Training and Continuing Education

GUDID Account Set-up - Transcript


Moderator: Heather Howell
January 30, 2014
1:21 pm CT

Coordinator: Welcome and thank you for standing by. At this time all participants will be on a listen-only mode until the question and answer session of today's conference. At that time to ask a question please press Star 1 on your touch-tone phone and record your name at the prompt.

This conference is being recorded. If you have any objections, please disconnect at this time. And I would now like to turn the call over to Ms. Indira Konduri. You may begin.

Heather Howell: Hello and welcome to today's FDA Webinar. I'm Heather Howell, the Deputy Director of the Office of Communication and Education in FDA's Center for Devices and Radiological Health. Thank you for joining us.

Today the Center's GUDID expert, Indira Konduri will provide information to help clarify FDA's draft guidance document Global Unique Device Identification Database, GUDID which is intended to instruct labelers of medical devices what and how to submit data to the GUDID database.

Today's Webinar, however, will focus specifically on how to set up a GUDID account. This is important for manufacturers of Class 3 medical devices who are required to comply with the UDI requirements by September 24th of this year.

I would like to remind all of our listeners that overviews of both UDI and GUDID are available on the CDRH Learn section of our Web site. In addition, today's presentation and a downloadable version of the slides will also be available on CDRH Learn.

Following the presentation your presenter Ms. Indira Konduri of CDRH's Office of Surveillance and Biometrics will welcome your questions and we will do our best to provide answers.

We ask that you focus your questions on specific the GUDID database today. If for some reason we cannot answer your question contact information will be provided within the slide presentation.

We strongly encourage your questions and feedback about this very important program. I now give you Miss Indira Konduri.

Indira Konduri: Good afternoon everybody. It's a great pleasure to be here to present on GUDID. And thank you Heather for that excellent introduction.

I have a lot to cover today. And as Heather mentioned the focus of today's topic is the GUDID account.

We did do an overview presentation back in December. And as Heather mentioned the slides are available on CDRH Learn Web site.

We hope that you've taken the time to go through it or are at least familiar with the draft GUDID Guidance document. That will be greatly helpful as we get into the deep dive of the GUDID accounts today.

I will briefly cover overview at a very high level and jump into accounts. Again, this is important for all GUDID submitters specifically targeting today's presentation, the Class 3 labelers and labelers of devices like some centers the PHS Act because those submissions are due by September of this year.

So we'll talk about the accounts then go to how to request a GUDID account and how do you get started with the GUDID submission at a high level. And then we'll talk about how you can contact us.

So there's a lot to cover. So get your seatbelts on and we'll start.

All right, so the authority for Unique Device Identification System was provided to us through the FDA Amendment Act of 2007 and the Safety and Innovation Act of 2012.

The proposed rule came out in the - on the 10th, in July 10 of 2012. The final rule was released last year on September 24. And you can get both of those our Web site.

And the next slide here is just going to show you the compliance dates. And as I just mentioned Class 3 devices and devices under the PHS Act are required to submit the GUDID by September 24 of this year. And you can just view the rest of the slide at your leisure.

So with regards to overview at a very high level UDI stands for Unique Device Identifier. It's composed of two pieces, the device identifier portion and production identifier.

The DI is the mandatory or the fixed version of the UDI. It identifies a specific version or model of the device.

And the Production Identifier or the PI is the variable portion. This is the portion that changes and frequently identifies a lot or batch number, serial number, expiration date, manufacturing date all for HTTP devices, the human, cellular and tissue-based products that are regulated as devices that is a distinct identification code.

So together this DI and the PI is what makes up a UDI.

So the GUDID -- you'll hear us talk about GUDID lot -- GUDID stands for Global Unique Device Identification Database. The GUDID is going to serve as the master repository of device identification information.

Now in the GUDID we are only going to be collecting the static portion, the non-changing portion, the DI, the Device Identifier. Now remember this is the static portion that is for a given version or model of the device and PI is not submitted to the GUDID or stored in the GUDID.

However, we do collect information from you, sort of yes or no flags where you tell us what PI attributes are on a label, are out on your device label.

So we'll ask you does your label have lot or batch number and you'll answer yes or no. So that's the PI information we collect. So GUDID does not collect the specific PIs for every widget that's out there.

So here is an example of a DI record. You'll hear us talk about the DI record in the GUDID world a lot.

So DI stands for again Device Identifier, the static portion. So a DI record in GUDID is basically the device identifier for a given portion of the model of a device and the GUDID attribute.

The majority of the GUDID attributes are data (traced) either on the label of the device or on the labeling of the device.

So if you look here on the bottom left-hand corner I just want to draw your attention, label or name and physical address is listed. Keep that in mind. We'll come back to it during the presentation.

And if you look on the top left-hand side, there is brand name. This - so this is a fictitious medical device label that's on our Web site. And we've just mapped it to the attributes in GUDID.

So for every version or model of the device out there if the UDI rule applies to you, your device then will have a DI record in the GUDID.

So moving right along here now we talked about the GUDID overview. So this picture just gives you a high level overview of how GUDID is set up.

If you look on the blue box in the top, that tells you the submission options that are available. You can submit as a labeler of GUDID, I'm sorry, as a labeler of medical device. You can submit the GUDID either as an XML file or by logging into a Web interface.

On the right-hand side the pink box shows you how to pull information out of GUDID. And you can pull information out by accessing the Web interface or there are some system-to-system search and retrieval options that are available also.

So just I'll take a very few minutes to talk briefly about each of these starting with the GUDID Web interface.

So the GUDID Web interface is a secure Web application. Submitters of device information will be provided with logins, username and password.

You come in, you login and you can enter the DI record that we briefly talked about one record at a time. And you can put that in.

And public users can also use the GUDID Web interface to search and pull information out of the GUDID. And they would only provide information, the published attributes.

So now on everything that's entered by labelers will be released to the public so published attributes can be accessed by the public via the GUDID Web interface.

So the next option we have for labelers to submit is the submitting to us as an XML file.

So Health Level 7 for those of you who don't know is a standards development organization. And they work in the healthcare arena to develop messaging standards to enable standardized sending and receipt of healthcare information.

So the HL7 group has put together structured product labeling which is a labeling standard. And what we've done is to take this HL7 SPL standard and we've constrained it to the GUDID use case. And we've come up with a format so you can take a (self side) - or you can take your DI record, pull it into an XML file in compliance with the HL7 SPL standard.

And you can send it to us through the FDA electronic submissions gateway. It will come to CDRH and it will be loaded to GUDID.

So if you wonder how to put that into an XML format we've come up with technical specs that's available on our Web site.

Once you have that and you review that information you should be able to take your DI record and generate the XML file.

And the FDA electronic submissions gateway is a way for FDA to receive electronic regulatory submission in a secure fashion.

The gateway authenticates the sender so they know who it's coming from and the gateway also makes sure that the information comes to CDRH securely.

So you have to use the electronic submissions gateway to send it to us. And we'd ask that there is - you conduct testing before you submit to production GUDID just to make sure your XML is formatted correctly and all the exchanges that have to happen along the way happen as they should. And we'll talk a little more about that later in the presentation.

So onto the pink box on the right if you remember that earlier slide, GUDID search and retrieval. We basically have as I mentioned system to system research and retrieval and also the Web interface.

The Web interface is where the public consumers or healthcare providers and labelers, anybody can come and search for device information.

There is a quick search feature focused on four attributes listed on the slide. And then there is an advanced search feature where we have exposed additional attributes for your searching.

The system-to-system search and retrieval we have a Web services capability -- extremely basic. It just accepts a DI number. This is again device identifier number for your device.

And if that's in our database they return back to you on the published attributes for that record.

Database download capability we're presently working on requirements for that. And we hope to make that available sometime this year.

But the key thing to find out here though is all of these, both the Web interface search and retrieval, and the system-to-system search and retrieval, everything is disabled at this time and mainly because we have no records to search in the database.

Once we have a few records we would love to open this up. So we're looking for those record submitters. So if you're out there please send us your submission.

All right, so that kind of wraps up my overview. Again, this is the focus of today's presentation is on the account so we won't spend too much more time on any of that.

And I encourage you, those of you who have not seen our overview there is a Webinar that we did back in December. Do take the time to review that. I think you'll find that helpful.

So now let's jump into the accounts. A lot of nitty-gritty coming your way so again, take a deep breath. Here we go.

So GUDID accounts, GUDID accounts is required for anyone who wants to submit the GUDID. And again, the main reason is we want to make sure we know who is putting information into GUDID.

As I mentioned this is a repository of device information. And we want to make sure that we know who's putting information in and that they are a FDA approved products.

So it identifies the labeler organization in GUDID. And to identify the labeler we're going to be using DUNS numbers. And we'll talk about DUNS numbers shortly.

And once you have an account you can enable to use a labeler to manage access to GUDID inside your organization.

So you can decide if you want to let Jane and Mary access GUDID for you and do submissions for you or if you want Jill and John to access GUDID. So, you have the ability to manage who has access inside your organization.

Now the GUDID account, you have to request it from the FDA. We the FDA will create the account for you. And we don't make the user information in GUDID public. So, only this revised information is released to the public.

So the fact that Mary and Jane are accessing GUDID and their email address and phone numbers will not be made public.

The GUDID account is again not required if all you want to do is pull information out. So if you are a public user and you want to search glucose meters, you don't need to have a GUDID account. You can come in. You can access the quick search and advanced search.

The only time you need an account is if you want to put information into GUDID.

So let's talk about DUNS numbers. DUNS stands for Data Universal Numbering System. It is assigned by Dun & Bradstreet. Many of you may be familiar with this from a financial reporting perspective. It's a nine digit number.

However, DUNS is now being used more and more FDA. And I believe DUNS was identified as the universal facility identifier recently for FDA.

In CDRH the Registration and Listing program has started accepting DUNS numbers voluntarily as of past December. So we in GUDID are also using DUNS.

And one of the main reasons we chose DUNS was to help us standardize company names. The variations of company names are numerous in many of the databases.

So the purpose here is that we would ask you to give us a DUNS number and you as the labeler manage how you want your name and address to appear.

So you manage your DUNS information. And all we do is we take the DUNS number and we pull the name and address from the DUNS database.

So we're not typing in Company, Inc., Company, LLC, company, you know, dot, dot, dot. You know, we're letting you enter how you want your company to appear. And all we do is put the DUNS number and they pull the labeler's name and address.

So it's important that you take the time to review your DUNS information and make sure that it is how it should - how would you would like it to help you in GUDID.

So in GUDID there are three different users for DUNS numbers. We are going to use organization DUNS number, labeler DUNS and third-party DUNS. And we'll go through this and what each of the DUNS numbers mean and how it's used in GUDID in a moment.

So now you're looking at a very, very busy picture. This is the GUDID account structure. And fear not. We'll go through this in detail from top to bottom.

I will jump around a little bit after presenting just a couple of times. I found that the top to bottom flow isn't optimal. So we may revise this picture in a later version of our guidance. But bear with me. I hope to pull it all together for you.

So we'll start from the top.

So the top here identifies the labeler organization, the GUDID account and regulatory contact. So let's take that piece.

So again we start with the account. As I mentioned it identifies the labeler, the submitter of device information. And it doesn't matter which submission option you choose, whether you choose the Web interface option or the HL7 SPL option. You need a GUDID account. So, you have to get one.

Now in labeler - as a labeler organization, you can have as many GUDID accounts as you like. You can have just one. You could have many. The structure is very flexible.

So if you are a very large organization, you can break up your submission however it works for you.

You know, you could break it up by product area. You could break it up by geographical location. Or you can say I want to put it all together and everything is going to be in one single account. So the account structure has - it's flexible enough to allow you to do that.

And what you need is you need to give us an organization DUNS number. So we talked about DUNS numbers.

So the purpose of the organization DUNS number is just to identify your GUDID account. So it can be a headquarters number or a PIN and DUNS number. It's how you want your organization to be identified in GUDID.

And again, this is not released to the public because this is account information, not device identifier information.

Now for those of you who are database people, organization DUNS number will serve as a primary key. So once you use it for one GUDID account, you cannot reuse it for another GUDID account. So that's important. So you can only use it once.

But you can use it as a labeler DUNS number. And we'll talk about what that is. So just hold that thought for second.

The regulatory contact, these are people who are responsible for GUDID submission requirements. So every account must have regulatory contact.

They don't have a functional role in GUDID. They won't have a user login or password. So they're truly your reg people.

And we the FDA would call them if we run into compliance issues or any regulatory issue. That's the person we would contact. So every account must identify a regulatory contact.

Okay so far so good. So here is a screenshot I'm showing you from GUDID. And we have an organization detail for company Safeway Inc. And you see the organization DUNS number.

As I mentioned if you look on the top left-hand corner here we type in the organization DUNS number, the name then address and gets pulled from the DUNS database. So we're not actually inputting.

So when you submit this organization DUNS number, take a moment to see how you want your name to appear and make sure it is standardized and it's correct.

And the regulatory contact you can see right underneath the General Information tab. So that's how it would look in GUDID.

All right so back to the picture. So finish the top. And I told you I was going to jump around and I will. I'm going to go from the top now to the middle. We're going to go to labeler DUNS number just to keep the DUNS information flowing.

So we just talked about organization DUNS. And remember it is to identify the account.

Now the labeler DUNS has a slightly different purpose. The labeler DUNS identifies the labeler as shown on the medical device label. Allow me to switch over real quick to the next slide here.

Now if you remember we saw this slide earlier and I said a lot of the information for GUDID is on the label.

So in this case, I showed you on the bottom-left to keep remember the labeler name and DUNS number.

So as you see here I've highlighted. So, you see the labeler name and physical address that's on the medical device label.

So what we want the labeler DUNS to represent is the name and address as shown on the medical device label.

So the DUNS number that you give us has to have the same name and the same address in the DUNS database. So when I put your DUNS number, label or DUNS number in GUDID I would like to see to pull up this name as shown on the label and that address.

And in our helpdesk cases we're having some - we're seeing questions around this. So I wanted to take a moment to highlight that.

So I'm going to go back to my slide now. So it needs to identify the labeler as shown on the medical device label. So the purpose of labeler DUNS is that.

So this is also the labeler name and address that will be associated obviously to the DI record in GUDID. And again coming back to the account now a single account can have multiple labeler DUNS. Depending on how you label your products it make sense that you have more than one labeler DUNS.

Now again similar to organization DUNS if you use a labeler DUNS once in one account, you can reuse it in another account. And you can list your organization DUNS that you gave to identify your account as a labeler DUNS also.

Now let me kind of show you some screenshots to help to make some of this a little more clear for you.

So here we go back to Safeway Inc. We've establish the organization right at the top with the organization DUNS. And if you look down there is the regulatory contact. In the end in the bottom is see you see labeler DUNS tab. And I've listed nine labeler DUNS here.

And if you see the blue highlighted row that's basically showing you that the organization DUNS can be listed as a labeler DUNS.

So this particular organization now this account for Safeway in GUDID has an organization DUNS, it has a regulatory contact and it's got all the labeler DUNS that you would like listed.

So you would provide us all this information when you ask for the GUDID account.

So now this screenshot is just showing you how the labeler DUNS will be typed to your DI record. Remember the DI record is the device information for a given version or model of your device, that you're going to put into GUDID.

So in the case the labeler DUNS in that for Safeway Inc. will be available to whoever is entering the GUDID information.

If you see there is a dropdown on the left with the labeler DUNS number and you can choose whichever labeler DUNS is appropriate.

In this case I've put in a Labeler DUNS Number for a device. So I'm saying the company name is Safeway Food and Drug. The physical address is 8775 Cloudleaf Court in Columbia, Maryland.

So the important thing again is make sure that Safeway Food and Drugs and that address 8775 Cloudleaf Court are on the medical device label and are in the DUNS database for this Labeler DUNS Number. And that's what we want to see in GUDID.

It's a - it can be a little bit confusing so hopefully the screenshots help you.So we finished up labeler DUNS. Now I'm going to go back up this picture to coordinators.

So we're not going to switch from DUNS to sort of user roles in GUDID. So we talked about regulatory contact as not having the user role.

Now the coordinator user is different. This person will actually have a user role and a login into GUDID. And they are your gatekeepers.

If you remember in the beginning we talked about the labeler having control of who in their organization is going to access GUDID. And the coordinator is the user who manages that.

So they are the gatekeepers. They are the ones who create labeler data entry user accounts. And we'll talk about that. And they will take labeler DUNS and assign them to the labeler data entry users.

And a single GUDID account you can have as many coordinators as you want in your organization. And again you provide us this information and we create it as part of your account. I'll show you in the next slide here.

So again we're back to Safeway Inc. Safeway has, the account has been created as I showed you earlier. And now we're creating the coordinator.

If you look at the top left I've highlighted the coordinator user role. And on the bottom left you see for this particular coordinator we've assigned four labeler DUNS.

So this coordinator user is responsible to manage device submissions into GUDID for those four labeler DUNS. And so we create this for you. And that's the main role for the coordinator.

So what does the coordinator do? They create the labeler data entry users. So we're going to travel down the picture. And now let's go to labeler data entry users.

The labeler data entry users are your workers bees. They are responsible for day to day entry. And what they do is again they get assigned labeler DUNS.

So as a coordinator I have ten labeler DUNS under my purview. I could give two of them labeler DUNS one and two to as I've shown on the picture here to labeler data entry user X. And then I could give again two and three to LDE user Y.

So once an LDE user has labeler DUNS assigned they can only enter device records for those labeler DUNS. So when they enter their devices only those two DUNS will show up for user X and only two DUNS will show up for user Y.

And LDEs if they share a labeler DUNS labeler DUNS still is shared by user X and user Y. They can see all the records that they've entered for labeler DUNS too except for draft.

So this is something that you need to think through in your organization. Do you want everybody to have everything so everybody can see everyone's records or do you want to sort of (unintelligible) who should see what?

So these are some things for you to think about. We're here to assist you. But it is important you understand the roles and responsibility and the limitations of the different user roles in GUDID.

So here as coordinator user they're creating a labeler data entry user type in the screen shot. Again out of the many labeler DUNS, this user has only been given access to two labeler DUNS.

So when they go to enter a DI record those are the only two labeler DUNS that will be available to them.

All right so that's labeler data entry. Now the last bit we're going to talk about third parties.

So who are third parties? Third parties are companies and individuals who are authorized to submit on behalf of the labeler to GUDID. So you can decide to outsource all of this. But there is a slight difference to note.

If you are a web interface submitter then all you would do is you get the account established and then you hand off the role, the coordinator role or the LDE user role to a third party. So they do the entry for you.

But if you are an XML file submitter then you need to tell us right when you establish an account that you want to use a third party.

And the reason is again we want to make sure that when files come in through the gateway that authorized people are submitting on behalf of the organization.

So we will associate the third party to your account. And then the file consent if the submitter equals third party we make sure that that person is associated to your account. And if they are, we'll let the file process. If they're not associated, then we'll reject the file back.

So it's important you let us know who it is if you want a third party if you're going to use third party submitter.

So there you go. We've gone through this picture from top to bottom. We've jumped around a little bit but that was to hopefully help make things a little clearer.

Now I just want to take a moment on my slides I had a little blurb about what's applicable, not applicable to HL7.

So I just want to take a moment to talk about HL7 SPL submitters and GUDID accounts.

So HL7 as field submitters must have a GUDID account. You must designated regulatory contact. You must provide label or DUNS number and third party if it's applicable to you.

However what's not absolutely necessary is the coordinator user role and LDE user role. And I hope I've made it clear through the presentation that these are pretty much sort of the Web interface user role.

So if you are - if your main goal is to submit as an XML file then you don't necessarily have to have these Web interface user roles for their ID.

Now if you choose to have it, it just enables you to view your submissions via the Web. And next week we are going to come out with GUDID release 1.1 where in the UDI world I believe we had made a statement that we were going to enable companies to search for GMDN codes.

And we have added that capability and we hope to  release it next week. And that is only available through the Web interface.

So having the coordinator and an LDE user role will enable you to use that tool as well. So that would be the only reason for you to have coordinator and user role if you are an HL7 SPL submitter only. So think about that.

Now the other key is whichever submission option you choose to do your initial submission of a record you must use that same submission option when you do edit.

So if you entered a DI record using the Web interface you must go back and you want to make edit you have to use the Web interface.

If you send something as an XML file and you want to make edits you have to come back through to do the edits as an XML file. So that's something to keep in mind.

So just because you have Web interface access, don't use that role to make edits and send something as an XML and then make edits using the Web interface.

And our record-keeping issues also that may result for you where your source system may have different record versus what we have in the FDA.

But the focus of today's presentation is not on DI records. And we'll touch upon this when we offer a DI Webinar specifically focused on DI records.

So just to bring the slide back just to show you everything applies, the optional pieces for the coordinator and the labeler data entry user.

So as the HL7 SPL submitter we don't necessarily have to have those.

All right is that enough for everybody for a deep breath? That was a lot of information. I hope I didn't confuse everybody. (Unintelligible) question.

So we'll keep moving along. And now we're going to talk about how do we request GUDID accounts?

So assuming you understand everything I put in here make sure you take the time. Like I said, the account structure is very, very flexible. Think about how - what's best for you and your organization setup.

It enables you to set it up however you like it. We are here to answer questions. If you have questions send them to our help desk. Make sure you get DUNS numbers.

Now you may already have DUNS numbers. That's great. If you have DUNS numbers please take the time to verify the information is correct.

We've had people where we, you know, inform them that the DUNS number should match what's in the DUNS database.

But really the key to know if the labeler DUNS it should match what's on the device label. So that's important.

And if you don't have DUNS numbers it takes time to get DUNS numbers. We recently had a case where an organization got new DUNS numbers. They sent it to us but I could not pull it up for GUDID.

And the reason is there is a 30 day lag. Three's a refresh lag between the FDA copy of the DUNS database and the global DUNS copy. So the portion that we see there's a 30 day refresh lag.

So if you obtain a brand new DUNS today it may take 30 days before it shows up in FDA. So just note that. And if you do get a new DUNS let us know. And we have to have that 30 day wait period.

There is expedited options available for you to get DUNS. But still the refresh time to FDA still remains.

GUDID user roles, I've already talked about this. It's important to understand. And make sure the folks in your organization understand the functionality and what responsibility comes with each user role.

And for Class 2 labelers and labelers of devices like some of the PHS act you do need to have (unintelligible) listing numbers or a biologic license application number. So take the time to identify those also before you get a GUDID account. And I'll explain to you why in just a moment.

So how do you request the account once you have all of that together? Remember it sounds complicated but we're here to help you. So, you know, help is just a Web form click away. And we'll talk about that. So fear not, just send us your question.

So to request an account you start back very, very simple. You get it to our Web site and submit a GUDID account inquiry. All you need to do as you can see is this very simple form, your name, organization, email, phone and then you hit Submit.

We've even filled out the subject for you so you have no typing to do there.

Once you do that you get an email. In the email we're going to say we're going to give you a fillable PDF form which is the GUDID New Account Request document.

You fill that out and you hit direct reply for that email. It comes to us and the form looks like this. And you will recognize all things that we've talked about today, very familiar things at the top.

You see the organization DUNS number, organization name, the regulatory contacts. And if you notice in the bottom of the form here we ask you if you are a labeler of a currently marketed Class 3 medical device or a device licensed under  the PHS act.

And the reason is at the moment we're only giving accounts to these groups and mainly because we want to be available to assist. And these are the groups that are required to submit by the - by September of this year.

And you also need to provide us an FDA listing number. It's just a verification process for us to make sure that you got access and you have an active listing number.

And then in the next page you see we have labeler DUNS numbers that you need to provide us, coordinator information and third party information. So that's the information we expect from you when you ask for an account.

And once you fill all of that out and you send it to us we will review the information. If we have any questions we'll contact you.

We do go into the DUNS database to verify the information you have is correct and that we can see it. We look at the listing number, make sure that's active.

People are sending us listing numbers without the leading letters. So listing numbers usually have a leading letter so take the time to fill it out.

The more complete you make your information the less back and forth we have with you and we can process your request faster.

So we create the account. So what happens after we create the account? So let's again put it up. We'll talk about the Web interface first and then I'll come back to the HL7 SPL because there are slight differences.

So the Web interface folks obviously you would have given us coordinator accounts. We will create the GUDID account. We will create the coordinator account.

And the coordinators will then receive a system generated login email. And they can then login. They can create the LDE users, assign labeler DUNS to LDE.

And then the LDE users can login and create the DI record.

So I'm sure I've lost some of you so I figured I'd repeat the screen shots for you again. So remember you give us the Account Request Form and we create the account.

So here is a PA creating the same familiar account for Safeway. I put in the organization DUNS. I put in the regulatory contact. And then I add all the labeler DUNS which you also give us if you remember on the account request. And we add all of this in. Remember the labeler DUNS again has to match. The name and address should match what's on the device label.

And then we the FDA continue to create the coordinator account. And in this case we've chosen to assign four labeler DUNS to the coordinator. And you tell us what each coordinator should be assigned to.

And, you know, we don't really, really pick it. You tell us for this coordinator user I want these four labeler DUNS to be assigned. And we basically do what you ask us to do.

And the coordinator will get a system generated user name and password. So the user name will come in one email, password will come in a separate email.

As you can see here I have box. You can see the user name and the user role is also specified.

So the coordinator, the account has been created now and the coordinator has the login. So what do you do now right?

So now the coordinator can login. This is the gatekeeper if you remember. And they then determine who the worker bees are supposed to be within your organization.

So they have to create LDE user accounts. And then they assign the labeler DUNS to LDE users. So here we go. Here is the coordinator logging in. And the coordinator now said I'm going to assign two labeler DUNS to this particular labeler data entry user. So they could do that.

Now again the system will send automated user name and password to LDE user. The LDE user can then login and create new DI records. So that's sort of the process, seems very lengthy but it's fairly simple.

Now let me take a moment to talk about HL7 SPL submitters.

The difference here is the process itself is very similar but there is one more step for HL7 SPL folks.

Now HL7 SPL since these are XML files that are coming to us we need to make sure that your XML file is formatted correctly and all the exchanges through the gateway happen as they should.

So you've asked me to complete testing. And we've specified what testing is required on the - on our Web site and the implementation files.

So first request a GUDID test account. And you do the same request process, nothing different. You just tell us that you want a test account. We'll give you a test account.

And if it's applicable provide us third party information. Again we talked about how the coordinator and LDE user rules are not necessary. If you provide it we'll create those for you.

And once you complete testing we will promote you to production submission.

And a note here too that the ESG also has some testing and all - whether accepts submission or production submission, everything has to come through the FDA electronic submissions gateway.

All right so third party submitters, we know there are third party submitters out there either to develop solutions and have them tested. You can certainly do that.

We can give you a test account as well and you'll follow the same process.

And if you need testing data for certain attributes we can provide that to you upon request. And we ask that you also please make sure your DUNS information is correct.

And we currently have some solution providers testing with us on SPL and that's going well. And we welcome additional testers.

So the account's created and, you know, you are submitting data either via the Web or the XML. And something happens and there is a change now. Your regulatory contact leaves or you need to change your labeler DUNS. How do you do that? How do we make updates to the account?

So updates to that you need to go through us so let's say here anytime you want to update regulatory contact or coordinators, changing labeler DUNS, adding and removing labeler DUNS and updating third party information, all of this has to come through the FDA UDI help desk. And we will do it for you.

However, you can make your own changes if it only deals with LDE users or changing which LDE users have which labeler DUNS assigned to them.

And our recommendation is that you identify one individual in your organization to manage all GUDID account changes.

You know, we won't be able to say who's authorized and who is not. And as you see that's not information we're collecting.

So if it looks like it's coming from the correct individual and we can identify the user in our GUDID we would go forward with their request.

So it's a good idea for you to identify one person to manage all these changes.

In the future we are going to look to moving a lot of this to sort of more user based and electronic where you can do this yourself. But XML I mean this is the process we have in place.

All right so I know at least some of you are seeing that now. I hope you can see it and your brains are full. Certainly that's how we feel here at times. But stick with me. The end is near.

Let's talk about briefly about the status of GUDID. So at the moment we are reviewing comments. We've gotten excellent comments on the GUDID draft guidance document.

And I will come out and say there are some related to the DUNS numbers that we are working on. One question specifically that we're working on right now relates to a given device that is being - the exact same device is being labeled with two different addresses. But there's nothing different about that device except the device label has two different addresses.

So the question is would you submit one DI record or do you submit two DI records because the labeler DUNS in this case would be different?

We're working on that answer so stay tuned. We will come back to you as soon as we are able to. And we thank you for the  excellent comments that have come and we're working through them and try to get something out there as soon as we're able to.

Meanwhile we are accepting submissions from Class 3 labelers. I mentioned this before and labelers of devices licensed under the PHS act.

Again this is to enable us to be available to assist this group mainly because this is the group that is required to submit by September.

The GUDID search and retrieval is disabled. We are happy to open it up as soon as the database is - has some records.

Right now we have 21 production accounts and zero published, zero records that are available that are published. And we really want you to know that, you know, we're here to assist you. Please don't wait till the last minute, submit now.

You know, we don't want the rush in August September of this year. And we don't want you to be rushed and hassled. And we want to provide you assistance calmly and patiently and we can do that now. So please take advantage of it.

So how do you get started right? So with all this information there is plenty of information on our Web site. Take the time to read. And I know several of you have read our draft guidance.

We are noticing that some HL7 SPL folks are just looking at the HL7 SPL implementation files but are not looking at the draft guidance.

And the point is that the HL7 SPL document is a companion to the draft guidance. The draft guidance has comprehensive information about account structures and DI records. The DI record lifecycle it's very important to go through that.

The SPL implementation just tells you how to take the DI record and put it in the XML format but that's only a piece of the puzzle. So take the time to review the draft guidance, determine what options works for you.

And obviously gathering your data is a big piece of this. GMDN, we'll talk more about this when we do DI records. But the global medical device nomenclature preferred terms are required in GUDID.

And as I mentioned we hope to have a tool out next week that enables organizations to search. But that is not to say that you shouldn't go to GMDN and obtain preferred terms from GMDN. That's what we encourage you to do.

FDA listing number is required. And we are finding organizations do not always know who has the listing number and where that is. So take the time to identify that data. That's important.

And a quick note about data quality. We are very strong on data quality for GUDID. It's a brand new database and we want to make sure it serves as a quality database that can be counted upon and as a gold standard for device identification.

So we are putting in processes to monitor their quality in GUDID. And we ask that as you work to gather your data that you bake in those data quality processes. And if you want to talk to us further about it please send us a help desk request. We'd love to chat further with you on that.

So what do you need to do if you're a Web interface submitter at a very high level? You don't need to do any testing. Request an account. You know, get a GUDID account. Get familiar with the system, play with it.

You know, the system is built to enable you to create draft records. These are only visible to the user who created it, not to the public, not to the FDA.

You can submit records with a future publish date. So come get familiar with the system and get your accounts in place.

If you're an HL7 SPL submitter thing to do get a - register with the FDA electronics submission gateway, complete their testing.

If you already have an existing account you don't need to get another one. You can reuse it.

Request a test GUDID account, complete GUDID testing and then move on to production GUDID submission.

Just remember that HL7 SPL there is no draft DI state. It's not available.

So deep breath, we're almost there. Let's talk about easy things now. How do you contact us right? So to contact us you can contact us through the FDA UDI help desk for anything and everything UDI and GUDID.

But if you have specific questions related to the gateway for those HL7 SPL submitters please contact the gateway directly. And the email is on there and their Web site is full of information.

The UDI help desk is a Web based tool. You come in. You put in your question through the Web based form and then you submit your question.

And what happens is the question will become a case in our help desk too. And we will send you the response to the email address that you provide on the Web form.

And you can ask us follow-up questions. And please be sure that you can - get the emails from the help desk. Some of - we've heard some folks complain that it's gone to the Spam folder.

Finally GUDID is a system. And as you know all systems have scheduled down times. And we do too. We in fact had some (unintelligible) three weekends that we've had to take it down.

It will be going down this weekend again for as I mentioned enhancement release and also for some other maintenance that's taking place in the FDA.

We try to keep it to a minimum but it's not always under our control as other FDA systems we have to follow along their schedule.

So we will post all the scheduled down times on the GUDID Systems Status page. And unscheduled down times has not happened so far with GUDID. But if it does and you find the system unresponsive report it to us through the help desk or visit our Web site to see if they've already been reported and we posted information there.

And we also encourage you to subscribe to the GUDID email alert where we send a notice to you if there is a system down time. And we'll send you a notice if we update any documentation.

I sent a note out to subscribers about today's Webinar. So it's a good thing and we don't, you know, definitely our intention is not to Spam you. We want to give you meaningful information. So we encourage you to sign up.

And finally we are here to help you. Please know that everybody here wants to help. And if you need assistance or if you find, you know, gaps in the information we've provided and if there are, you know, barriers to submission that you are experiencing we want to hear about it.

So, you know, definitely we want you to get help desk questions. But we also want to hear, you know, any difficulties you have and how perhaps we can help you.

Again please do submit early. We want to know what issues our system has so that we can take care of them now versus waiting. And we have the ability to assist you like I said now in a more calm and patient manner versus later on in the summer when we have thousands of requests coming to us all at the same time.

So we're here to assist you so please submit early and thank you for your attention.

Heather Howell: Thank you Indira. We are prepared to take your questions at this time. The operator should be connecting with you and letting you know when your question has been queued up.

Coordinator: Okay thank you. We will now begin the question and answer session. If you would like to ask a question from the phone lines please press Star 1. You'll be prompted to unmute your phone and record your name.

Again it's start 1 to ask a question. One moment please for the first question.

Our first question comes from (Kathy Hodren). Your line is now open. Would you please check your mute button?

Scott Hall: Sorry, yes. This is actually Scott Hall from B Braun Medical. I have two questions. One is related to the communication expectations from the electronic submission gateway.

In previous public meetings it had been indicated that all communications from - that for submission through the electronic submission gateway would go through the third party if you used the third party. Is that still accurate?

Indira Konduri: No it's completely up to you how you want to set it up. If you want a third party to do all the submission through the electronic submission this is (unintelligible) how it's set up that way.

But if all you want the third party to do is to sort of give you a plug-in if you will of a XML generator and you do the submission via the ESG you could do it that way also. So we don't, you know, it makes no difference to us.

Scott Hall: So...

Indira Konduri: And just remember that the third party needs to be associated to your account.

Scott Hall: My question's actually related to the communications back from the FDA, for example acknowledgements or errors. Are those expected to go through the third party or would they go directly to our coordinator?

Indira Konduri: It's whoever is, you know, whoever sets up the exchange. If the third party is actually dropping the files and their server or they are submitting using the Web creator in gateway then the communications will go back that same route.

So however you set it up. If it's the UR label organization server communicating with ESG then that same server will receive the acknowledgement. Does that make sense?

Scott Hall: Yes. And if you have compliance questions you would go directly to our regulatory contact?

Indira Konduri: Right.

Scott Hall: Okay. My second question's related to the submission of records via the Web interface and corrections via the Web interface or through the ESG. You indicated that they needed to be maintained the same.

In that case if in the future and so if we make a submission via Web interface forever we would need to make corrections in the Web interface or could we use a third party or the ESG to do that update?

Indira Konduri: So I didn't want to get into the details of the editing which can get pretty complicated because this presentation was focused on accounts.

So the answer to your question is you submit something through the Web interface if you're familiar with the grace period concept for the DI records you need to - if you plan to edit during the grace period you have to use the same submission option you used for the initial submission.

So if you submit through the Web interface during the grace period you should only use the Web interface to make the edits.

After the grace period you can definitely use either option. I think to be simple and consistent I didn't want to get into too much of the detail because we haven't talked about grace period in today's presentation.

So that's the answer is however you submit initially, during the grace period you have to use that same option.

After the grace period yes you can use either option.

Scott Hall: Good.

Indira Konduri: Does that help?

Scott Hall: Yes thank you.

Indira Konduri: And we'll talk more about this in a later Webinar. When we get into the DI records we'll make sure that we address this specifically.

Scott Hall: Thank you.

Heather Howell: Thank you. We'll take our next question.

Coordinator: Okay. Our next question comes from (Lawrence Potter). Your line is now open.

(Lawrence Potter):  Yes, good afternoon. I'm a manufacturer of a Class 3 medical device. And I know that this is not specifically towards accounts.

However when we change our graphics to include the bar code requirements of UDI does that necessarily indicate a PMA supplement for our Class 3 device as far as labeling goes?

Indira Konduri: I'm not sure if I understood your question correctly. You know, maybe it's better if you send this question to us as a help desk question so we can make sure we address it correctly.

(Lawrence Potter):  Yes that'd be fine. I'd appreciate it.

Indira Konduri: Okay thank you.

Heather Howell: Our next question please?

Coordinator: Okay our next question comes from (Besky) - excuse me, (Becky Nowaski). Your line is now open.

(Becky Nowaski): Hi. I have a question about the average turnaround time for new account opening. I know in the email it said that it's about a ten business day turnaround. But just wondering if you're getting an influx of new accounts if that's taking longer than normal?

Indira Konduri: We are turning to turn them - we are trying our best to turn them around within ten days. But occasionally you may see it take a little longer. And we apologize for the delay.

If you want to ping us again or give me your help desk case number we'll definitely look at it. We apologize. You know, we are trying. That's our SLA is ten days. And we're trying to stick to it.

(Becky Nowaski): Okay thank you.

Heather Howell: Next question please?

Coordinator: Yes our next question comes from (Nathan Hardessy). Your line is now open.

(Nathan Hardessy): Yes. So in determining the options for our submissions we're trying to figure out what some of the advantages are because from our understanding the HL7 option you can't do batch records.

So we're trying to figure out what is the advantage truly of doing the HL7. The gateway's been fairly difficult for us to implement for certain pieces.

So we were looking at Web based. But knowing that we would have to during the grace period only use Web based now we're trying to figure out what our options are, what the best options would be.

Indira Konduri: So at a general level I would say the Web interface is probably more suitable for if you have, you know, not a very large number of device records, a high volume of device records you're trying to submit.

If you have a high volume then probably the XML option may be more suitable. Again it's completely up to the labeler which way you go.

The XML option is probably more resource intensive to set up initially. But once you set it up hopefully it should go smoothly. You will be able to identify issues during the testing period.

With regards to updates I don't believe that's such a huge issue. Again I didn't get into the details of that mainly because you have to really understand the DI record lifecycle to talk about it.

And we're happy to have an offline discussion on this with you if you would like. Just send a help desk request and we can really talk about it in detail.

But in general I would say the Web interface is more amenable to small volume submitters. The XML is good for high volume submitters.

Yes you cannot batch in an XML. But what we've found from prior electronic submission experiences companies in fact preferred to have non-batching capability. They like to know that this record, this file that they sent passed so they can checkmark it and this record they send failed and therefore they have to fix just that one file versus sending ten files in one XML, ten records. If you had five records that passed then, you know, two that failed or five that failed then you have to figure out.

The tracking was I believe companies found that harder to manage.

(Nathan Hardessy): Okay.

Indira Konduri: So even though we said batch submission is not possible remember you can dump ten files all at once for the gateway to pick up. You don't need to do one file at a time. You can dump ten files in the gateway folder for the gateway to pick up at once.

(Nathan Hardessy): Okay thank you.

Heather Howell: Next caller?

Coordinator: Yes. Our next question comes from (Julie Byerly). Your line is now open.

(Julie Byerly): Hi, thank you. My question concerns the GMDN nomenclature that you mentioned that's part of the account set up and also entry of the DI record.

It's two part. I know that you said that there would a plan to have free access to those codes. I'm assuming it's unavailable now but it would be in the future. Is that - was that - do I hear that correctly?

Indira Konduri: I'm sorry, did I hear you correctly? You're saying it would be what access to the codes?

(Julie Byerly): I thought I understood form the slides and from one of the other presentations that was on the FDA Web site that the GUDID database would provide free access to searchable access to those codes?

Indira Konduri: Right, you are right. That's correct. We're actually working on it and I'm hoping to have that out next week. And it will only be available to logged in users.

So we're not making it available publicly. So if you're a public user you can come in and search for the GMDN codes.

But if you are a logged in user of GUDID which means you have an account and you are a labeler and you have a need for these codes to submit the DI record you can come in and you will be able to search for the GMDN preferred term.

And we will give you an FDA preferred term. We cannot release the actual GMDN code but we plan to make available an FDA code that's not through the GMDN code.

So that's the tool and we hope to have it out next week.

(Julie Byerly): Okay so and related to that if we've used the GMDN code in the past for a product so we have a code that we believe is the preferred nomenclature is the expectation that the product label description of the device matches that GMDN code exactly?

Indira Konduri: That's a great question. I don't believe the expectation is that it should match exactly. I think it needs to be for that device.

You know, it has - it's not - GMDN is actually not required on the label.

(Julie Byerly): Okay.

Indira Konduri: So no, it doesn't have to match.

(Julie Byerly): Great, yes. Ours is similar but it's not exact so...

Indira Konduri: Right.

(Julie Byerly): ...that answers my question, perfect.

Indira Konduri: Okay.

(Julie Byerly): Thank you.

Heather Howell: Next question please?

Coordinator: Yes, our next question comes from (Kathy O'Keefe). Your line is now open.

(Kathy O'Keefe):  Hi. We're currently manufacturer a medical device which is Class 3. But we have petitioned the FDA and are waiting to hear a final decision about making it Class 2.

If that happens are we required to do the registration to get an account or do we have longer waiting period? What's the plan?

Indira Konduri: This is a good question. I don't know the answer to this. I would suggest that you send us a help desk request so we can make sure we, you know, give you the appropriate answer.

If it's Class 3 of course you must submit by September of this year. You know, if it's to be classified before then I would think that the appropriate timeline applies for you.

But send us a help desk request and we'll be sure to give you the correct answer.

(Kathy O'Keefe):  All right thank you.

Heather Howell: Next question please?

Coordinator: Our next question comes from (John Dore). Your line is now open.

(John Dore): Hello. This is (John). If I - if we were to use the XML option is - and then actually go into the Web interface to use some of the features there not to do updates does it create the sub accounts for the labeler DUNS if - in that process?

I mean how does that - how is the interaction between those labeler DUNS creation if you use the XML option?

Indira Konduri: If you use the XML option you give us of course you have to give us a labeler DUNS. And then you can submit XML for any of those labeler DUNS.

So your device record in the XML would be associated to one of those labeler DUNS. So that's the SPL.

Now on the Web site if you want to have access to the Web site you have to give us the coordinator user and assign which labeler DUNS you want them to be able to view records for.

And then they would create LDE user who can then also be associated to labeler DUNS.

(John Dore): So by submitting via XML the labeler DUNS that you put on the XML files don't automatically create sub accounts under your primary DUNS number. Am I understand that correctly?

Indira Konduri: Right. So the labeler DUNS would be under your one account. The - they don't - the subaccounts, there are no subaccounts for a GUDID. It's just that one account. And the one account will have multiple labeler DUNS.

(John Dore): Right.

Indira Konduri: And the only thing perhaps what you're thinking is how - which DUNS you assign to which coordinators.

You could assign all the labeler DUNS to one coordinator and all of them to a labeler data entry user. So when you submit the record via XML you want to view that on the Web interface. as long as that coordinator can see that labeler DUNS they can see it on the Web site.

Did I answer your question?

(John Dore): Maybe but I'm not understanding because I was thinking that if you submit your - if you have labeler DUNS meaning you have many different addresses that are using, that are creating the same device then you would have many labeler DUNS under your primary account.

Indira Konduri: Right.

(John Dore): And those would be populated. When you submit the via XML that would all come into the system. And if I were then to go in through the user interface would I see all of the labeler DUNS?

Indira Konduri: Yes you would but I think you made one key point there which is that the same device has many addresses. Is that what you said?

(John Dore): If more than one location was producing them.

Indira Konduri: Right so we're - if you recall during my presentation one of the guidance comments we received is we're working on that exact same issue.

Because right now in GUDID a given version or the model of the device it only has one labeler DUNS associated with it.

So we got - we have a question that we're working on...

(John Dore): Oh okay.

Indira Konduri: Right.

(John Dore): Maybe I didn't understand that question. I was thinking if you changed the address would you need to change the - when you mentioned that question I understood it as if you changed the - your labeler address for - or you labeler DUNS address changed, not if I just started with two or three different.

Indira Konduri: Right. No the question we're working on is one device being labeled with two different addresses if they exact same device.

And in our DI record can only have one address associated with DI record.

(John Dore): Okay.

Indira Konduri: So we're working on that. And to address your other question can you change the address? Yes you can. After the record is submitted you can come in and change the labeler DUNS and put a different one in for that DI record.

(John Dore): But then it may not match your - what you've labeled.

Indira Konduri: Oh it should be - I guess...

(John Dore): You'd have product that's already in distribution at one - under one address. And now you would have a different address. So the human readable piece would not match if you linked to that Web site.

Indira Konduri: Now that's an interesting twist, very good question. I think you should submit that as a help desk case. We didn't think about the changing labeler DUNS and then products out there which may already have another address.

So definitely submit a help desk case on that so we can...

(John Dore): Okay.

Indira Konduri: ...factor that into our discussions and we can come up with an answer for you.

(John Dore): Okay. There's a lot more where that came from in...

Indira Konduri: Sure, sure.

(John Dore): But thank you.

Indira Konduri: You're welcome.

Heather Howell: Thank you. Next question please?

Coordinator: Our next question comes from (Sumit Padway).

(Sumit Padway): Hi. My question is also related to the change in DUNS number. We are planning to move to a new location in 2016.

So do we have to start from scratch like request all the accounts with the new DUNS number? Or will we be able to make a change in the accounts that we currently have like the GUDID coordinator and labeler data entry?

Indira Konduri: You should be able to make the change to the account that you already have.

(Sumit Padway): Okay thank you.

Heather Howell: Thank you. If there are any further questions?

Coordinator: Ms. Howell there are no further questions in the queue.

Heather Howell: Okay well thank you again for participating in the call today. Please provide any further questions to the UDI help desk and visit the CDRH Learn section of our Web site for further information on UDI and other medical device regulatory issues. Thank you.

Coordinator: This concludes today's call. Thank you for participating and you may disconnect at this time.


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