine to improve patient health and reduce healthcare costs by providing the right treatment to the right patient at the right time -- and not giving the wrong treatment to the wrong patient at any time -- will not be realized if we do not have the clear and predictable regulatory pathways that foster the development of personalized medicine medical products while providing confidence in the safety and effectiveness of these products. Personalized medicine devices present unique regulatory challenges for CDRH and our sister centers, including how to apply a risk-based approach to the review of a diagnostic depending on how it is employed to guide the use of a treatment, such as selecting a therapeutic as compared to determining the dose of a therapeutic once selected. In order to anticipate and lay the groundwork for overseeing such products, we are taking steps to develop the infrastructure and processes for managing personalized medicine submissions across FDA's centers. We're working collaboratively with the Center for Drugs and the Center for Biologics to establish clear regulatory pathways for companion diagnostics. In addition, we plan to stand up a personalized medicine staff within CDRH by the end of this year.

As you can tell, 2010 continues to be quite a year for the Center. I look forward to additional progress we will make in the weeks and months to come, and I hope to continue to engage all of you and others as we move forward as a Center and enhance our ability to protect and promote public health.

Thank you.

I'm now going to turn it over, as I mentioned, to all of you. There are a number of people who signed up -- 15 in total, if you want to keep tally -- of folks who have prepared comments. After we have finished hearing their comments, we will take a break for about 15 minutes, and we'll come back for questions and answers.

What I will do is I will call up each person who's been allotted time to speak, and I'm starting with Don Gerhardt. I just ask when you come up, to please introduce yourself and where you're from.

MR. GERHARDT: Thank you, Dr. Shuren.

Two things before I get into my discussion. For all of you that are speaking, please turn your phones off so we don't have feedback on the mic as you come up to talk. And second, Dr. Shuren, I'm from Minnesota, but I also ran the medical facilities at Michigan State University. We'll take the FDA. Definitely take the FDA. I'm just kidding.

Good morning. I'm Don Gerhardt. I'm the CEO of LifeScience Alley, a Minneapolis-based, Minnesota-based trade association supporting the life sciences.

Dr. Shuren, I want to welcome you and Heather Howell and all of the CDRH FDA staff here. We really, really appreciate you being here listening to us and really, really meeting to talk about very important things, both for patients that we touch, for people that we care for, as well as the economy of this state and the surrounding area. So this pleasure and honor of you coming here to engage and talk with us, there is nowhere in the country where there is more dedication toward taking care of that patient, taking care of that person, and to innovation. We'll talk about some of the watch signs about that really fierce dedication.

So the organization that I run is the largest regional life science trade association in the United States -- and, we think, in the world. It's just now going well over 600 member organizations. From that, we get to see, I and my staff get to see incredible things happening in the innovation and the care point in this med tech device and life science industry in Minnesota.

Our organization is built different from others that you hear about, in that we have caregivers -- Mayo, University of Minnesota, and other caregivers belong to this organization that we're in -- payers and other participants that build the eco-structure that is important for a tech sector as we have here in Minnesota. It's extremely important to understand that as we talk about it today because we get to see all of the components of what happens. So that's why we're so anxious and happy to talk with you and with your people.

Through all of this, my staff and I continue to be very, very, very impressed with the people that we work with and again that drive to take care of the patient, that drive towards innovation, and it is why they get up in the morning. It's why we get up in the morning.

So now I'm going to sound a little un-Minnesotan in the next words I talk about or the words I give you. We Minnesotans are really good at what we're talking about. We are probably the best in the world at what we're talking about. So that gives us good reason to say, as you listen to the people today, they will be talking both from their hearts, from their scientific knowledge, and from their drive for innovation. And we need to keep track of that as we talk today.

Couple of pieces of information for all of you about Minnesota. This state of 5 million people ranks in the top 10 regions in the world for the number of patents in technology and business matters. That is quite incredible for a state of this size, in comparison to the rest of the world. Typically, Minnesota is rated in the top three of the healthiest states in the country, best state to live in, best K-12 education, number one to three in the places for high tech companies to start up. So there's a real legacy of health, healthcare, innovation, and application into the community. It's an extremely highly inventive place. Implantables, monitoring, imaging, cardiac, neuro, orthopedic, and urology are really focuses that go on.

Let me give you just a couple of or a few historical kinds of things to give kind of the legacy of where we're at now and where we've come from. Some of those high tech highlights are: cortisone was invented here at the Mayo Clinic; streptomycin; first direct-vision open heart surgery; transistor technology in hearing aids -- Minnesota is the largest hearing aid cluster in the world; cross-circulation in open heart surgery; blood oxygenator for open heart surgery; wearable, battery-operated pacemaker and then defibrillator; first kidney transplant; first pancreas transplant; first intestinal transplant; first FDA-approved hip replacement; bone marrow transplant -- first here; first replacement of heart valves; implantable defibrillator; first heart, lung, and liver transplants. That is legacy, and that is the reason that we want to talk, we want -- we really, really again appreciate your coming to talk with us.

So let me turn over the podium to speakers that are lot better than I, but speakers who really exemplify and represent this Minnesota quality, this Minnesota dedication and intelligence in our drive towards patient safety, care of patients, and innovation. And leading off that will be one of our extremely important legislators, Representative Erik Paulsen.

REP. PAULSEN: Well, good morning. And I also just want to thank everyone for taking the time to come this morning to a very, very important event, critically important topic not only to my congressional district and to Minnesota but also the entire country.

And I want to start just by recognizing and thanking Dr. Shuren and his team for picking Minnesota and gathering input directly from this community here. You certainly picked the right place to start. Our nation's best and our brightest leaders, I think, are right here -- in this field are right here in Minnesota.

And as some of you know who are here today, I serve as a co-chair of the House Medical Technology Caucus. When I first took office last year, I made becoming an active member of this caucus a top priority because I know how important medical technology is to Minnesota. With over 400 medical device companies in Minnesota employing tens of thousands of people in our state alone, the impact of this industry certainly cannot be overstated. The medical device industry is both a Minnesota and an American success story, and I want to work to help keep it that way. The innovation that it fosters means longer lives, healthier patients, good-paying jobs, and economic growth. In fact, the device sector is so successful that it's one of the few that actually enjoys a positive trade balance today.

The FDA plays a very crucial role in the medical device industry, primarily in helping ensure that products are safe and effective when they come to market. Now, at the same time, a delicate balance must be struck so we aren't blocking or slowing patients' access to important lifesaving innovations. Of course, it is absolutely critical that medical devices are safe for consumers and for patients. If a device is not safe, it should never go to market.

And I will tell you that in my many visits to the medical community throughout my district, I have heard from numerous people representing every facet of this industry, and they certainly share a steadfast community -- commitment to safety. But again and again I hear -- personally -- serious concerns about how the current regulatory trend has been to make the approval process more and more onerous, making it extremely difficult to bring a product to market. Another problem I often hear about is the uncertainty that companies face in working with the FDA. Manufacturers are seeing changing requirements and a slower response time as they move through the process, and this uncertainty influences the level of investment in medical technology. If an investor has less certainty that a product could actually come to market, there is little incentive to actually invest in that technology, no matter how good the product might seem. And these factors are also eating up research and development dollars, money that could instead be spent on these new lifesaving technologies and devices. And on a macro level, I will tell you that I have heard worries that companies could move their operations or their expansions overseas where the approval process is more certain and also less drawn out. I think we just need to work to keep the innovation here, to keep the jobs here, to keep the patient care here, and to keep the technology here.

And I understand the risks of bringing an improved product to market are high for the FDA -- there's little recognition for doing something right, and there's plenty of attention if something goes wrong -- and I applaud efforts to reduce the number of recalls and to make sure that products are safe. But these efforts must also be relevant to the device. As one manufacturer that I spoke with recently said, "More rigor in the approval process is okay as long as it's relevant."

And so, in short, we just need smart, effective approval processes that will protect patients while also continuing to foster that innovation and economic growth that this industry has long, long provided. And today's event is a perfect place to start that dialogue and improve that process. Again, I want to applaud you for taking the time to come to Minnesota, and I look forward to hearing the comments and thoughts of others in this room as we work in dialogue towards that end.

Thank you very much.

DR. SHUREN: Erika Nelson.

MS. NELSON: Good morning. My name is Erika Nelson. I work for Senator Klobuchar here in Minnesota.

The Senator really wishes she could have been here this morning. This is a very important topic to her. But she wrote a letter that she had asked me to read. And I'll be here throughout the morning and that break if anybody wants to come up and talk and exchange business cards or something like that.

"Dear Friends,

"First, I want to thank the Food and Drug Administration for holding this town hall meeting and for their willingness to hear from the medical device community in Minnesota.

"This forum provides the opportunity to work cooperatively with industry to promote technological innovation while also ensuring the safety and effectiveness of medical devices. This is essential for American patients to continue to have access to the best, most advanced medical technology possible.

"I have talked, however, to a number of my constituents in the medical device community regarding policy changes under consideration by the FDA. Many are concerned that these changes will add new and unnecessary regulations resulting in an even longer and more complicated approval process for medical devices. In the current economy, it is already hard enough for companies, especially smaller companies, to get the capital they need.

" Minnesota has a lot at stake. Our state has led medical innovation for more than 60 years and boasts more than 400 medical device companies that together employ more than 30,000 people. Continued innovation and development in the medical device industry is not only important to Minnesota but to the rest of the world. The U.S. is the world's only net exporter of medical devices, with a $5.4 billion annual trade surplus. As chair of the U.S. Senate Subcommittee on Competitiveness, Innovation, and Export Promotion, I intend to hold a hearing to look at the importance of medical devices and export promotion.

"The FDA and our medical device industry have enjoyed decades of success in working together to ensure that medical devices receive the appropriate level of scrutiny. I urge the FDA to maintain this tradition of successful cooperation so patients can continue to benefit from the most innovative medical technology in the world.


"Amy Klobuchar"

Thank you.

DR. SHUREN: April Shaw.

MS. SHAW: Hi. I'm April Shaw from Congresswoman Betty McCollum's Saint Paul office. And, like Erika, I also have a letter to read from my boss.

"Dear Friends,

"It is fitting that Dr. Jeffrey Shuren is here in Minnesota to hold the first in a series of FDA town hall meetings. Minnesota is a global leader in the medical device industry, and ensuring a swift, effective, and conclusive FDA approval process is essential to our state's innovators and device developers.

"FDA has a vital role to play regulating and approving medical devices, but it must also be a partner with device developers to provide a transparent process that moves innovative, safe, and effective devices to the marketplace to meet the needs of patients.

"Welcome to Minnesota, Dr. Shuren, and I look forward to working with you to keep Minnesota's device innovators successfully contributing to important medical advances.


"Betty McCollum,

"Member of Congress"

DR. SHUREN: Dr. Robert Van Tassel.

DR. VAN TASSEL: Good morning.

Dr. Shuren and the staff of the FDA, we welcome you to Minnesota, and I commend you for reaching out to the community, particularly Minneapolis, and addressing these issues that are critical to you and obviously critical to us.

My name is Robert Van Tassel. I'm a recently retired cardiologist. I served 39 years as senior consultant in cardiology at the University of Minnesota and at Abbott Northwestern Hospital. In addition, I have worked in the medical device field. I have seven issued patents and worked with numerous medical device companies. So I have somewhat of a unique background, both on the inventing side, the entrepreneurial side, as well as the clinical side.

What I'd like to address today though is primarily the patient because of all of us constituents in the room today -- we have engineers, inventors, small businesses, large businesses, government -- but really the most important constituent is our patient. That's the person that benefits directly from what you do, what I do.

And I can tell you, as a physician, nothing is as powerful as when that patient comes back 6 or 8 weeks after having a new defibrillator or pacemaker or heart valve and the look on their face and the look on the patient's family's face of almost a new person. Particularly, if I look back 39 years ago when I started practice, all we had at that time was a pacemaker with a single lead and a single chamber that lasted 18 months, in which time the patient had to come back for a new generator.

Let's fast forward now today, and if we put in a pacemaker, frequently that patient won't have to be seen for 7 to 12 years for a pacemaker change, they're followed trans-telephonically over the telephone, and we can pretty much interrogate not only what the pacemaker is doing but what the patient is doing. We can look at the human dynamics of that patient. We can take somebody that's in heart failure, take them out of heart failure by cardiac rhythm management or resynchronization pacing. Take a patient that was laying in bed during the day and at night couldn't go to bed because they'd be short of breath and would have to sit up in a chair; a pacemaker, a sophisticated pacemaker like that put in, the patient will come back in 6 to 8 weeks feeling 100 percent improved. That critical importance to us as a physician. There's nothing that rewards us more than the look on the face of those patients when they come back.

All of that is due to innovation. Innovation from the single-chamber pacemaker to the smart pacemaker to the long-lived pacemaker to the pacemaker that not only treats heart rate but it treats heart contractility.

I could go through a whole series of things. The defibrillator patient. The initial defibrillator was just a dumb defibrillator that sat in and worked only when that patient went into ventricular fibrillation. And today that same defibrillator is put in, it's very small, fits under the skin -- even in a small woman can have that done. It monitors the patient, tells me about the patient. Patient goes off all the medications that they were on before that made them nauseated for 7 or 8 years while they were taking it. Now they come in and they're essentially cured of that problem.

That's innovation, and without innovations, the people that suffer the most are not the engineers, are not the small companies, not the doctors, but the patients. And that's what I want to represent here today is that very, very important constituency of our patients.

I'll just go through just a few others in this area because I think it's so important that we all keep that very aspect in mind, that is, the patient as the key stakeholder here. And in some ways it would have been nice to have two or three patients that might have volunteered to come in, such as Medtronic does at their yearly meeting when they bring in a patient with a heart valve or we'll bring in a patient that might have had stem cells and so forth.

I'd like to mention heart valves. Again, if we go back 39 years when I first started in medicine, we had two heart valves, both of which didn't work very well, both of which were very noisy. Some of you may remember that when the heart would pump, we'd hear that click. Even the patient's wife would hear that in bed. You had to be on high-dose anticoagulants for it, and that valve would last 7 to 12 years, the tissue valve sometimes 3 to 5 years. So the patients were almost always geared for another operation. Today, fast forward to where we are today, we have over 12 heart valves, they require minimal anticoagulation, they're totally silent, and the vast majority of them don't fail ever. The easiest patient for me to take care of is today's heart valve patient. They're happy, they do well, they require mild anticoagulant, and their valves just don't fail. All innovation. And the biggest beneficiary of that innovation again is not us in this room; it's the patient that is beneficial of all of that advancement.

Let me record just one other aspect. If any of us today could go back again to the mid-1960s and have a myocardial infarction -- a heart attack -- we would be in the hospital. The ambulance would take us down to Hennepin County Hospital. They'd put us in a coronary care unit where we'd stay 7 to 10 days. We'd then leave this coronary care unit, we'd be in the hospital for 3 to 4 weeks, we'd go home, and they'd keep us out of work for 3 to 4 months. We'd then return to work with a weakened heart. Today, if any of us, God forbid, should have a heart attack today, they'd take us down to perhaps the same hospital but variety of hospitals in Minneapolis. You wouldn't go to a coronary care unit at all; you'd go to the cath lab. The doctor would open that artery, place a stent in it. You'd go home in 48 hours, not in 3 to 4 weeks; you'd go home with a near normal heart, not a weakened heart; and you'd be back at work in 2 weeks. Beneficiary: not only the patient, but society and total cost. That's innovation. The innovation there was angioplasty, balloon catheters, guiding catheters, intracoronary stents -- all innovations. Many of those innovations, as was pointed out, came from the state of Minnesota, our companies here, in Medtronic, in USCI -- or CPI and variety of other companies. St. Jude had major, major role in developing these products.

I know we have an orthopedic surgeon talking, but I couldn't help but pass up just a little bit of note on orthopedic because it's so dramatic in my practice that when our heart patients come back, sometimes their major problem is not their heart anymore. Fortunately, there's been much innovation here, and the advancement has been great. But it took a while for that same technology to reach into degenerative arthritis. And the patient would come in walking with a cane, perhaps in a wheelchair, frequently couldn't golf, couldn't do the things they wanted to do, and frequently could not be employed. If you fast forward, today -- and I'm sure this will be commented on -- the orthopedic surgeon now puts in an artificial hip, a total hip, and that patient now gets rid of his cane, he's out of his wheelchair, frequently back to work. Major, major advancement. If you talk a quality of life, that's a major change in quality of life. And all of that is innovation, and the real major beneficiary of that innovation has been our patients.

I could do the same thing with drugs. And I'm talking to the choir here, I know. But we could, if we look at drugs. For instance, the statin drugs. Half of people here are probably are on statins. But in my total career of 39 years, in the 39 years of practicing medicine, no other drug has done what one drug has done, the statins. It's reduced myocardial infarction, chest pain, and sudden death by 34 percent. Major, major improvement. One pill, one drug. And that took a long time, many hundreds of millions of dollars to come through the regulatory process. But who benefit from it? The patients benefit from it. Major change in lifestyle, major change of longevity.

One of the things I think that is more important -- we talk about increased longevity and we talk about, if you look back a hundred years, we're living 30 years longer. Major change in longevity. But as a physician, as the patient -- sees those patients, I think one of the more important things than longevity is quality of life. And many, many of these innovations, as I've tried to point out this morning, changed the quality of life dramatically.

And I guess my imploring to the FDA, to industry, the engineers, the entrepreneurs is let's not for one second slow down innovation. Innovation is so dramatic, it's so necessary, and its track record is so strong -- and I've seen the results of that -- that it would be a shame if anything were to slow down that process. You know, some people say that "Well, that's what it was in 1965, you old guy, and today I think all the advances have come." But if you'd look at it, the University of Minnesota, Mayo Clinic, or Minneapolis Heart Institute today, what we're dealing with today are those next-level generation of products -- stem cell research, the Cool It programs for cooling the heart -- things that we haven't or aren't on the market but are just getting ready and coming out, and there is a huge, huge number of these.

So my concern today is primarily for the patient. I hope to have pointed out the benefits of what we do collectively in this room and what you do collectively as a government to help us do this. And by all means, let's facilitate it, as you said in your opening statement, not hinder it.

Thank you again for coming today. Thank you for the opportunity to speak with you today. We appreciate it. And I commend you for working with us together in this problem.

Thank you.

DR. SHUREN: Dr. Jeffrey McCullough.

DR. McCULLOUGH: Thank you, Dr. Shuren. Welcome to Minnesota, and welcome to the rest of the FDA staff that's here.

I'm Jeff McCullough. I'm a professor of laboratory medicine and pathology at the University of Minnesota. I'm here this morning because I'm also the Director of the Institute for Engineering in Medicine at the U. This institute has about 120 faculty members from the medical school, engineering sciences, pharmacy, dentistry, veterinary medicine, nursing, and so on. Our major focus is the support of research and development for engineering solutions to medical problems to improve patients' health. Our members are in 36 different departments in the medical school, and our major emphasis is -- not only the medical school. I'm sorry. And the other colleges as well. Our major emphasis is the support of research.

Over the last several years through our institute we've spent about $5 million on fostering research on the part of university faculty. This, we think, has been pretty successful. It's resulted in about 200 publications. And what we're particularly proud of, it's generated about $5½ for every $1 we've spent on research -- $5½ in new, external funding. But particularly for this morning's discussion, this has also led to 15 patents.

As we look at the development of a new medical device through the university process, there are probably 15 or 20 different steps. I'm not going to bore you with listing all of those. But, for instance, these -- one of the things that we do a little differently is -- I'm sure everybody here is familiar with the old adage of "bench to bedside." We focus on beginning with problems, beginning with patient problems or patient needs, and so we adjusted that phrase a little bit to be "bedside to bench to bedside." In other words, we identify patient needs and patient problems, we then put together the right kind of collaboration from the health sciences and engineering in order to address this issue, hopefully ending up back at the patient's bedside with something that we can do to improve health.

In this process, we think there are probably 15 or 20 different steps in developing a new medical device within the university faculty activities. And as I say, I won't bore you with all of these, but they range from the original patient concept to an initial design or a computer-assisted design, biomaterials, in vitro laboratory studies, development of a prototype, small animal studies, toxicity studies, large animal studies -- all of the things that need to be put in place in order to arrive at first-in-human use.

And this is the area that I want to focus on for this morning's discussion. We, like everyone else, don't have a huge amount of money to invest in these kinds of activities, so it's absolutely essential that we understand as we start down that pathway what the regulatory expectations are going to be and what kind of data that we need to develop at each of those steps so that we can do this in an efficient and in a timely and in a cost-efficient manner. You know, we're a university, so you might think that we're little fuzzy-headed academics, but in fact we really have to have tight control on the management of these processes so that we can efficiently use our limited funds to move these developments into the pipeline.

And let me just give you examples of the kinds of things that can sort of inhibit this development if we aren't clear as we go along exactly what the data needs are and what the regulatory expectations are. For instance, talented graduate students tend to graduate and they leave. And while we have a large number of graduate students, many of these devices that are under development are so unique that we really do depend on one or two graduate students and one or two key faculty to provide the talent and the expertise that's needed to move a project forward. A faculty member may get a new grant which somewhat diverts their attention from the original focus of the device that they were working on. Or various things like this occur. And, in addition, if we -- if the regulatory expectations change during the process, this can divert the faculty's attention, it's going to cost us more money, and it may actually delay or even kill the process of developing this device within the academic environment. So, because of the success of patents that I just mentioned, I think we do have a history of successfully developing devices and leading to commercialization within this academic environment, but it's essential that we understand as we go along what the expectations are so that we can generate the right kind of data at each step in order to keep the process moving.

So I think -- oh, I know. The other thing I wanted to say is we do understand that new science may occur during the process of developing a new medical device. This may occur because of data that we generate in the process of doing this, or it may be external data that is pertinent to this particular device. That's to be expected, and we are an academic faculty, and we respond to new data and new science. So, Dr. Shuren, I want to make the distinction here of we understand that there will be new data, there will be new experience, there will be new science that occurs as we go through this process. And that's great. We respond to that and value that. What we want to try to assure is that, apart from that, that we understand what the clear regulatory pathway is in the process of developing these new devices.

So thank you for the opportunity to comment just a bit, and, again, thank you for coming.

DR. SHUREN: Dr. John Sherman.

DR. SHERMAN: Thank you, Dr. Shuren.

I'm John Sherman. I'm an orthopedic spine surgeon practicing with Twin Cities Orthopedics. I've been a spine surgeon for 20 years.

And one of the reasons why I chose to go to UCLA and uproot my family to do a fellowship was because spine and orthopedics was an area where I saw a lot more opportunity for innovation, an ability to treat patients, as Bob Van Tassel said, in a better way. And it is very satisfying to have the patients come back, and the person who couldn't walk out onto the baseball field because he had such severe spinal stenosis could walk out now from the new bullpen at the new Twins stadium all the way to the pitching mound and can do so because of the technology that wasn't available 20 years ago but is available now.

That being said, it's very important -- and this, again, for the congressional staffers, I think this is important to understand. It's a collaborative effort. It's a collaborative effort between industry as well as the surgeons. And the collaborative effort between those practitioners and industry is a positive thing, not something that should be unfortunately lambasted at times in the press. I can't do what I do -- even if I have a brilliant idea, I'm not an engineer, I don't know biomaterials. I need to tap into industry to allow me to do that. And yet, if it's felt that this is tainting me or tainting that aspect, that innovation gets stopped.

The other aspect I think that's very important -- and, Dr. Shuren, you mentioned many times this aspect of innovation. But it's also, does it get stifled, and has the FDA recently been creating problems -- again, because of lack of predictability -- in stifling that innovation?

I've had the opportunity over the last 8, 9 years where I was the medical director of a company called Disc Dynamics. And again I mentioned "was the medical director" because unfortunately that company was shut down the first of the year, and it was shut down primarily because of some of the lack of predictability surrounding the FDA.

This was tremendously innovative technology. I would argue that it was probably some of the most innovative technology that I have ever seen as a spine surgeon. It allowed me to treat patients that I can't treat now and do so in a much less invasive way.

The product was approved in Europe, had a CE mark. We did a study in Europe of almost 100 patients with very, very good results. The FDA required us to do some studies, a very rigorous study looking on rats that delayed our implementation of a study here in the United States by about 2 years. That study was done. We then started a study here in the U.S., a pilot study to 20 patients. The FDA then asked us to do another set of 20 patients, and in the discussions with the FDA, we would follow these patients for 3 months and then apply for our definitive IDE study. What's important to understand is that, again, the study that we were doing was the identical protocol that we used over in Europe with a large compendium of data that was submitted to the FDA. The FDA said, "Okay. Follow them for 3 months, apply for the IDE, and then we can start the study." That was done.

Concomitant with this was, of course, this was a venture-funded company and we needed money. I mean this takes a lot of money to do a study like this. Unfortunately, the FDA came back and said, "Sorry. We need you to follow those patients now for 24 months before you can even apply for your IDE study." That's a game over. I can't go out and raise money, the venture capital people won't fund that, and right now I have patients that I can't treat because of the lack of predictability and therefore the added expense of trying to get this to market.

And I was recently at a meeting where one of our investigators came up to me and said, "John, why did this thing shut down?" And there was a venture capital person standing right next to me. I said, "Talk to them." But then again, I thought, "You know, if I was a venture capitalist, which I'm not, I wouldn't have funded that company because I don't know when will this thing ever reach the endgame, given the lack of predictability where the FDA is right now."

So, Dr. Shuren, you mentioned in your opening remarks the need to foster innovation and the need to be predictable, and I think that's very, very important. Because that 23-year-old girl that I had in my office last week, which I hope I can take to Europe, if we can actually get this resurrected over in Europe, is the ideal patient for this device. The current devices that I have, it's a lot bigger operation. If that was my daughter, I wouldn't recommend any of the operations that I have available to myself to treat her. Unfortunately, right now, because of the lack of predictability, it's not available here in the U.S. or even outside the U.S.

Thank you.

DR. SHUREN: Peter McNerney.

MR. McNERNEY: I was wondering how I was going to get from patients and science to venture capital, but, John, thank you.

I'm Pete McNerney, a partner at Thomas, McNerney & Partners, a venture firm focusing on medical technology and life sciences based in the Twin Cities.

I want to start by saying that my remarks are consistent with and endorsed by both those of the Minnesota and National Venture Capital Associations.

As venture capitalists, we invest in innovative technology employing capital provided by large institutional investors including many public pension funds. To be successful, we work closely with early stage companies to help them navigate the many challenges of developing a product, building a business, and ultimately gaining the acceptance of a sophisticated and discriminating market under increasing pressure to reduce costs.

We exist because there are no other sources of capital for companies with no sales, no profits, and few fixed assets. The primary assets they have are passionate people and intellectual property. Without venture capital, they simply wouldn't exist. The entire biotechnology industry and most of the breakthroughs in medical devices were funded at their early stages by venture capital.

The need for venture capital is not going away. Large companies do not have the right incentives to obsolete their own technology, and the public equity and debt markets will not provide capital to companies years away from sales. The typical venture capital investment in a startup med tech company before a product is approved is somewhere between $30 and $100 million.

In addition, the industry creates valuable jobs. More than 80 percent of the 8,500 medical device companies in the United States have fewer than 50 employees. Many have little or no sales. And yet these are the primary sources of innovative new products. Eighty-three percent of all employment in the medical technology industry is in venture-backed companies. Why are we so sensitive to these issues here in Minnesota? You've got some flavor of that. But the state employs over 30,000 people in the medical device industry, which is the highest per capita employment for this industry of any state in the country. They are well paying, professional jobs, and each of these jobs creates another 5½ jobs throughout the country, a majority of which are in Minnesota. From a venture capital perspective, 60 percent of all dollars invested in Minnesota are invested in med tech, compared to 13 percent nationally.

I am here because the venture community both nationally and in Minnesota is moving away from investing in medical technology. Venture capital investment in medical devices in the United States has declined by greater than one-third over the last 2 years, a decline that is more dramatic for companies that are raising their first round of capital. In Minnesota, the average amount per year invested in venture-backed medical device companies for the 5-year period ending 2008 was $380 million. In 2009 it was 174 million, and in 2010 it is on pace to be less than that. There are a number of reasons for this decline, but an important one is that the regulatory process has become long and uncertain and in many instances unnecessarily burdensome. As a result, we have lost our ability to evaluate regulatory risk.

Why have we reached this conclusion? The review process is inconsistent, unpredictable, and too often subject to change; communication with CDRH is difficult, inefficient, and lacks clarity; CDRH seems too focused on the avoidance of risk rather than the promotion of innovation; there is a lack of experience and expertise on review teams and PMA panels; the FDA seems to us to be overly fearful of conflict of interest, depriving industry of a voice in the debate; and too often there are personnel changes during the review process leading to delays and duplication of work. For these reasons, some companies have failed and many have fled to Europe. The U.S. has been a world leader when it comes to developing novel medical technology. Maintaining this competitive advantage requires a clear and consistent regulatory review and approval process.

So what do we propose? For truly novel technologies, we support the National Venture Capital's proposal of a special, well-defined regulatory pathway that is flexible but predictable and that includes a clear definition of novel technologies; in addition, dedicated resources within the FDA for novel technologies and a well-defined but flexible review process. The approval requirements should be based on risk as determined by the intended use of the device and should be reviewed by a senior team of a highly qualified regulatory reviewer working together with advisers and panel members well versed in current science and medical practice and with intimate knowledge of the technology and the intended clinical use.

For extensions of existing technologies, the 510(k) program was established to eliminate the need to re-prove what predicate devices had already established. The 510(k) program has been successful, and thousands of new devices cleared through the program are now helping people and saving lives. We strongly encourage you to work in concert with industry and with knowledgeable clinicians to improve the program and in the process reward good science and establish a level playing field. In doing so, we propose that you maintain and strengthen the substantial equivalence program, utilize more effectively the de novo program, reemploy the concept of least burdensome proof requirements, and improve but work within the class I, II, and III designations, although we do recognize the need to modify and improve the class II category.

In closing, investors accept the risk and challenges of demonstrating safety and efficacy and the considerable difficulties in gaining market acceptance for new products and technologies; however, we do not have the financial resources to take on the risk of an unpredictable and unevenly applied regulatory process.

Thank you for coming, and thank you for listening.

DR. SHUREN: Martin Emerson.

MR. EMERSON: Good morning.

Echoing all the other thanks, genuinely appreciate you making the efforts to come see us this morning.

My name is Marty Emerson. I am the CEO of Galil Medical, a small medical device company focused on interventional oncology. I sit on the board of three other medical device companies, and I have previously served on the board of AdvaMed.

I'm here to discuss the medical device industry's perspective in three issues: first, why it is important that any changes that are implemented are truly the right changes; second, the medical device industry's concerns with the current PMA process; and, third, our views on how best to refine the current product approval processes.

Let me start with why getting these changes right is so important. Nearly every day, a clinician, an engineer, or a researcher is coming up with ideas for new and innovative products. These innovators then need to convince someone who has access to resources as to the merits of their ideas. This is true for a physician who has a breakthrough moment, an engineer at a company who has been working on a concept, or an entrepreneur who believes that he or she should be building a new company based on their idea. This is how innovative products are conceived of, thereby benefiting thousands and thousands of patients every year.

An unintended consequence of the current regulatory environment is that too many companies are focused on developing incremental products that utilize the 510(k) process versus developing truly novel products that would follow the PMA path. There are also too many examples of U.S. companies whose products have proven safety and efficacy in Europe and yet they cannot get traction in the United States towards approval.

Reform that is not thoughtfully implemented will continue to dry up the investment dollars that are required for new innovation, investment dollars that CEOs are finding harder and harder to find every day.

The medical device industry recognizes the need for reform. Here are the most critical shortfalls as we see them: first, at times it appears there's more focus on risk and the avoidance of risk as opposed to the balance between risk and potential benefit; second, the PMA process can sometimes suffer from a lack of specific expertise that is required from the review teams, further exacerbated by CDRH personnel changes; and, third, recognizing that PMA panels are dealing with very complex clinical issues, the physicians who are oftentimes the best equipped to sit on these panels are now being excluded because of concerns regarding conflicts of interest. Too often, in our view, the panel is then filled with physicians who are not necessarily clinically experienced enough to understand the entirety of the specific and particular issue or situation at hand.

The long-term impact of companies shying away from the truly innovative products that require PMA pathways is significant from both a patient care and a macroeconomic perspective. Existing U.S. medical device companies simply won't need to employ as many people as they have today and new companies simply won't be created.

The dollars that are required to bring new products to market are recognized as extensive. R&D, clinical research, regulatory, and reimbursement resources are all required to develop and bring new concepts to market. Often, animal work is required to prove a concept. And then extensive in vivo work is involved to make sure the final determination as to the safety and efficacy of this new product. These steps are by their very nature expensive, time-consuming, and the risk of outright failure is very high.

Importantly, maybe ideas won't make it to the market because companies have already assessed that the products do not work or are not safe. Also, companies withdraw products from a market -- even approved products will be withdrawn from the market -- because they prove to either be unsafe or not working. There is no incentive within a company to market a product that is not safe or effective. The negative impact to a company with respect to its reputation, the financial impact if a product fails are simply too high. We believe that these natural constraints need to be considered when evaluating changes to the regulatory processes.

The medical device industry has some thoughts on how best to reform the current PMA process. First, for technologies that are highly innovative and novel, we'd like to see well-defined regulatory pathway, formal yet flexible, open and, again and again and again you'll hear today, predictable. Second, we'd like to see dedicated resources within the FDA for the really complicated technologies that we know you're wrestling with on a regular basis. And, third, we'd like to see reviewers work with clinicians who are fully versed in the specifics of the indication and the technologies that we're talking about. Perceived conflicts of interest we believe can be more readily handled via more thorough disclosures.

The medical device industry is of the view that the 510(k) program has largely been successful with thousands of products that have been cleared under this program and that are today positively impacting the lives of millions of patients around the world. We advocate that the class I, II, and III designations remain in place. We recognize that there are ways for the 510(k) program to be improved within the existing statutory framework, and we propose the following three changes: first, refine and reemploy the concept of least burdensome proof requirements; second, the substantial equivalence program should be maintained but requires clarification; and, finally, we believe the de novo program can be used more effectively.

In closing, we believe, I believe the future of healthcare remains very bright, and we are confident that the many wonderfully innovative ideas that are sitting on drawing boards with engineers and clinicians and entrepreneurs can still be brought to market. But those ideas unfortunately run the risk of remaining on the drawing boards if the changes we're talking about today aren't carefully implemented.

Thank you.

DR. SHUREN: Dan Mans.

MR. MANS: Good morning.

Dr. Shuren, other esteemed members of CDRH, thank you for the opportunity to provide comments on your 2010 priorities. Your outreach demonstrates a willingness to partner with industry as we pursue safe and effective innovation.

My name is Dan Mans, and I am speaking on behalf of several senior clinical, regulatory, research and development professionals from across our industry who are concerned about trends we see developing at the FDA.

Ours is an expert group. We have managed many successful original PMA applications, have testified successfully before FDA expert panels, and secured countless IDEs and 510(k)'s. We come from big companies and small, serving essentially every sector of this industry.

As a result, our group can appreciate the difficult challenge you face as an agency. You have a conflicted charter: protect the public health by assuring safety and effectiveness of devices and speed innovations to market. Pursuing either of these with absolute resolve will compromise the other. This is the same challenge that we face as an industry. Is the device good enough? If we take additional time to make it better, will more harm come to the public health while those who suffer waiting for this device await it?

We respectfully challenge the FDA to look carefully at how its current initiatives are impacting innovation. There has been much said about devices that reach the market with inadequate regulatory scrutiny. Pressure from Senator Grassley, Representative Waxman, the national press, and vocal citizens have suggested that the FDA is not doing its job and should further restrict devices from the market. But in all this, we have seen no data indicating that the Agency is releasing unsafe devices.

However, when we look at innovation metrics, we do see a problem. According to FDA's own public reporting, CDRH has approved no more than four original PMA application in each of the last four fiscal quarters. No other 12-month period in the last decade has had fewer approvals. In fact, there have been only two other quarters within that timeframe in which four or less original PMA applications were approved, and we've now had four in a row. FDA's efforts to speed innovations have been compromised.

Our team has developed recommendations that are intended to help CDRH speed innovations to market without compromising its attention to safety and effectiveness. Due to the time restrictions at the podium today, I will summarize these recommendations in three areas and leave you with a document that we prepared that provides additional comment for your consideration.

First, regarding the 510(k) program, we generally agree with the formal comments already submitted by AdvaMed and the Medical Device Manufacturers Association but believe that the following deserve emphasis.

The general framework for the current 510 program is sound and should be retained. It recognizes that device innovations are often found as the result of iterative change rather than large advancements and that devices are distinct from pharmaceuticals in that the effects are localized rather than systemic. The program has efficiencies that allow industry and the FDA to leverage what is known from already marketed devices and gives the Agency authority to request sufficient additional data to resolve new questions brought by the new device.

The Agency has expressed concern about the use of multiple predicates and predicate creep. We consider the fact that predicates build on each other to be an inevitable and positive result of innovation and are not aware of any data suggesting the use of creeping predicates has led to the clearance of unsafe or ineffective devices.

Listing multiple or split predicates admittedly adds complexity to the substantial equivalence determination, and applications using this technique need to be constructed with careful and critical consideration. But it would be wrong for the FDA to eliminate this method for establishing substantial equivalence. Multiple predicates allow industry and the FDA to draw upon what is known from multiple technologies that have relevance to the substantial equivalence determination and may have many years of safe and effective use in the marketplace.

Most importantly, unless the FDA has performed a systematic review of clearances and found the use of multiple, split, or creeping predicates to be the source of decision-making error, we assert that the basis for concern is theoretical and not founded.

Industry recognizes that some class II devices require considerably more data than others, and we agree that there should be high standards for the evaluation of medical devices. Additional written guidance, clear requirements definitions, and more reliance on internationally accepted standards would be helpful improvements to the 510(k) program, thus minimizing sponsor/review team negotiation, late-changing requirements, and reviewer discretion that's commonplace today.

In addition, we consider the de novo process to be an excellent and appropriate construct for retaining regulatory oversight of novel devices that do not require full PMA review. We would like to see the de novo process altered to ease early interaction and speed the development of special controls for these new devices. Today, the pre-IDE is typically used to address these issues, and we find this inefficient.

Second, regarding level of evidence, we find it common for review teams to seek information from sponsors out of scientific curiosity rather than as required by the regulatory standard. We ask FDA management to address this issue through training and education in the statutory requirements, perhaps installing a process or a checklist for review teams to justify new or changing requirements on the basis of the regulation. We suggest least burdensome principles be reinstituted as the standard by which requests are made and recommend that each review team have a least burdensome champion to assure this.

Lastly, regarding management oversight and dispute resolution, it is unreasonable to expect review teams will make the right decisions 100 percent of the time. Management oversight is essential to the proper application of statutory requirements, and there will be occasions when management needs to overturn decisions. In a healthy and functioning organization, this is expected and embraced and does not form the basis of whistleblower actions.

The Agency has established a standard operating procedure for resolving internal differences of opinion. The document describes what I believe is an administratively cumbersome procedure in which individual opinions within the Center cannot be overturned without the concurrence of two levels of management. Even then, the individual has continued access to appeal in what could be a very large drain on already sparse Agency resources.

We recommend revisions to this SOP that establish clear management authority without apology and adds an element of public transparency that will ensure that neither management nor the working level contributors garner more authority than warranted for good decision-making.

Thank you for giving these ideas consideration. Industry stands ready to work with the Agency on these important topics and looks forward to further dialogue as you pursue changes to the regulatory process.

Dr. Shuren, here is a copy of our prepared document.

DR. SHUREN: Well, I guess I won't be reading the new Nora Roberts book on the flight home so --

Dale Wahlstrom.

MR. WAHLSTROM: Good morning. And I'd like to add my welcome to you, Dr. Shuren, and to your staff from FDA.

My name is Dale Wahlstrom, and I have 30-plus years' experience in industry ranging from computer industry and appliances and most recently medical devices. And but I am here today speaking to you as CEO of a 501(c)(3) nonprofit called the BioBusiness Alliance of Minnesota, and it's with that hat on that I'm addressing you.

The mission of BBAM, as we call it, is to grow the life science industry in the state of Minnesota and ensure that our region is prepared to compete in the bioscience world of tomorrow as well as the reality of today. We define the industry with six different markets. Those markets are medical devices, pharmaceuticals and biologics, animal health, food, renewable energy, and renewable materials.

Our organization was kicked off in 2004 in a partnership or a dialogue between Don Gerhardt of LifeScience Alley and the Governor of the state. We are partially funded by the State of Minnesota, but much of our -- but mostly from foundations and other granting organizations that share the same kind of mission that we have.

We understand that for a community to be functional and growing and healthy, it takes a strong working relationship and partnership between the public, academic, and private sectors as they work together. For this reason, our board of directors is made up of operational leaders from the state and local governments, academia, and the private sector. We are all partnering together in an effort to optimize our investment in new knowledge creation and workforce development by our academic sector, by the -- and in our private sector for commercialization of new products and new ideas, and in our government sector with the policy, oversight, and investment categories. It's a tough balance to strike, but it's one that is necessary to create an ecosystem that works for our citizens to create jobs, wealth, and opportunity for they and their families. When a system is out of balance, it suboptimizes and everyone loses.

The State of Minnesota is nearly 30 percent more dependent on the economy than the average state in the United States. Within the category of life science industries, the medical device industry is a dominant industry for us here in the state, second only to food in total employment. In a study that we completed in 2006, we identified that there are about 32,000 people that are employed directly in the state in the medical device industry, and there's somewhere just south of 200,000 whose jobs are connected indirectly through service or other types of support organizations. As you can see, it's an important, a very important industry to our state and our economy.

Unfortunately, from our perspective, it appears as though the device ecosystem is becoming out of balance or may already be out of balance, not only in the state of Minnesota but in our country. As a result, one of the remaining industries where the domain knowledge is dominated by the United States, and one where our industry maintains a net positive export balance, as been communicated here before today, is at risk of being outsourced.

I'd like to reinforce what's already been said this morning, but I'd also like to use two examples to try to illustrate my point. First, as part of our effort to grow the regional device industry, one of the things we do is we provide very early stage support to companies, and we try to get them to the point where companies like Pete McNerney will invest in them as a venture capitalist, as part of the venture capital community. We have noticed a very marked shift in the nature of the startup companies that are actually making it to the next step in their development. Two years ago, about 70 percent of the entrepreneurs that came to us asking us for help and to try to bring their company from an idea to a company were from the medical device industry. Today that number is about 45 percent, and it appears to be continuing to drop even though the total number of entrepreneurs coming to us for aid is staying the same or in fact even growing, potentially. The reasons that were given are cost, time to market, access to money, and uncertainty. More specifically, unpredictable regulatory hurdles and timelines are significant drivers affecting the reluctance of entrepreneurs to move ahead. Our device ecosystem is out of balance and under tremendous strain right now.

The second example relates to our international partners. Other countries and communities have recognized the importance of medical device industry as an industry that provides health benefits to their citizens and economic stability to communities. As one example, Japan specifically has made the creation of a medical device industry a national priority for the reasons mentioned above. The Federal Government is investing heavily in developing Centers of Excellence in medical device technology, targeting new knowledge creation as well as commercialization. In my observation, their academic, private, and public sectors are working remarkably well together in a very effective manner, and they are traveling the world looking for partners and collaborators, and they are putting tremendous pressure on their agencies to redesign their regulatory system, which I think all device companies would appreciate. Our organization, meaning the BioBusiness Alliance, is making a concerted effort to try to keep them focused on the United States, and Minnesota specifically, as preferred partners. By doing so, they can take advantage of our skills and our infrastructure to develop their end products; at the same time, we can continue to grow our domain knowledge here and leverage our -- their investments to advance our companies.

We have signed a memorandum of understanding with the Osaka Chamber of Commerce and Industry, OCCI, and with the National Cardiovascular Center in Osaka to be a preferred partner with them. Things had been going very well with that partnership, and they still are; however, the last time that I went and visited them in Osaka, one of the senior leaders at OCCI told me that they were getting more serious about trying to focus on Europe because they find the European regulatory system to be, and I quote, "easier to understand and more friendly to developing new devices." This was very discouraging for us to hear because over time we all understand that domain knowledge will migrate to where new products are embraced.

So, in closing, I'd like you to know that, those of you visiting us from the FDA today, that we recognize that economic security is not your primary mission; we understand that public safety and bringing new technology to market is. And I say this with all sincerity, that we can only imagine the responsibility that you and your team must feel and the political pressure that you must feel from Congress and what I personally believe is the outspoken minority that is constantly breathing down your neck and more than likely yelling in your ear as well. Nonetheless, we'd like to ask you to consider something, a proposal or an idea, as you leave and begin to modify your processes and protocols.

I think the best way for me to get my point across is to just use an analogy. When I was a young kid growing up on a small farm in west central Minnesota, we had a couple of very bad years in the early '60s where hail took out most of the crops of my dad's grain crops. At that time we had a building -- what you call a granary, of course -- where we stored the grain, and it was used either to feed the animals or it was sold for cash to feed the family. One of the bins that was in that building was set aside, and it's a place where my father put what he perceived to be the best seed that could be used to plant the crops the next spring. The bin contained our -- we all recognized it -- the bin contained our future, and we protected it from rodents, the elements, and anything that might cause the grain not to germinate and grow. And it didn't matter how difficult things got during the year, we lived by a rule that was passed down by my grandfather, which is it didn't matter how hungry the animals got or the kids got, you don't eat the grain, you don't eat the seed. It was because it was recognized that the seed grain was the only way out.

Dr. Shuren, we believe, the people in this room believe that with all sincerity that the device industry is one of the most fertile of all of our industries. As you consider its future, we would ask that you please protect it and be careful not to unintentionally eat the seed of our future by regulating in a manner that accelerates the movement of it out of the country. And we really offer our services to help and work with you in any way that we can.

So, with that, thank you for the opportunity.

DR. SHUREN: Ralph Hall.

MR. HALL: Good morning.

I'm Ralph Hall, primarily with the University of Minnesota Law School, where I teach food and drug law, life science compliance, and a comparative effectiveness seminar.

I'm going to try to make four points in 5 minutes, which for a law school person is a daunting challenge. But we'll get it done.

First point is perhaps procedural, and that is I think this meeting is very valuable and I would strongly encourage the Agency to have more meetings outside of the Beltway. These can be, for example, panel meetings, regulatory rule-making meetings, et cetera. For example, a cardiovascular panel meeting held in Minnesota would seem to be highly logical. That would help build bridges and also ensure that the people on the front lines, these in the room and people back at the various entities, both industry and academic and healthcare, have an opportunity both to contribute and to learn. And I think observing a panel meeting, for example, would be highly beneficial.

Second point is to build on a point that I made at the February meeting. I believe that we should differentiate as we look at whether it's 510(k) system or other potential regulatory changes, substantive changes and process changes. I think those are very different things. I'm going to concentrate on the substantive change area. My concern is that we are doing a ready, fire, aim, that we don't understand if there is a substantive problem with the 510(k) system, for example. Are we facing a safety issue or not?

Rather than just talking about that, after the February meeting I approached the Kauffman Foundation and have obtained a grant from the Kauffman Foundation to study the safety profile of products based upon approval pathway -- 510(k), abbreviated, special, PMA, whatever -- and we're in the process of that study right now. We're coding 20-plus data elements for recalls as the basis. We have no idea what that data will show. We hope to be done with data collection in 2 weeks. My point is not what the answer is; my point is that that type of information should be collected and used before we embrace substantive changes because I fear the law of unintended consequences and I fear that we may be addressing the wrong issues.

Along those lines, even outside the 510(k) system, there are a number of areas that require this type of dedicated study. All academics want more grant money, right? This includes areas such as the impact of regulation on innovation. It includes comparative assessments of U.S. and O.U.S., particularly Europe and Japan, in terms of how product review systems and regulatory processes affect safety, innovation, patient access, cost, et cetera, assessment of the value of specific regulatory structures as to whether they actually are adding value. And that also can identify gaps. Comparative effectiveness, a particular interest of mine. So the point here is let's make sure we have the data before we start making substantive changes.

The third point is to encourage FDA to ensure that there is adequate public input and comment before changes are being implemented. I know this is part of that process. I would encourage that very strongly. I'm a bit concerned with the rapid -- the timeframe between the release publicly of the first round of potential changes in the 510(k) system and then the schedule for implementation. To make sure that there's adequate time for public understanding, input, and comment on that.

The fourth and final comment that I want to make is to build on something that's been raised once before, and that is the perception that CDRH middle management is hamstrung and that reviewer decisions are unappealable or cannot be taken to management. This is both a culture challenge, I believe, as well as a substantive challenge. Now, there may be -- you know, the Agency may disagree that that is indeed the fact, but from talking to a number of people in Minnesota and elsewhere, it is a very commonly held believe that reviewer decisions right now cannot be in any effective way reviewed by management and that management will not touch that and enter into any sort of disagreement. The current processes for that are very cumbersome and seem to reverse the role of management and reviewer, and the culture that people observe from outside also seems to reinforce that concern.

So I hope that these comments are helpful, and again we appreciate your coming to Minnesota.

Thank you.

DR. SHUREN: David Hawks.

MR. HAWKS: Dr. Shuren and important FDA staff, we really appreciate you coming here today.

And give you a little bit of my background. I'm David Hawks with Invibio. We're a biomaterial solutions company. We work with a broad range of medical device companies, providing implantable polymers, and there's probably not a device space that we're not involved with. Besides my work with Invibio, I've had 25 years of field trauma emergency care experience.

We've got customers in over 70 countries. We've got over 2½ million devices that are using our polymer implanted in patients worldwide. There's over 200 510(k)'s with companies that have leveraged our materials. And in addition to our work with FDA, we've worked with regulatory agencies throughout the world, including SFDA in China and Ministry of Health in Japan.

Horizontally, our enabling technology is for medical devices. That's the bulk of our business. Vertically, we work with orthopedics, cardiovascular, drug delivery, neurological, spine, active implantable devices. Essentially, we work -- pretty much anywhere there's an implantable device, we're involved there. Specifically, we work with static and dynamic spine devices, neuromodulation and neurology devices, cardiovascular devices both for blood flow as well as heart rate, and we've got a lot of work going on with advanced articulating surfaces which hopefully will provide longer life for the patient and less invasive procedures.

I'd like to highlight an emerging growth company here in Minneapolis. They developed a medical device, they received a medical device excellence award. It's a minimally invasive delivered device, so less trauma to the patient, and it returns the patient to activities of daily living a lot quicker and hopefully drives a reduced total provider cost. This company achieved a 510(k) approval going back a bit of time, and they funded themselves internally without VC funding, but most of the companies we work with are venture capital funded or publicly traded. Had they not had the ability to have clarity in their FDA approval and come forth with a reasonable amount of data, they wouldn't have gone forth with this device. This company is very successful. They're growing at a very good clip. Based on early data from their patients, their patients indeed are returning to ambulatory life much sooner. And the total cost, from what we've heard, is much less. And from surgeons who are familiar with the device, they can do it with much less overhead.

We all wear a variety of hats, and thankfully today we don't have to wear a winter hat. I think last time FDA was coming into town, it was pretty brutal weather.

I want to talk about a variety of hats. So in addition to my 25 years of field emergency care where what I'm exposed to is the magic of the golden hour and how important it is to have the right therapy at the right time so that you can impact that patient's outcome and really impact whether they thrive, survive, or don't -- besides that, I'm a son. A number of years ago, my dad had an atrial valve replaced. And it was a traditional procedure. The valve went fine, but the complications of the surgery, he ended up in intensive care for 8 months. Didn't think I'd get quite so emotional. But if we had the therapy which we have today, which is transcatheter therapy, he wouldn't have as invasive a therapy. Likely, he'd be here. He'd still be one of my best mentors.

I'm also a father. I've got a daughter and another daughter, both of whom within this decade are going to college. I hope they take advantage of the university system here in Minneapolis. I hope that they follow, maybe in dad's footsteps, maybe differently. But the medical device community here is tremendous. College tuition is also a tremendous cost. If we get this right on our future pathway for regulatory approvals, they'll have an opportunity to have a great career, go to great schools, and stay within the biomedical field. More importantly, my youngest daughter scares me. She's fearless. It's likely she might need some therapy earlier on. If we don't have the right therapy at the right time for her, it could be a negative outcome.

I appreciate you coming here today, certainly appreciate the opportunity to address you. We look forward to a collaborative dialogue. I look forward to my daughters having a good career path and certainly appreciate the opportunity to talk further.

Thank you.

DR. SHUREN: Brent Ahrens.

(No response.)

DR. SHUREN: Then Dr. Susan Alpert.

DR. ALPERT: Thank you, Dr. Shuren.

Good morning, I'm Susan Alpert. I'm a Senior Vice President for Global Regulatory Affairs at Medtronic. For those who don't know me, for being honest about background, I also used to be them. I spent a number of years at FDA, including six as the head of the Office of Device Evaluation.

I really very much appreciate your coming to Minnesota and coming here first. Minnesota, as you've already heard from a number of speakers, has been in this business a long time. We have some of the largest and oldest companies, as well as some of the smallest and newest companies, because this is a very vibrant area for the development of medical technologies, so we really appreciate the fact that you recognized it and came here first to talk to us.

In the end, I think the most important thing, and it got said a couple of times, and I'm going to reiterate a few of those things; and that is that this is all about patients. In the end, it's about the patients that we all take care of. And that -- if we keep that in mind, I think we're going to be able to get all of this right.

You've already heard a lot of concerns that have been raised about current process and about the changes in processes and where this industry is coming from. I think until it's clear what those changes are, and until there is process in place, you're going to continue to hear those concerns; and I think we all have to deal with them.

Given the short amount of time, for those who know me, I am actually going to speak -- I'm going to read, which I don't like to do, but that will keep me on time. But I have five "asks," so let me tell you what they are, and then I'm going to give you a little bit of examples because I know Dr. Shuren you always like to hear examples with things, why are we saying some of the things we're saying.

So my five asks are for interactive processes; for clear messages; for predictability; for consistency; and for time to prepare. So the first ask is on interactive processes. As you contemplate the kinds of changes that have been talked about in 510(k), in PMA and IDE and in clinical trials, remember that this really does need to be an interactive process, not just a listening process, although this is a very good step to hear us, but we really need an interactive process. And one of the things that we've noted as the industry in the last year or so is that things have gotten less interactive. We're having less access for interactive process with the Center, so that's something that I think is very important that we pay attention to.

And also remember that although we're the regulated industry, we're also an industry that has a lot of experience and expertise, and that we should be used to help develop sound and ground new policies. For example, we can help you understand when you're developing a new policy what the impact on the industry is going to be so there aren't those unintended consequences. But without that discussion, there are many things that may not be appropriate that are changed. Simply, for example, adding a lot of new requirements to a lot of products may sound like it's enhancing a program, but when that can be done by focusing on specific questions and specific types of technology or specific areas, and get the same result, and that is making sure that any products that have concerns about safety become safer and that we maintain the effectiveness of products, that's important, so it's not how much you change, it's really the focus points of those changes, and we believe that we can, in fact, help you.

There's also the issue that, clearly, and you've heard it from many other speakers, that 510(k)'s are not all the same, that the products are not all the same, and the risks are not all the same. And focusing on where the risk really is is one way that we think would be very beneficial in how we change process going forward. It's also important that you recognize as you worry about safety and change, to focus on the things about technology that really can be changed and will be important and recognize that our technologies are not without risk and that there are some risks that are inherent in the technology or in the disease of the patient and we can't get rid of all of them. For example, hypoglycemia in diabetics who are on pump therapy is a real concern about the therapy. That can be addressed. But, in return, as the technology has evolved -- in return, there may be episodes of hyperglycemia. Let's put those things into balance. We have to worry about one because it has terrible consequences for a patient. The other is unfortunate and we need to pay attention to it, but it doesn't have the same risk for the patient. So we need to focus on where the real risks are and make sure that we're changing things that are important to change, but recognize that there are some things that we're not going to be able to change.

The second ask is for clear messages. Clarity is really important for us as an industry as you make changes. It's important for us to understand why you're making the change. It's hard for us as an industry to respond if we don't have the same vision, the same visibility and same understanding that you do of the data and your point of view. So, for example, the fact that health hazard assessments are not shared with companies, so that we can't see what you're seeing when you're reviewing our data, whether it's adverse events data or other post-market information, and we don't know what you are looking at or what you're basing your decisions on. That makes it very hard for us as companies to respond to the concerns, to respond to the questions, and to reach the conclusions that you seem to drive us or where you are trying to drive us. So clarity and what's driving you and a very clear understanding on what you're seeing in the data that we might not be seeing -- to your point, Dr. Shuren, you mentioned that you think you have a better view of some issues, and that may very well be true, but if you don't share them with us, we can't respond appropriately.

Another aspect of clarity is how we communicate with the public, how we communicate with patients. So clarity in the terminology that we use -- one example is when we call a correction to a device or recall in the press, and implanted patients worry that their device is going to have to be explanted, that it's going to require something on their part, when really it's a -- it may be a software patch, it may be something else that's going on, we have to get the language right for clarity with the public as well, and I think we can do that as well.

The third ask is predicability. Businesses run, as you've heard a lot today, on planning and execution. We determine what technology we're going to invest in with an understanding of when we're going to get a return on that investment. When requirements change and review processes change without visibility to the industry, we can't plan and that disruption is destructive both to technology as well as to companies, as you've already heard. It also leads to conflict between the industry and the Agency, which I think is a waste of time. So I think areas like -- a couple of examples: the pilots like the corrective fixes and the issues of escalation can be contentious or not, and it really depends on how well they are communicated. When the industry knows what the questions are, where the issues are, we can prepare the answers and we can all move on. When it is not shared and it's not predictable, a lot of time is misspent in conflict resolution. Changes to submission requirements, another example, is MRI compatibility information now being asked for in a lot more areas being put into a lot more labeling without an up-front discussion with the industry so that people were unprepared, leads to holding up submissions, leads to extra time. That doesn't have to happen. So, again, if we can avoid the unnecessary conflicts by having predictability both in -- when there is change as well as in the actual programs themselves, that would be very, very helpful.

Consistency: This is a large industry, lots of sectors, thousands of companies, lots of different kinds of products. We all need to hear about change, about what's going on at the Agency. We can't all attend all of the meetings, we can't read all of the things that are given to each of the sectors. So change needs to be very public, and it needs to be shared consistently, and it needs to be done across the sectors. Another aspect that becomes problematic and contentious for us is when changes are being made within an area, but they are being made submission by submission. When a submission is made and the reviewer starts to ask questions or change the requirements in a submission, the requirements in a technology, labeling, and other types of information, and it's done submission by submission, you may not realize it, but you are disrupting the industry and the marketplace. And I know the marketplace is not the FDA's concern, but where you adversely impact the marketplace, it can be a fault, and it can be your fault.

So, the issues that need to be shared need to be shared broadly and consistently and in a timely way with everyone that's going to be impacted, not just the submitter that's in front of you now because the person who's got the next submission, who's ready to put it into the Agency, needs to know that same information, as well as the people who are developing other technologies. And that's just not happening as well as it could.

Another area in consistency is: How do we maintain our products in the marketplace? You know, one of the things that's been happening is just because we can improve a product, because we can make it better -- we can make it safer, we can make it more reliable -- doesn't mean that the previous products are unsafe or ineffective. And, I think, having a consistency in how that's understood, how do we understand what safety and effectiveness really are at this point in time -- where those thresholds are -- is very important to all of us.

My last ask is time to prepare -- Ralph Hall mentioned it as well. In this industry, we have a lot of experience in change. We know how to respond to changes in technology. We know how to respond to changes in the health care environment. We know how to respond to changes from regulators as well. The EU has only been regulating us for 15 years, and we all changed and managed to work our way through getting CE mark. Japan, five years ago, made significant changes in their regulatory process, and we were able to respond to them. We were able to respond because there was lead time. There was clarity and there was lead time.

So my last ask is please make sure you give us lead time in order for this industry to prepare for the changes. We recognize that, as an industry, we have made a lot of changes to medical devices in the last 40 years. This is not the same industry it was when the regulations were initially written, and the process and the programs have had to evolve in order to stay current with, actually, the vibrancy of the innovation that's well represented in this room. But, at the same time, we have to be able to work together to make this work well so that you can fulfill your two missions, both protecting the public health and supporting innovation that, in fact, improves the public health.

So those are my five asks: interactive processes, clear messages, predictability, consistency, and time for the industry to prepare so we can meet the new requirements where they are appropriate and when they are appropriate.

Thank you.


DR. SHUREN: I would like to thank all the folks who came up to speak. At this point, we are going to take a break. We are a few minutes ahead of schedule. It is about seven or eight after 10:00. We were going to go until 10:15, so we are ahead of schedule. From a person who shows up to meetings usually ten minutes late, this is a major success. Why don't we start up about five minutes earlier, so we keep extra time for questions and answers? Why don't we meet back at 10:25, in the room.

(Off the record.)

(On the record.)

DR. SHUREN: First let me thank everyone for how quickly you actually are getting to your seats, and I only asked once. If I can only get people at the FDA to do the same thing because my staff just routinely ignore me.

This session, as I mentioned, is yours. You can come up, you can talk about anything you want, raise any issue you want, ask any question you want. You can ask a question just generally, and anyone here can answer it, or you can direct it to a specific person. All I ask is that if you do have a question or something you want to say, please come up to one of the mikes, introduce yourself, say who you are, who you are with. And I would ask, if you are going to talk about an issue, to try to keep your comments brief just to allow for enough time for other people to have their say as well.

So, with that, I am going to open it up for questions and comments. And there is a prize for the first ten people who come up.

MS. PAPPAS: Is the microphone? No, it is not. The microphone is not -- oh, there it is.

My name is Kimberly Pappas. I am with the Minnesota Department of Health. I am a state regulatory agency for radiation control programs. My concern is that the FDA has misplaced priorities. In the President's Cancer Panel, one of the FDA initiatives was to have "smart cards," and this is an initiative. And this is so patients can track what kind of radiation exams that they have had. In the meantime, state regulatory agencies are not being notified by the FDA of 510(k) approval of emerging technologies. So what happens is we get a phone call that says, you know, "Is this product legal in Minnesota?" "Well, I will have to get back to you because we are going to have to do some research on it." And research is very difficult because we not getting the information from the FDA, and we are not getting it from the companies because they consider it proprietary information. So my comment is we really need better communication, especially electronic communication, from the FDA, so that when you get one of these 510(k)'s approved, and I do know that it happens because we have seen things like electronic brachytherapy and radiation therapy, O-arm technology -- which merges CAT scan and fluoroscopy technology. So when you get this approved, that you notify the state regulatory agencies, "This has been approved," so that we can start doing the research now rather than later.

DR. SHUREN: It's a very good comment in terms of updates. Now, we do put -- our information obviously goes into our databases on the website, but that is much more of a challenge to get the information. We do have listservs as products actually do come out -- a number of those do come out through the Agency. So one thing is, afterwards, to make sure for relevant listservs we do have you on it. We will also go talk about "Are there ways for that information to get out in a more useful manner for the states?" in terms of how they are plugged in. And I will turn to others here if they have anything to add to that.

And I also notice they are all shifting a little bit to the left, so I -- well, we will switch back and forth.

MR. EISNER: Thank you, Dr. Shuren.

Walter Eisner is my name. I am a writer for an orthopedics publication. I have a question about predictability and transparency. You have established task forces to look at those types of things. However, in the actions you have taken, as an Agency, since the change of administration, there have been a couple of cases where the transparency and predictability has been hard to see. One is the situation of the dynamic stabilization devices for the spine, and you asking for follow-up information on those from cleared devices alrea dy. And the ReGen Biologics situation that was cleared with probably the most -- no device has ever been cleared that had more scrutiny of it than that, and you did a do-over with the FDA panel. Are these -- are we going to see more of this, or will the task forces you've described, are they designed to stop that from happening in the future?

DR. SHUREN: Well, just so -- just so I am clear, in terms of just to clarify for me the exact fact, dynamic stabilization systems was a case of exercising our 522 authority. We had seen certain problems with some of the devices, and we said, "We need to get more information on this." And then ReGen, the Menaflex device, is a very unique scenario. So, just to help me, so I can answer a question, the thing that you would like to see that's different?

MR. EISNER: There was no apparent scientific evidence. There was no evidence that there was any -- in the ReGen case -- there was no evidence that there was any scientific problem. There was no evidence that the company did anything wrong. In fact, your own report said that the Agency mishandled how it was done, yet this company is basically out of business today because the clearance that you granted is no use to them because no physician will touch their product. So that's the one I am interested in.

DR. SHUREN: So ReGen, specifically, and for folks to know, this is a very, very complicated story. And it is actually a rare time -- it is the first time I have ever seen something like this, where the Agency actually went back to review what itself did in such detail. And the issues around it were concerns about was there undue influence on the regulatory process for when the Center actually made a decision? This is a case where the Center, several times, actually had decided not to clear the device and on the last time in fact did. A report is available, if you have not seen it, it is on our website. It is a very detailed report that lays out what the reasons for undertaking that particular evaluation and what was found during that evaluation. And the conclusion was that there was pressure brought to bear, and it was unclear whether or not that actually influenced the decision. And so the Agency made a determination to go back and then revisit the record, and it is supplemented with a panel meeting that was held several weeks ago. That was done to assure the integrity of the regulatory process, because if that is compromised, it undermines the decision that's made, not only on that product; it actually calls into question that process for other products coming through. And so one of the steps was to reevaluate. There are other changes that came out of that assessment as well, all the intent to actually improve the regulatory process and assure that decisions that are made are actually made by the scientist based on the data and should not have influence that occurs outside of that particular process. That's what ReGen is all about. It is not something that you can expect to see as regular course of business for the Center or for the Agency.

MS. BRITTLE: I am Maria Brittle, and I am regulatory director at NexionMet Systems.

My question is probably going to be predominantly for ODE, and I am going to use examples from the biocompatibility area. So, briefly, for biocompatibility, we always consider ISO 10993 Part 1, and there's also FDA's Bluebook Memo on this subject, which is fairly old at this point. And I work predominantly with cardiovascular group. So, some time ago, for the hemocompatibility subtests, FDA started requiring complement activation testing for transient devices. It was like two years before this ever appeared in a guidance. And so -- I know it was two years because I questioned it when I saw it in the guidance, like "Oh, what's this all about?" And she says, "Oh, we've been requiring that for two years." Then when I asked more about "Well, why do you want complement activation testing for a transient device?" The biocompatibility contact said, "Well, it's due to anaphyl actic shock." Well, in my own mod research, which was of more recent data, that appears to be a very remote risk. I do think they had something on a drug-eluting stent. And then the only other really frequent occurrence I saw was with a catheter, but the problem was post-market, something had been changed in manufacturing. So, in either case, the drug-eluting stent, that doesn't really have anything to do with the delivery system. And a post-market change doesn't have anything to do with a pre-market requirement. So I am still kind of unsure as to why FDA thinks it is important to have that testing, but it has now become pretty standard, at least in cardiovascular.

The other odd thing is, in our particular situation -- this was with a previous company -- FDA review group would have accepted our clinical data in lieu of the complement activation testing. Well, that was 250 patients, and scientifically that wouldn't even pick up a remote event. So I am not seeing the consistency of science. Now, more recently, in the new stent guidance, the newest one, genotoxicity has been added for transient devices. And I think this is still at odds with ISO 10993 Part 1, where it's only required for implants. So I did call the guidance contact and asked, "Well, why are you adding this and why isn't it in the 2008 PTCA Guidance?" And she e-mailed back that, "Oh, we're putting it in the PTCA Guidance." Well, of course, that's not imminent; they are updating that but we don't know when it will be out. And she did not give any explanation as to why FDA believes genotoxicity is important for a transient device.

So this is the kind of moving targets we work with, where things are added. They don't necessarily make sense to us, on a bigger scale, of like looking at ISO guidances where a lot of big experts sit down and decided things. And at least when it's a guidance, you know that, well, at least the whole group agreed on it. But sometimes you don't know if it is just the reviewer thinks this is a good idea. So my question for ODE, it seems to me that part of the problem is a lag in the guidance documents. That's a lot of work to create one, or to update one. So could each review group have a webpage where they could post any new additions that the whole group has agreed on? Because one, you would know if it's only an oddity of the reviewer and you could ask more questions; but two, people would have open and quicker access to some of these changes than they are going to get in a guidance document. And, along with that, I would want to see the rationale. "Why do you want genotoxicity testing for a transient device? What's that all about?"

MS. FOREMAN: So I do agree with you that our guidance process is somewhat labor intensive and that oftentimes the publication of the guidance lags our initial requests for information. We currently are looking at ways to streamline our guidance process to make it less cumbersome. And, as Dr. Shuren mentioned, we have hired some policy analysts that will hopefully help write -- because, what happens is, to write guidance, we actually take our reviewers away from reviewing work so now your submission review times suffer. So we are trying to tackle that very complex problem. But I do agree with you that we should be transparent in our requirements. I will say that, in some cases, we do -- even though it is a remote risk -- what we ask for is we do ask for bench testing because we know that we will never see that clinically. And we know that we will not -- not that we won't see it clinically -- but in your clinical study, that event won't pop up with sufficient event rates for us to actually determine the true consequence of that failure mode or that problem. The other problem is our post-market data that we get is difficult to rely on because we never have denominator data. We don't know how many devices are in distribution. So if we become aware of a problem, we may start asking for bench testing, which we find to be the least burdensome way to address that issue, so that we can make sure that we are putting a product on the market that is safe and yet effective.

And I do hope when you called the contact for the guidance they were able to give you the rationale behind the request. And I will tell you that I am very hopeful that PTCA will be out very, very soon.

MS. BRITTLE: Okay, well, no, they didn't provide it. And I had specifically asked, "Well, what risk has been identified that would warrant this testing?" And that was not answered in the return e-mail. And I am glad to hear the PTCA Guidance will be out soon because you can imagine there could be PTCA catheter submissions about to go in, even at this moment, and they have no idea that they should have done genotoxicity testing. So there are going to be some of those unhappy people if that question comes back.

MS. FOREMAN: Okay, I will make sure I go back to my staff and ask that when they respond to answers, that they not only give the answer but they give the basis for the answer. Hopefully, that will clarify.

DR. SHUREN: But this issue about if the Agency or the Center has a change in expectation, there's always an issue about what should be the basis for changing its expectation, but once it's made that, it's changed that expectation, communicating it to the public. This is one thing that will be addressed in that new science report. And I will tell you the conundrum that we deal with. It's what we are able to provide publicly through what process. So, as you know, we had rule making, and that imposes a requirement, and it is a beast to do a rule. Having done it for over a decade, it's hard. So the next step was guidance, and guidance, more bells and whistles have been put on the guidance process, and some of that is not from FDA's doing -- and I don't mean to cast aspersions on the people who may be here from the Hill -- but there are requirements that we need to go through. And so the guidance process can be fairly lengthy. And then there is review that goes on, and sometimes outside of the Agency. So the next step is could we actually say something without going through the guidance process? And now we get into that situation of we stop providing more details, we get told, "You're doing guidance and you're bypassing a process that you must go through." And that is what we are trying to work through and balance, and that's the big limitation for us. So we are looking at mechanisms where we might be able to at least signal what our thinking may be and get people in the door to talk about it so that we're compliant with current law, but we're able to notify people as quickly as possible because a company should not be out there when we change expectations and you don't find out until you send us a submission. That's not good for you, it's not good for us either, and we're trying to find what the right balance is.

We'll alternate.

MS. TAY: Hi, my name is Sew-Wah Tay, and I am a regulatory consultant in the Twin Cities.

And I just want to kind of want to make a note that in the last year, within my clients and outside my client group, we have seen a significant increase in NSE letter from the industry. And reading through the history of the NSEs that we have been receiving, the rationale for the NSE is often not -- is given some broad generic language, your standard language, that did not appear to be even logical. For example, one of my clients got an NSE letter for endoscope. And endoscope has guidance that is pretty standard and is even for third-party review. And looking through the questions -- it had a new reviewer, and the reviewer was asking a ton of questions out of curiosity and not because it is relevant. They were just asking for their own -- seems to me they were looking at asking the questions for their own educational purposes. But because of that, the time -- you know, the regulatory time clock was taken up by that because all these questions were coming through AI letter and he got an NSE. So that's kind of one of the trends we've seen. I have seen that in at least three submissions in the last year, that the questions have nothing, absolutely nothing to do with the device, but really more of an educational process for that.

Another issue that we've actually seen is that while waiting -- there's so much noise and information about FDA reviewing the 510(k) process that it appears to me, from sitting on this side of the fence, that the reviewer is being proactive and imagining what those changes are and taking that into their own hands. Because the way 510(k) is being reviewed right now is very different. So I do not know if they have been given different instructions. And if they have, would it be possible that at least the industry knows about it because between now and next September, it's still, you know, over a year, and what do we do right now with this unpredictability of what to expect and what kind of data to expect? An example, I'm working on a cardiac arrest device, a life-sustaining device for cardiac arrest patients. And all the questions have been about what would happen to your patient's sense of smell. I mean, we are talking about trying to save a patient's life where in cardiac arrest the patient's survival rate is like less than 30 percent. You know, it's a total imbalance of the kind of questions that we are getting.

Thank you.

DR. SHUREN: So, to answer your question, there have not been new instructions to the reviewers as to change practices. And we have heard this about, "Are there individual reviewers who may be interpreting things differently?" We've heard that go around. Asking questions that maybe are not considered relevant may be of interest to learn. We have heard that before. It is part of what we are looking at in the assessment. It is one of the reasons that we are doing the assessment. We could go, just based on we hear a few things -- and, I will tell you, I hear things from people within the Center, too, about their concerns and issues, the challenges they have had actually implementing the statute and applying it to some devices, and some of their interactions with industry and taking it from their perspective. And they have a somewhat different perspective in some cases, too, and I don't discount that. And all of it, what we're trying to do is not only hear from people to the extent there is data that can let us know, is there a problem or not, and if there is, what's the root cause? Because if we are going to take any action, we want to make sure that, first of all, there is a problem; and secondly, that we address the cause of the problem and that it is not a band-aid.

And so you see us taking, for 510(k), two approaches. One is a look outside of the Agency. Always be those questions about if the Agency just takes a look, are we giving it the fair assessment? We're willing to say we'll have an outside body -- and we know that's got its challenges because it's their process, they decide who sits on the committee, and they'll come back with our recommendations. After we tell them the broad charge, it's no longer an FDA process. That's good and it's bad. But we look forward to what they will come back from the Institute of Medicine. At the same time, we have our own look underway for the following reasons. We need to do our own homework. We are not being good government if we don't do that.

But the second is a timing issue, and here is the conundrum. On the one hand, you want to look and you want to have information and you want to make informed decisions. At the same token, the longer that goes on, the more uncertainty is out there. And it's not just for you. It's for our people inside the Center. What we're trying to do, whether it's the right thing or not, is to split the baby a little bit, and we have our own process that is moving so quickly, specifically for that reason, that we don't want to take another year. If there are things that we can identify, and if there are things that we should be doing today, then we should move on that, if those are the things that make sense and we have general agreement to do it. And those would be the things that we move on more quickly. If there are things -- and I'm saying if that comes up -- that may be more controversial, that requires further vetting, we need to take more time on that. And that is the split that we are doing.

In the interim, we do have this period of continued uncertainty. I will tell you, from some of the data I have, it shows problems that have been going on, or changes and practice that maybe are going on for several years. And you just -- and you are seeing maybe more of it now. There are issues about NSE, and I have seen what the NSE rate has looked like for the past few years. And that doesn't tell you if you're right or you're wrong. You need to drill down further, but it is a trend. And that trend has been actually going back several years, of an increasing percent of NSEs, or NSEs and withdrawals, we are actually seeing a drop in the SE decisions. And so we are looking into that as well. But all of it is trying to be based upon information and make well-informed decisions.

I will tell you a challenge that I am facing. And I am rambling on, because I do want to put this out there. CDRH has about 1,300 people. So, it's -- in terms of the device industry, we're a big company. And that, itself, running that big company, has its own challenges. But the other thing is we're not probably big enough. When you deal with an expert, you may be dealing with the only expert in the Center for that area. Particularly in the medical fields, if I have an expert, I usually have one. Once in a while I have more. In some cases I have none. And that becomes very challenging to run that program. Without the depth, if somebody leaves, you are caught in the middle with a change in people handling that review because you don't have the backup behind it. As I tell people, I have a pretty good starting lineup. I have some superstars. I have some people who are solid. I have no bench, absolutely no bench. And that has implications for device review, the challenges, has implications when we provide feedback on clinical trial design for IDEs. It has an impact when we produce guidances. Guidances take resources, and to do that, one of the limitations are the people. So, we work within those constraints. We have been working -- we have been lucky, I will tell you, in the past few years, to be getting a little bit more money. That's come some from user fees, some from Congress. But at the same token, I should tell you our costs go up at about 5.8 percent a year, believe it or not. Because we got security that we pay for, we have rent we pay for, and we have the payroll benefits that are mandated we go through. And it winds up driving to a set increase of around that rate. So, if our funding goes up, and it goes up by that amount, I stay about the same. If it's a little bit less, it can turn into an effective cut. I am not here to complain. I am here to let you know the reality we deal with, and so when we revisit, we try to say, "If this is going to be the way things stand, how do we design our business processes to do the best we can with what we have?" And then everyone has to understand that that's the playing field that we are all working off of.

MS. FOREMAN: And if I could just follow up on the NSE. It sounds like your NSEs were performance-based NSEs, so it wasn't an NSE based on lack of predicate or a new intended use or a different technology. Part of MDUFMA negotiations indicated that we would reach a final decision on our 510(k)'s within a certain number of days. With that, an NSE is considered a final decision. So with that, we're not trying to surprise you. So if you see two letters in a row, or two correspondences from the Agency asking the same question, I would encourage you, if you don't understand the nature of that question, why that question is being asked or what the relevance is, to please call your branch chief, call your reviewer, call your division director. Because if we're asking the same question a couple of times in a row, that might be setting up an NSE because if you don't respond, we're going to say we couldn't assess the equivalence of your device. So that's our way of trying to be transparent is that we're saying, a couple times, "We need this information." And if you think it's inappropriate, please call your branch chief, please call your division director, please call your reviewer to inquire as to why they need that information.

MS. TAY: I would like to say that, in that instance, we did call the reviewer; we did try to talk to the branch chief. And I think because the reviewer was new, it was said that you cannot -- we can't even talk to you. We asked for a meeting. He said they wouldn't talk to you. And the questions are not the same, and that's kind of what was frustrating was that none of the questions were related and it's not the same. And it really is more informational. They were not asking for more data. They were asking for information about other devices that was used in conjunction with this device and wanted us to find all the regulatory information of that device. So it was -- you know, I mean, we -- and that was what was difficult was that the AI letter that we came in has nothing to do with our device. It was quite unrelated. And I do not know if there is an appeal process, but we did talk to the branch chief about it.

MR. HAWORTH: I'm Bill Haworth, the president and chief technology officer of a company called PlaCor, based in the Twin Cities here, a startup with a diagnostic device under development.

We have a protracted history of trying to get clearance to market for this device. I don't want to go through the details of it, but we've been in discussion with OIVD for three years and don't have clearance. There has been a very noticeable change in how the review is conducted over those three years, going much more from, as we started off, a straightforward determination of "do we " to the predicate, to a much broader and general and more open -- open-ended questions towards the end. And so while I think we are very generally in support of clarification and improvements in the process at the Agency, our concern is that a lot of these have already been anticipated in the review staff. And whether they've had directives or not, I guess they're people, and we certainly are being examined on this in a very different way than we were three years ago.

I have another point I want to make, but I will let you respond to that first one.

DR. GUTIERREZ: I can respond to that. I think the history with PlaCor has been long. It has been a difficult one. I actually think that the Agency -- the history with PlaCor has been a long one. The Agency actually has spent a lot of effort and time. It has not been an easy one. You have a technology that is quite different, and there were some concerns with that and with the intended use. And, you know, I think this is actually an example where the Agency has tried very hard to help, to help the company come up with the niche that would make sense and has been difficult for the Agency to say, in some ways, we have a hard time saying that we don't see a way forward on this. It's -- I do think, in your -- I actually don't think that this is good example of where the Agency may be asking different things. We have a history in OIVD, actually, of helping small companies. But our biggest problem, sometimes, is going too far. We are not entrepreneurs ourselves. We actually tend to like to see new innovative devices come to market, when we can find a way to place it on the market in a way that we feel that is safe and effective. And sometimes, perhaps, we don't have the necessary sharpness, if you like, in terms of business acumen or whatever, but in this case, I really do think that we tried very hard with PlaCor. This was a case in which, you know, one could argue that the Agency actually spent a lot of effort in trying to help a company at the expense of doing all the things that we could be doing.

MR. HAWORTH: Well, I don't want to get into a sort of blow by blow issue of that because that's not appropriate for this meeting. But I think there certainly has been a great drift towards much more general concerns in the questions that are asked over the course of those three years. And it is as if the reviewers and review team are really anticipating changes, that we are sort of hearing bits and pieces about in presentations like this. And I think it's really important for the -- this is going to -- what you're talking about today is great, but it isn't going to happen for two years or three years. In the meantime, everyone's got a -- you've got a business to run at the Agency, we've got businesses to run here, and so we need to know that we can run those along whatever are the appropriate guidelines.

And I wanted to raise one other issue because it's been a real concern for us. I don't know whether you call this transparency or not, but when a reviewer or a review team comes to a conclusion and presents it to us, however, it's our experience that that is completely unshakable. Now, you know, the review team may be right, but it is not open to challenge on any sort of basis, scientific, technical. Basically, they've decided, and that's it. And I would really urge that your review teams are able to maintain a more open approach to this and imagine that they don't always reach the right conclusions first time out.

DR. GUTIERREZ: Let me address that.

And I don't remember, in your case, don't actually -- but we actually do try to make this an open type of situation. If you don't agree with us, we often give you the opportunity to -- or we often do it ourselves -- take the questions to panel meetings and usually give the companies the choice to go to panel or not, to ask those questions if they don't believe the Agency is actually on the right track. I hope we -- I don't remember if we did or not with PlaCor, but --

MR. HAWORTH: You have offered us.


MR. HAWORTH: I will just give you one specific for that, and then I will sit down and let other people talk. Just so you know there's a real issue. We were told at one point that a proposed intended use statement that we had made was considered high risk by the review team. We tried to get ideas of why that was a high risk indication for use, because none of our risk analysis suggested that, and just could not elicit that from the Agency. And that's what I mean, and you may be right, but we don't get a chance to challenge it if we don't know what the basis is.

Thanks a lot.

QUESTION: I promise I won't ask you a "Have you stopped beating your wife" question this time.

DR. SHUREN: The answer to your question is "Yes, I have."

QUESTION: Okay, I got two questions. They are kind of softballs. One is, I think I read in your plan that there is going to be a director of innovation, and I didn't hear anything about that this morning, and I would like to hear more about that. And, secondly, your predecessor was beginning to have some conversations with Dr. Phurrough over at CMS because, as the VCs know, getting approval of the device is just step one. Getting payment is another. Are there any plans to have any kind of conversations with CMS on payment issues and how the trials are designed so that they qualify for payment later? Is there any bridge going on there? So, those two things.

DR. SHUREN: So the first, in terms of a director or coordinator for innovation, the answer is "Yes." We will be looking to bring someone on board to help us in these efforts that I was talking about, someone who can really devote their time to this focus, and that will be at a high level. We will have a whole bunch of other people already being pulled to help us in that initiative.

You raised, in terms of CMS, with discussions previously, you know, with Steve Phurrough, and actually part of my career, I was at CMS. Steve and I were division directors together. And Steve has actually went over to AHRQ, and then he's since left government. We continue to have a good working relationship with CMS. We don't get involved in reimbursement decisions. We are very clear about we have separate missions, and those missions need to be separate. What's kind of a question on the table, though, is from the standpoint of the products we regulate, can we be looking at pathways that I really consider the access to patients. That you can have a product that gets -- we can approve or clear a device. If that's on the market, if it's not reimbursed, or you don't have adequate reimbursement, do patients really have access to the technology? And in some cases, no. One of the things that we have on the table for this Council on Medical Device Innovation is looking at, at least for starters, where we have targeted there's an unmet public health need, we should have devices in that space, and that may be something new, or that may be redesign of something that's out there to meet that need. Can we look at things just like that, more of a glide path from FDA to reimbursement? Can we work on those things? Can we sort of leverage some of the tools that maybe CMS has that would allow us, even from our standpoint, to have a product that comes on the market? Those are the kinds of issues we have on the table. It's something we're going to be looking to get feedback on, so when this council -- which has been set up, we've already met -- we will be going out to the public to get feedback and this is one of the issues we would like to hear about in that dialogue.

MR. STASSEN: Dr. Shuren, Dave Stassen with Split Rock Partners, Minneapolis, nice to see you again.

I would like to ask a question about consistency or fairness within the Agency. Split Rock invests primarily in medical device technologies. We have probably 40 companies in our portfolio that are either 510(k) or PMA companies. A curious thing about two of them. They have both been in life about the same amount of time; they've both been eight or nine year. Both are PMA track companies. They've both done fairly extensive clinical trials, one in the cardiovascular space, one in the respiratory space. One company did an 800-patient clinical trial; the other did a 300-patient clinical trial. The 800-patient clinical trial met all their endpoints, they had a positive panel recommendation, and with either meeting or exceeding their endpoints. The other company did a 300-patient clinical trial. They met their endpoints but were somewhat equivocal. The final analysis was the 800-patient company ends up saying, "We have to do another trial to confirm things." The 300-patient trial got approval two weeks ago.

So, the question is how do you ensure fairness across divisions, number one? And number two, how do you -- or what is -- or is there an appeal process or is there an escalation process that we could use to ask for is this fair or not?

DR. SHUREN: It's a great question because you have consistency when you make a decision regarding the same kind of products, but if we're actually implementing the same regulatory standard, and we are dealing with -- if we have common science, shouldn't we be consistent in how we deal with that, then, across products? That is -- and I know all of this, you would love to have the answer, to hear exactly what we will do. And so the value of having this meeting here first is we have it here first, but it's not in the process where I am going to be able to tell you exactly what we will do. But this is squarely on the table, that how we do things today is not sufficient to address that concern on consistency. So there are things that we at the Center will need to change to do that. And we are looking at a variety of different mechanisms to potentially accomplish it. In the interim, there is appeal opportunity on decisions that I would take advantage of. We're also going to be revisiting what we have on the books for appeals because the processes there have been -- they are rather outdated, and so one of our goals is to actually update them. So I would take advantage of that. But we do anticipate we would be making some changes to address that concern of assuring consistency, not only in the decisions made in an individual branch, but across branches and divisions.

MS. QUINLAN-SMITH: My name is Ann Quinlan-Smith, and I'm the president of Alquest. We're a consultancy and CRO that's based out of Minneapolis or headquarters out of Minneapolis. And, as such, we have visibility to trends that are going on with companies in the industry. And we are seeing a much higher level of rigor on the clinical -- the clinical data requirement side. We've got situations where FDA has required statistically derived sample sizes for 510(k) products, confirmatory studies for PMA products. We worked with a group that refused to accept a large amount of data that was collected outside the U.S. because they wanted to see a clinical study conducted in the U.S. We are also seeing 483s being issued to clinical sites for deviations and things that have been found and documented. And I am just kind of wondering if you can comment on why the level of rigor is increasing on the clinical side?

DR. SHUREN: I think -- first of all, when we have heard it, one of things we would like to do is to drill down on specific products. So, to the extent that people are comfortable, and I do open the door if there are specific cases and we can get examples, that's helpful to us. I do think one of the things that has happened within the 510(k) arena is, over the time, the kinds of devices that have fallen under that bucket have increased, and the complexity of those devices have increased. And I do think there has been an effort on the part of the Center to make the 510(k) program as broad as possible to encompass, recognizing that, if not, what's the other available alternative? It's de novo. And I think you've heard from people about some of the problems with de novo. De novo is also on the table of what we're looking at as part of our 510(k) review because we have had challenges with de novo as well. So I would anticipate that you will see us commenting about it. And then, of course, the other is it's class can be under a PMA. As a result, though, you have these instances where people may feel the lack of comfort with the technology, that maybe should it fall under 510(k), and if so, how do we actually express those data needs? And what we're seeing is probably most of the issues are within those particular devices where there are -- clearly where there are clinical data requests. And some of the uncertainty -- and that's uncertainty, I think, within the Center as well, about where those devices should fall if they are in 510(k), being very clear about what the data expectations would be. And, if not, should we be making better use of the de novo process? And then, can you have a de novo process that is more usable than what we have now, which is you go through, you get the NSE, and then, from there, you will come on the market if we set special controls, and those often they've got their own rule making process to go through, and you can imagine not only the delay but the amount of effort it takes to go through that process, and that makes it a very challenging one. Those are all squarely on the table that we clearly need to address.

MR. SILVERMAN: I would like to add to -- just comment with respect to increased oversight of clinical investigations and sponsors. I have fairly close contact with the biological monitoring program within the Center, and I agree there has been close oversight. I think that the BIMO program has been active since its inceptions, and I think that it's growing and becoming increasingly active. My own perception is that that's totally appropriate. It is critical that we assure the safety and welfare of patients who are involved in clinical trials, and it is equally critical, if not more so, that we ensure the integrity of data that those clinical trials produce because, but for that integrity, the Agency's decisions are predicated potentially on false information, which can be disastrous. It is a challenge and will be increasingly a challenge to address clinical trials that occur outside of the United States. It's simply, from a resource perspective, harder for us to monitor those trials. That's not to suggest that we will interfere with O.U.S. clinical trials. There are good reasons for those clinical trials to be conducted worldwide. We need to look internally to determine what steps we can take to better monitor those clinical trials when they occur in other parts of the world. And to Jeff's point earlier, in his presentation, we need to align with our foreign regulatory partners so that we can rely upon their oversight as well to enhance our decision-making.

MS. DUNCAN: Hello, I'm Elaine Duncan from Paladin Medical, and I think Dr. Foreman can answer this question.

I heard you mention previously the negotiations with FDAMA, and this may be rooted in that. Basically, what had occurred recently was in fourth quarter last year, or your first quarter of the fiscal year, we happened to submit a 510(k) right about that time. After being polite and waiting for just about 90 days, when we hadn't heard anything from a reviewer, we started tracking the submission, and actually went through the small business group to track our queue. And the lady there was kind enough to inform us that our 510(k) had been put into a tier 2 review. I tried to inquire about the tier 2 review. Now, I've been in the biz a long time, and I remember the old tier 1/tier 2 program and did all sorts of Googling on FDA's website and throughout any of document that I could find. And the only thing I came to any kind of FDA reference to a tier 1/tier 2 510(k), in the recent era, was a comment made by Dr. Tillman in a presentation about FDAMA and tier 1/tier 2. And this had to do with the percentages of 510(k)'s that would be cleared within 90 days and the others would be cleared in 120 days, and that categorization was loosely referred to as "tier 1/tier 2." So, as a part of this opportunity to express the need for a communication and clarity, I would like to ask, in future, when a 510(k) goes into tier 2, who notifies us, and why can't we find out, and why didn't the reviewer or the branch chief ever answer any questions as to why the 510(k) was classified class 2? Who did it and when can we know about that? And is this truly policy, or was I in a time warp?

MS. FOREMAN: Okay, so the answer to that, your research led you essentially to the correct answer. Our performance goals are 90 percent of the 510(k)'s will reach their final decision in 90 days. Ninety-eight percent of the 510(k)'s will reach their final decision within 150 days. So, just the matter of the process, if we miss the 90-day mark, that automatically puts you in tier 2. There's no magic in assignment when files come in, we say, "Oh, that's a tier 1, that's a tier 2 file." We strive with every file because 90 percent have to meet the 90-day goal. We don't have the margin to start categorizing files. So when every file comes in, we automatically assume it will be a tier 1, 90-day review. Obviously, if we miss that goal, then it defaults into tier 2, and then we do have a 2 percent margin for those complex devices that might not reach that 150-day goal. And, you're right, we don't actually communicate to the sponsor that, okay, 90-plus FDA days have elapsed, so you are now in tier 2. You know, I don't know -- we can look at our processes to find that, but by default, if we've missed the 90-day goal, you can bet money that we are trying really hard to meet that 150-day goal. We are posting our current performance scorecard measures on our website, so you can see our performance currently. And you will see that recently it hasn't been where it should be, so we're suffering a little bit. And I think, you know, your file is probably a reflection that we are having difficulties meeting our performance goals.

MS. DUNCAN: So, to clarify, then, the small business group was a little bit incorrect in the idea that it had been predetermined to be a tier 2 product. It only fell into that -- and I happened to call after it had fallen into the secondary pile. There isn't a triage or a prioritization of 510(k)'s now as there were in the old tier 1/tier 2 program?

MS. FOREMAN: That's correct. Everything that comes in is assumed to be a tier 1, 90-day, 90 percent goal. With our PMAs, we will occasionally target one as being a tier 2. We have the same type of performance goal with PMAs. And, basically, if we know we have to take a panel -- or a PMA to panel, we are not going to be able to meet our tier 1 goal for PMAs. So you can kind of guesstimate, if you have to go to panel, you are likely going to meet the secondary goal for PMAs. But there is no such prioritization with 510(k)'s.

MS. DUNCAN: Well, I can say, at least, that the review process, once it did happen, happened very promptly, so at least everybody can relax about that.

DR. GUTIERREZ: Yes, the one thing about that one is you should actually be asking questions before the 90 days, and the reviewer should have been actually communicating with you before that. So if you are not hearing from the reviewer, if you're not hearing -- you need to press the manager. If the branch chief is really busy and doesn't get back to you, go up the ladder and just ask, "Where's my file? What's going on?" and we should be able to get back to you.

MS. FOREMAN: And I would like to echo what Alberto said. We've heard a couple stories. Obviously, we don't have all the facts here, but from what I've heard, some of the examples are not our typical processes, and they are certainly not our practices. So if you are having issues with communication, please raise it up to Alberto, raise it up to me, because if you keep it down at the reviewer level or at the branch chief level and we don't hear about it, we can't fix it. We have to know it's broken to fix it.

MR. LEAHEY: Mark Leahey, with Medical Device Manufacturers Association. First, let me thank you all for your willingness to engage here today, and also many times in Washington. I think, obviously, the uncertainty and the fear, I think, is something that obviously is driving a large part of this attendance, and a lot of that is driven by, you know, the politics in Washington and some of the pressures you are under.

I was wondering if you could talk a little bit about unique device identifiers and how that may play into the review of medical devices moving forward. Because I think, what we are seeing now, at least from our members and the VCs we work with, it seems to be the process is front-loading more of the -- trying to really minimize all risk out of the process on the front end versus having a reasonable amount, that risk-benefit profile, and then, in certain instances, having reasonable post-market surveillance in place to make sure that additional data is coming -- generated. And while registry is maybe cost-prohibitive or unwieldy, how do you see UDI playing into this, moving forward, to help perhaps alleviate in the front-loading of the requirements, to allow these technologies to get on the market and allow patients to have access to them?

DR. SHUREN: Sure. So, if we're ever going to be able to take advantage of information that's generated every single day in clinical practice, and to use that to inform decision-making, then we need to be able to link the use of that device with the patient experience. And the unique device identifier is critical for making that happen. So, you know, on the drug side, you've got a national drug code, something that will tell you, "Here's the manufacturer, here's the drug, here's the dosage." And that will come along, you can have it in the record, you know what you are dealing with. In devices, we don't have anything like that yet. So, in the electronic health record, someone may write in the name of the device, and if there isn't enough specificity, you can't find that. It's also text, so linking that up with the rest of the information is very hard to do. The UDI would essentially say, "This is the manufacturer, this is the device," and may provide even more specifics. You might be able to drill down to which particular device, you know, was it from a particular lot or time period. Congress actually put a provision in the Food and Drug Administration Amendments Act from 2007 to set this up. We happen to think it's critical if we're going to be able to use experience -- real-world experience -- and we would like to do that. And if we can get some rigor, then, in what's collected, recognizing there are biases that may be in there, but we might be able to then use that for supplementing what we do on the pre-market side. That may influence what our data needs truly are rolling in the door. It would also allow us, if we sort of said, "You know what, here's where we are on risk, and if we think you're there, it would really be helpful if we could actually have a better understanding of this device once it goes on the market. This will give us a better ability to do that. So I think this is critical if we're are going to get that stage where what happens afterwards with the device could help sort of affect what our data needs would be in making a pre-market review decision. Not only that, if we have a better understanding what's going on with a device, we are going to be less likely, subsequently -- you can think on the one side, well, more information, does that mean you are going to ask more questions? Well, you know what, on the other hand, if we have a better understanding of a technology, that's where we actually wind up asking for less information. That's where we tend to be more consistent in what our expectations are for a technology. So capturing that real-world experience is not just useful for you to think about what the next change should be; it's actually helpful to us in determining what our regulatory expectation should be. So we consider developing a UDI a top priority for the Center. We are moving forward to issue a regulation. We have to go through rule making. Our goal is to get that regulation out. It will be proposed, there will be opportunity for comment. We've had several pilots going on, some with companies who are actually here in the room, to sort of help us figure out what that system should look like because now it's not just putting out the number, we actually then have to collect that information and make that available for other people to use -- not the real-world experience, but the UDI, so people know what it is. And then that will also help us to link information that we have at FDA together.

So one of the other challenges -- and I will ramble for a short more minute -- on consistency, is do we have access to all the information that is actually in our possession? Do we actually have put together information in a useful way for our reviewers? Because one of the challenges is, we make past decisions. We get new information about what happens to a device on the market, and if we can't connect the dots and pull it together, and do it in a timely and useful manner, then our reviewers have insufficient information and they are also more likely to come to inconsistent decisions.

So another part of what we are doing is, on the side of knowledge management, that we actually do a better job ourselves of identifying what's the basis for our decision, making that information more readily available, not only for you, but for us, and better linking information that's collecting subsequently. So what you actually have is a risk-benefit profile for a product that you can update from time to time with new information. That's the packet of knowledge that we need to have. That can have a profound impact on our pre-market review. It can have a profound impact on our ability to make better informed and consistent decisions. And UDI is just one piece of that puzzle.

MR. YEAGER: John Yeager from Assista Medical Systems here in Eden Prairie.

First of all, a comment and then a question. The comment regarding the escalation beyond the reviewer, beyond the reviewing staff and/or the division is something that the industry takes very seriously because of the concerns over the relationship with the reviewer and the reviewing division. And it is something that we hope that the senior leadership within CDRH recognizes that we avoid that, if we can, in trying to resolve things at lower levels.

So the question goes back to guidance documents. I think we've heard several times today where people have questioned when are guidance documents being acted on by CDRH staff. And the question that I have is what is the policy from senior leadership at CDRH in terms of when a guidance document should be acted on by CDRH staff?

DR. SHUREN: And just a quick clarification. Acted on in terms of there's existing guidance to use or to actually go forward to develop?

MR. YEAGER: We believe that guidance documents are acted on way before they're even published to the industry, and in a draft state as well, before there's comment, before there's finalization. And as a result of that, we get caught blind-sided and without the ability to respond because again the transparency of the communication doesn't allow or doesn't get us there. And so the question is, is that your policy? Or is it intended to be finalized before it's acted on by your staff, and if so, what are you folks doing to make sure that that's the way it gets dealt with?

DR. SHUREN: So this goes back to the question about when there is new science, and if we make a decision to change our expectations, whatever those are, and I'm prefacing for the moment, assuming we made the right decision to change expectations, one mechanism for communicating it is the guidance document, and what do you do before that guidance is out? Here is what the Center faces. When you have information and you understand that expectations need to change, and products are coming before you, do you say, I know this to be the case, we need to look at something else, there's an issue here we're aware of and ignore it because we don't have a guidance out yet, or do you act on it? I mean, you can think about it this way as a physician. I am now aware of other concerns with a patient that has this kind of disease. I could look into it further, or I would put aside that information. You would never do that in practice. That's what we're confronted with as a Center. Because the information we get, we see things -- not just for your device -- we see it for your competitors. We get information from other countries and we need to act on it. But what you're stuck with, on the down side -- and this is a problem -- is if we change our expectations -- and I'm going to make the assumption it's a well-founded -- there's another issue about making the right decisions. But we have made that decision, then we have to find the way to communicate that to people more quickly than guidance because guidance is not an effective tool for getting the word out. It's effective for providing greater information and an opportunity for vetting, but it is not a good tool for telling you our thinking has changed. And that's the piece with new science that we are trying to work out. And part of it is this issue with legality, as to what we can say with more detail that starts bleeding over and turns into guidance, we have a guidance process to look to. And I will tell it is a conversation that I have been having with our chief counsel, that we got to figure out a better way to do it because we can't leave people in the lurch, that if expectations have changed, that they find out about it on an ad hoc basis when they're rolling in the door. That's not good for anybody.

MS. FOREMAN: And to follow up on that, obviously, we have many more specific device types than we have device-specific guidance. So, in most cases, our review practice is not based in guidance because we don't have the guidance out there. So what we're looking at, as part of the transparency initiative that was mentioned, for 180-day supplements -- we cheated off OIVD because they have such a nice turbo 510(k) program, we are trying to model it somewhat -- we are posting our review memos for 180-day supplements. That's a way for us to communicate, "This is the supplement we got in today. These are the questions that we asked." So that you can see our review practice, and at the time, you know, well, this was what was needed at that time to ask -- that we asked the sponsor to support approving a product. So that way you can see almost real time our current data requests. Hopefully, that will help eliminate the time lag between publication of guidances when we can publish device-specific guidances. Obviously, there are areas where we just can't get to all those product areas.

MR. SILVERMAN: Let me also talk about guidances in the compliance context. I think it's worth just noting what in some respects is an obvious characteristic. These are guidance documents. They are not mandatory. In the compliance context, they reflect the Agency's thinking around a particular issue. It would be inappropriate for compliance staff within the Center to treat guidance documents as obligatory for regulated firms, and regulated firms shouldn't regard in that respect either. Regulated firms have a responsibility to show that they are in compliance with the regulations and the laws that we administer, not the guidance documents. And we are very open to the idea that firms can independently demonstrate compliance, even if that compliance is demonstrated through a pathway that's distinct than the one described in a guidance document.

MS. FRESTEDT: All right, I will follow up on that. You've been talking about how we pull together a lot of information and share it with the community, and I wanted to just follow up on a drug device kind of example. So I applaud the issue of trying to be more transparent and doing things like sharing the supplements on the website and doing the total life product life cycle. I thought that was interesting, and I didn't realize it was a part of the initiative, but I did uncover it as I was looking, so that's great work. But as you have a vast amount of information that we in the industry don't know -- and forgive me, Joy Frestedt, Frestedt Inc. I'm a consultant in town. You have a body of data that is across many different devices and many different drugs for the other side of the business. You develop information around that you might be able to share with us, and I would like to explore that concept of it's not a rule making, it's not a guidance, but these things that you can share, like the supplements, like the product management. I think this is an important area for us to continue discussion and debate because what we're facing in the industry right now is an increased scrutiny in every area, at least that's what it feels like to me, much more in the last 6 years than the 15 before that. And for the drug device combination, the example I would like to use is you've got a drug maker that has a product that's going into a device where the Agency is requiring compatibility data at a very deep level, which is new territory for us. And I am wondering how you share that body of knowledge that drives that decision-making about how the drug is interacting with the device for a drug-only company driving that partnership? How can we better talk about how industry -- separate entities may talk together better -- and also how the device and drug inside the FDA can talk together better about how to do that compatibility piece. Did that make sense? So more about what we can do -- except rule making and except guidance -- what are some other initiatives we can develop and grow?

MS. FOREMAN: So you're touching upon combination products, and I would say right now that's probably one of our most difficult areas to manage, in terms of you have to traverse two Centers, typically, sometimes it's two separate applications, sometimes it may be one application, and you may or may not have a concerted effort from manufacturers to partner together, or you may just have a manufacturer who says, "I want to label my product to be used with X, Y, or Z," and X, Y, or Z is like, "Well, I don't really want you to be used with my product." So, in terms of trying to answer this in a general sense, because each different scenario has complexities unto its own, I would say we are trying to improve our combination product experience. We are trying to be more transparent. We have problems even with our -- just the designation of combination products and who is the lead Center, because the process for which that is done through the RFD -- Request for Designation process -- is not a transparent process. And we can respond to a specific manufacturer, "We're using the primary mode of action algorithm." When we use that PMOA algorithm, we're looking at something that we may have regulated as a device for years, and now we have a firm who submitted an RFD, and we now look it, and we say all of a sudden, "Well, you know what, we actually think the mode might be more of a drug-like mode." So now we tell one firm that "You are now a drug." Now, we have this entire industry that has 22 510(k)'s that has the exact same mode of action, how do we reconcile that, because that RFD is confidential, now we need to figure out a way to share this information to these other firms who are frankly not going to be happy that you came and asked the question of the PMOA because they were quite happy being a 510(k) as opposed to being an NDA. So we are currently under discussions with chief counsel on how to share that type of information.

Now, going to the issue of how do drug companies and device companies share information, you know, we can make certain information available, but I think, to the extent possible, the drug companies and the device companies themselves are going to have to find a way to work together as well, to share that information in a common way. We have just recently published the GMP rule, where -- or the guidance where we basically said, "You know what, we want you to pick whichever way you want, whether you want to be subject to device GMPs or drug GMPs; whatever you are designated as, do the add-ons." So that we are trying to make the language somewhat universal. So, for example, if you are a drug lead combination product, you are going to meet the drug GMPs, but you are going to have to add purchasing controls. You are going to have to add design controls so that it is regulated in a consistent way across both Centers. We are trying not to disrupt the communication process because we know if you're a drug company, you're used to drug terminology, but we do have certain provisions that we'd like to apply across both products. But in terms of communicating, we're working on it.

MS. FRESTEDT: And we definitely feel your pain, right, so we've got drug and device companies that need to talk together, we've got the device and drug side of the Agency. So the more that we can talk, and the more that we can help each other create avenues for sharing that information, the better off everybody is going to be. But I will go back to what people said earlier about making sure the focus is about a real risk, right? So a lot of what we're seeing -- and I will echo what people have said -- is you've got new people in the Agency, not a lot of experience, some people wanting just information for information's sake, a lot of science-driven people like myself. But somehow we have to keep talking together and actually maybe create some workshops for us to think about where can we create clearinghouses or some way to do knowledge management and create a better model because what we've got right now is not working, and it is causing a lot of companies to go out of business. And, as a consultant, I want more business. And as a patient, I want better care.

So, thank you. I appreciate it is painful.

MS. FOREMAN: I couldn't agree more that we need to open up communication.

MR. GORDON: Thank you. Mark Gordon with Boston Scientific.

I want to thank FDA for this forum and the opportunity to share our thoughts. I think this morning the speaker shared some very important messages regarding predictability, transparency, uniformity, industry engagement, and the value of innovation. I think what we've heard now is some very specific product cases that really show a light in terms of the challenges we are experiencing. So what I thought I would do is have just a very brief comment on sort of that middle part, and the middle part is the strategic priorities document that the FDA released.

First, I want to compliment FDA on that document. It's very granular; in terms of transparency it's a huge step forward, in terms of over to two to three years, understanding where the Agency is and where we want to go. And I just wanted to provide a few suggestions in terms of how the Agency might be able to utilize that document in an effective manner.

First, for specific work streams, you might want to consider identifying those that industry could engage in. There are some that really are not so relevant to us, and there are some that are directly relevant to us. You might want to flag those, and say "Those are specific issues that we intend to reach out to industry for." Examples that you've already done include 510(k), regulatory science, transparency, and I'm sure there are others. I think the ones that flagged my attention were signal escalation, globalization, risk communication, and establishment of five most important public health needs. I'm sure there are others, and I'm sure others would have comments on that, but there seems to be an opportunity there.

Second, perhaps you could identify those milestones that would have public visibility. So you are going to complete a certain action or certain work stream. And some may be internal and they don't need disclosure; others may. So you may want to consider flagging those, and say, "Once we're done, we're going to let you guys know."

And my last suggestion -- and then I am absolutely interested in your thoughts about these -- would be some sort of update, perhaps a quarterly update of not only this is what you plan to do, but this is what you have accomplished, these are the changes to the plan, and perhaps some have been deleted, some have been added. Maybe that's a quarterly, perhaps an annual update.

Thank you.

DR. SHUREN: Along the lines -- it's a great point about the priorities we have in place, and yes, we are looking to provide more updates in terms of what we are accomplishing and where we are in the process because we do, once we make those commitments, you're going to want to know did we live up to them or not and move things forward.

I think the issue about engaging, this is a big one. And I won't say it's tension; it's figuring out the right way to do it. How do we have the better engagement with industry? So, first off, we are all in a long-term relationship. And that's what it is. It is a relationship; it is long term. We have to be able to talk to one another. We have to be able to disagree with one another, and we have to be able to respect one another for it, but we have to keep the lines of communication open. And if people are feeling, "We can't come in, we can't talk," we can't have that. If people feel, "I don't want to come in and talk, I'm worried about what the perspective would be," I would say, "Come in and talk." It is the only way, as Christy said, we are not going to be able to know how to address issues if we are not aware of it. And don't simply assume because something occurred, you know, down at one level in the Center, that that's actually going to rise up and catch attention further up the chain necessarily. In terms of different ways to do it, we have to think about the right forums because we don't want to waste anyone's time. And this kind of a communication, face-to-face, all together, I find helpful. It would be pretty challenging, though, if we were out here on a routine basis, and this is just in Minneapolis. I can't tell you how many other places have been calling, "So, when do you plan on coming out to our neck of the woods?" At the same token, I doubt that you all have budgets to be flying into the Washington, D.C. area all the time, either. So we need to sort of pick and choose our right forums and how to get the most out of it. There are other avenues available.

First of all, folks who do want to meet with us, if there are issues to talk about, we meet with people. I think -- I would hope there are people sitting here today who have been in the door to talk to us, and we try as best as we can to be accommodating, particularly on the bigger picture issues. When it's a product-specific under pre-market review, we have pathways that are in place, and they are there for a reason. If they are not the right ones, we need to fix them, but we follow those processes, we try to. When it is some of these broader issues, the doors are somewhat open for what you can do and communicate with us. If you have ideas on how best to do it, you should let us know. It is the only way we are going to know what is of interest to you, what will work for you.

For guidance documents, you can draft a guidance document. I will tell you there are some groups who have done that. My suggestion is do your homework beforehand. Simply sending us paper or broad thoughts is not all that helpful. But if you actually write it, I mean truly write a guidance, have it thought through and explain why, that can make a big difference. And sometimes we get things, they are very informative. We are going to be more likely to follow up on a guidance where you have already taken us very far down the road. Now, it still -- it's an agency -- the Agency ultimately puts out the guidance, so yes, we have to make the decision to adopt something or not adopt something, to make changes, but it really helps a lot if you put pen to paper and flesh it out. And over time we have actually gotten some very thoughtful proposals, and yes, it does influence our thinking, more likely to get out the door, so that is available to you.

Here's the challenge we face in having conversations when we do this: Can we work on things together? For example, guidance. If I do something like that, that is public. To come in the door and have a private conversation to work on those things, I can't do that. That has to be in a public setting. And that is one of the challenges people face. "Well, I don't want to do it in that setting, I want to come in and talk." The other is our ability to actually work through ideas. We can kick some ideas around, but to really go through, in some cases, on making changes, we can hear things, we can answer questions. The minute we start getting into, "Yes, here's where our decision-making may go," I no longer can keep that closed. So, as a government official, when I start having those conversations -- just like here, if we locked the door and I talked about something, it doesn't matter the doors are locked, that is now public information, and I have an obligation in terms of allowing other people in on that conversation. That doesn't apply to you. It does apply to me. And that's why I said that is one of the tensions in the kinds of dialogues we can have. Have a free, open, and back and forth and kick it around would actually be good. It's staying within those boundaries. But figuring out how to do that, the best extent we can, in a way that's useful to all of us, we would be very open to hear ideas for how to do it.

MR. SILVERMAN: I would like to just follow up and talk about one facet of the communication issue.

I agree with Jeff's point that we are all involved in a long-term relationship, and that in the context of that relationship, communication is critical. Communication is a two-way street. And so I look at communication in some respect from my compliance perspective. And I will tell you that there have been situations in which, in the course of conducting our compliance activities, we have tried to communicate with the firms that we have regulated, and we have found resistance, silence, lip service in terms of responses to the questions that we're asking. It is extremely frustrating. Now, we are nothing if not tenacious. We are not going anywhere, so ultimately we get the information that we need to make a compliance decision. But I will tell you, in all candor, it affects the credibility of the firm with which we are dealing. And it affects our openness to the firm in the specific context in which we are dealing with them in later contexts when they try to explain to us that our perceptions about what we believe to be a problem are misguided. So I just want to take this opportunity to encourage open communication, even in those situations where it may not be immediately and obviously in the company's best interests. If there is a problem, or we believe that there's a problem, we need to know about it. And the only way that we can make an informed decision is if we get prompt, comprehensive, accurate information from the firms that we are dealing with.

MR. EMERSON: Marty Emerson, Galil Medical, two quick ones.

Maybe you could comment, share your views on physician-industry collaboration and the relevance to all the things you are wrestling with in terms of the regulatory processes. And then, secondly, do you see a more formal and expanded role for physician specialty groups in a lot of the expertise that you are trying to get your hands around?

DR. SHUREN: First off, in terms of relationships -- collaborations between industry and the health-care professional community -- we are very supportive of it on a couple of different levels. They are the users; you need to talk to them. In fact, in some respects, I would say you need to probably talk to them more. There was just a report out from Robert Woods Johnson on behalf of AAN kind of looking at -- they did several of these two-day drill down sessions regarding nurses' perceptions on technology. And one of their feedback was, "You know what, people are not -- in the device industry -- aren't necessarily listening to us or asking us for the input." I strongly encourage those conversations. And, of course, then, the second is even in the development, of course we'd like to see that, where people raise questions, and you'll see it on two levels, it comes down to these conflict of interests. So, on the one hand, we have it for our panels. Partly, we are where we are -- I hate to say this -- we try to bring in experts and have a pool of experts from which we can draw. For a particular panel, we do have statutory limitations on what we can do for a panel, from conflict of interests. And those rules got tighter in the past few years. They didn't loosen up, they actually got tighter in terms of our ability to have a waiver for particular experts to participate on the panel. That creates challenges for the Center, but we have to comply with them. We try to do the best we can. What we are thinking about doing, though, is how can we leverage that expertise before we ever get to panel or in other circumstances? And one of the things in the strategic priorities is a discussion about creating this, if you will, network of experts, people we can tap into. And they would come in two flavors. If we had a deal with confidential information, I need that person cleared for conflicts, I have to do that. I am required to do it, and they need to be what we call a special government employee, I can do more routinely, or I would have an agreement on sort of a case-by-case basis for a particular scenario. And that is more challenging to do as one-offs because you have to have an agreement in place, and they have to be bound by protections of confidentiality. There are lots of questions I can ask that do not require confidential information that I can reach out to experts. So part of this effort with innovation is about developing that kind of a network so we can reach out to experts on a more routine basis, outside of the Center, to ask for input. Conflicts, if they have a relationship with a company, it's something you take into consideration in terms of what you may do with that information, but that doesn't mean you discount the feedback. You got to weigh it together. To make it happen, though, the other thing I need, I also need the experts to talk to the experts. Because if you are going to have a conversation with an expert, and you are going to decide, "Will I rely on this information?" -- because experts disagree, you got to sift through -- I need my own experts. They may not be the cutting-edge person on this technology. They will talk to that person. But I can't have the dermatologist -- no insult to dermatologists -- having the in-depth discussion with the cardiologist. The cardiologist needs to talk to a cardiologist. Engineers with particular expertise, they need to talk to one another because they will understand what they are talking about. So that's the other side of the equation that we need to address. We need to have the experts who talk to the experts, and we need -- outside the Agency -- and we need to set up so that we can tap into the experts outside of the Agency when we need to, to have better informed decisions. And that is one of our priorities on the table.

DR. GUTIERREZ: I wanted to add -- and I actually think that we have been innovative in ways to do that. I mean, I think if you look at the last year or so, you will see that the Agency has engaged in particular issues that we see, for example, glucose meters, we engaged the community in problems that we saw. We asked for experts to come and speak. And so we are being proactive when we see issues. We are trying to engage the communities that have the expertise and to help us look and move forward in areas that we see issues.

QUESTION: Dr. Shuren, Christy, Dr. Gutierrez, Steven -- thanks a lot for coming.

I want to first start out by saying we should all thank Heather Howell for this nightmare of putting this thing together, and she did a tremendous job. If she's here, could she stand up, and I think we should applaud her. If she's not here, let's still applaud her; maybe she'll hear it.


I think after -- I want to dovetail on Mark Leahey's comments from the Medical Device Manufacturers Association about front-end loading requirements. I think we all agree, predictability, consistency, and then reasonableness. And if we have predictability and consistency, but the data requirements ultimately are unreasonable, we really haven't moved the ball much here because we really can put a lot of -- at least the 510(k) venture capital-based business and some of the PMA business out of business. So I think a lot of this devolves down into sort of a viewpoint of how we can -- inappropriately maybe -- front-end load requirements, like on a 510(k), and I will give you an example: the new infusion guidance.

First of all, let me say this one thing, Dr. Shuren, and I have said this to you privately: We admire you because we have never had a Center Director who's been out meeting with the public like you have and who has put into place so many initiatives that are trying to improve our industry, and we do appreciate that.

So you look at the infusion-pump guidance. One of the concerns we would have as an industry is there's a lot of good things in there, and you should want to consider a lot of what you're doing, but be mindful that, as you are looking at a REMS-like solution that would be very appropriate in the drug industry, when you import that into a device context, that can add a lot of front-end requirements -- by the way, aren't in the statute -- and would require a lot of front-end loading on risk analysis. I think this all ultimately devolves into risk analysis, and I want to give you an analogy to help you think about that. Think of my kids. They are the most precious thing I have. They are now 26, 25, and 18. Other than the 18-year-old, I have pretty much gone through the gauntlet with them, right? But if I look at my kids as a medical device, and you look at the design history file, they've got their mother -- it's a multiple predicate situation, by the way. They've got their mother, who's a pretty darn good predicate, and then they've got me, and we're trying to combine those two to produce those kids. When I -- as they are growing up -- when I --

DR. SHUREN: Do you want to know if we would NSE or SE the product?

QUESTION: I deserve and resemble that comment. But when you look -- when I look at my kids, I had to look at a lot of things, at the inputs, as we are going through life. And you release them to the world, ultimately, to a world that is unknown. They'll have friends that I won't like, and I'll eventually have to modify behavior as I learn things as I go along. I will just have to change -- I might have to take away the car from time to time because they are using it inappropriately. There's so many risks that they encounter. And do I love them? And do I want to control their every single behavior as they go through life? Yes. Can I do that? No. And, similarly, I think I want to apply that analogy to you guys. You are doing such a great job and do care so passionately about what gets out there, we recognize that. But remember you can't possibly cover all the risks. There will be risks in medical device, and we need to allow them to occur because that's the only way we will benefit society through the iterative process. So I encourage you -- you know, it's -- I think sometimes ideologically, you see reviewers who can't quite let go. I'm worried about the third-party review program as an example of not being willing to let go. That's a very valuable program for this industry. So I encourage you to just think about that. That's one of the reasons I saw -- I know MMDA, our group, actually listed least burdensome, had a least burdensome champion on every team. I think you used to do that, used to train very well in least burdensome. You have four great guidance documents that have sort of fallen into disuse. Have somebody on that team that's just a check mark. Somebody who says, "Can I challenge you internally?" and nobody rolls their eyes at them within the team, that they have a legitimate and responsible right and authority to do that.

So that's my comment. We do very much appreciate all that you have provided today.

DR. GUTIERREZ: I would like to -- well, having someone at least burdensome in every team I think is going to be -- I am not sure we have that many reviewers. But I would like to address that point in terms of my reviewers, for the most part, are the ones that keep our feet to the fire when new requirements come. They actually think about industry more than you actually believe. I have a lot of reviewers that will challenge us. When we are thinking of new initiatives, they are the first ones that come and say to me, "What is this? Why are we putting these new requirements on industry?" We have lots of those people, we don't just have -- we have both. We have people who are on the conservative side. We have people who actually look after industry, who have worked in industry, who actually understand industry. At least in my office, if you look around, we have people who came from industry, we have people that came from academia. And we tend to try to keep a mix because we actually do believe that it is very good to have that input of somebody who can challenge and say, "Is this the right thing to do?"

MR. SILVERMAN: So I'm a huge fan of metaphors, and then I usually try to build on them and then crash and burn catastrophically. So we'll see if I can put that to the test. Your point is well taken, but let me respond by a similar metaphor. I have two daughters, same father, same mother. As any parent of multiple siblings know, they can come from the same parents, have the same genetic code, same environment. To suggest that they are the same individuals is an exercise in the insane. If my oldest daughter is responsible for providing medical care to patients, and if she provides that medical care in an environment where she doesn't do it appropriately -- patients can die -- and I'm out there saying to a regulator, "Well, my youngest daughter comes from the same set of parents, same environment, same et cetera, et cetera, therefore she should be able to perform the same function, with minimal prerequisite conditions. I don't think that that's necessarily in all cases a valid argument. And I think it is legitimate for the regulator to say, well, wait a minute. We need to acknowledge (a) as you say, we can't mitigate all risks, and (b) there are a lot of similarities, but because this is an individual, or in our world, a device that has the potential to either save or kill people, it's appropriate for us to ask questions to make sure whether or not my younger daughter really will operate in the medical marketplace in the same way as my older daughter. And I think, in our world, it is legitimate and appropriate in the best interest of patient care, and in the best interest of the industry that we regulate, to ask similar questions so that we make sure that patients have access to innovative products that can enhance their health care, but we don't proceed in a way that's cavalier and that puts patients at risk.

QUESTION: Well, I was told if I were to have children, they would go through the PMA process, so I said it wasn't worth it, although I am considering potentially fathering in Europe, so I will --

QUESTION: You don't think we could de novo those kids?

QUESTION: I notice that scared everyone off from coming to the microphone.

MR. VALENTY: I will add a point here, and I'm a father of six kids. But risk, we talked about that a little bit ago, the patient should be -- and I hate that word, it should be end user or consumer because that's what I am, I'm an end user of these products. And the patient should be involved with a decision in the risk to -- any procedure is a risk, and you cannot -- it's never 100 percent. We are all involved in that decision. So keep that in mind, that's nothing perfect when you introduce it to the market.

DR. SHUREN: Oh, actually it's good timing. We ran about 10 minutes over.

First, let me thank all of you for coming out today. We really appreciate the very strong showing and the very lively, and what we found -- I think I am speaking on behalf of everyone else here -- very helpful dialogue, and we would like to continue it.

Let me say, too, that we are, as you are hearing, we have family, and we have friends, and they, too, can rely on medical devices for their healthcare. We have a strong interest in the medical device industry. We have a strong interest in their being successful. We have a strong interest in good healthcare for patients, so we are part of that team. We are not here as the people hiding in Washington who are really just trying to make bureaucratic decisions. We are trying to make the right decisions because ultimately it is in all of our interests because, again, we are people and we have family and friends, and for many of us, we are also healthcare practitioners. We have had our own patients, and we have been through our own life experiences.

So, with that, let me thank you again, and enjoy the rest of the day.

(Whereupon, at 12:10 p.m., the meeting was concluded.)


This is to certify that the attached proceedings in the matter of:


May 18, 2010

Bloomington, Minnesota

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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