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Moderator: Tammy Wirt

03-24-14/9:00 am CT

Confirmation # 2016727

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NWS HHS FDA CRDH

Moderator: Tammy Wirt

March 24, 2014

9:00 am CT

Coordinator: Welcome and thank you for standing by. At this time all lines are on a listen 

only mode. During our Q&A session you may press star one on your 

touchtone phone if you would like to ask a question. Today's conference is 

being recorded. If you have any objections you may disconnect at this time.

Now I would like to turn the meeting over to Ms. Heather Howell. Ma'am you 

may begin.

Heather Howell: Hello and welcome to today's FDA webinar to discuss recent changes to the 

clinical laboratory improvement amendments CLIA submission process. I'm 

Heather Howell, the Deputy Director of CDRH's Office of Communication 

and Education. FDA has established new processes for tracking submissions 

that require CLIA categorizations and is formalizing the (unintelligible) 

waiver by application program. To reflect these changes we have updated the 

guidance documented titled Administrative Procedures for Clear 

Categorization Guidance for Industry and FDA staff.

In addition on March 21, 2014 we will update the internal electronic system 

which will affect the way in which submissions will be tracked. Today the 

Deputy Director of the Office of In Vitro Diagnostics and Radiological Health 
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Don St. Pierre will provide clarification on these changes and will answer 

questions following his presentation. Also with us today to assist with the 

Q&A portion of our webinar are several other subject matter experts from 

CDRH's Office of In Vitro Diagnostics and Radiological Health.

Following the webinar the side presentation audio recording and written 

transcripts of today's program will be available on the CDRH Q&H section of 

the FDA Web site. Now I give you Mr. Don St. Pierre. Don?

Don St. Pierre: Okay. We'll try to get this going fairly quickly so that people can enjoy the 

rest of their afternoon not having to listen to me. So today let me see. Why is 

this popping up? Okay so today we're going to go over the updates to the 

CLIA program.

As Heather said I'm the Deputy Director in the Office of In Vitro Diagnostic 

Devices. So I think probably many of you know me and after today many 

more will know me. So we're going to go over the background of CLIA for 

those people that don't have the history of that. I think most of the people 

online probably do. More importantly what's going to be changing with CLIA

and what it actually means for stakeholders. So that will be our three main 

topics.

For the background of CLIA, CLIA was proposed back in 1988 to establish 

quality standards for our laboratory testing and then those regulations were 

finalized in 1992. This was a program that was actually run by CMS, our 

sister agency, and FDA does just one piece of this for CMS which is CLIA 

categorizations. So in 1999 there was an FR notice transferring these - this 

categorization responsibility from CDC to FDA.
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So for the last 15 years we've actually been - it's kind of been a tri-agency 

effort with CDC, FDA and CMS all kind of working together to do these 

CLIA categorizations. So it's actually for having three different agencies with 

three different perspectives it's really been an informative and really 

productive working relationship for the three agencies. So I think it's become 

a really good program and it had a really good basis from its start with CDC 

setting up how to go about categorizing and such.

In 2008 we actually issued two guidance documents. One was the 

administrative procedures guidance document for CLIA categorizations. This 

was the one that's the subject of today's webinar but a separate guidance was 

on recommendations for CLIA waiver applications. So CLIA waivers by 

application get a special attention from FDA I think as most people know. So 

we kind of treat them a little bit differently because there's a lot of work 

associated with those and they're not kind of the routine types of reviews that 

we do for other types of categorizations either high or moderate or those parts

that are waived because of the regulation.

So we're not going to be talking about the criteria for waiver just the 

administrative procedures and the IT systems that support those administrative 

procedures. And in 2012 we actually negotiated new (unintelligible) with the 

medical device industry and as part of that they wanted to include 

performance goals and other things related specifically to CLIA labors by 

application. So our administrative procedures have been updated to 

incorporate those discussions from - or those commitments from that user fee 

negotiation.

So what gets categorized? Well any device that - any IVD that FDA clears 

through the parts and (unintelligible) process, approves through the PMA 

process or an HDE process or a (De Novo) process. So all of those products 
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get categorized by FDA. Also the same IVDs or similar IVDs that are cleared 

or approved by CEVA or licensed by CEVA those also get categorized by the 

FDA as well the - this is you're talking about CLIA categorization which is a 

different statutory requirement, a different agency that we're actually doing 

work for.

Even though products that don't require a 510K review or a submission to 

FDA to get an FDA decision they still require a CLIA categorization. So you 

could have devices that are exempt from FDA review that would still come in 

to get categorized for CLIA.

And a thing that happens all the time which I think this guidance document 

helps out a lot with if people actually use it is when companies change names 

or change distributors and change labeling and stuff. A lot of times for IVD 

products that can affect a lot of different products at once. And in the past 

FDA had to do that, you know, one by one and enter those manually into the 

database, so creating those records independently.

We've now actually had a way and we've been using this by policy but it 

hasn't been written down anywhere where we allow companies to actually 

submit a spreadsheet with all of those changes for all of those products so that 

all of them get loaded up into the public database rapidly and accurately. So 

that's been a big help for industry and everybody that's used that has really 

liked that on industry side as well as FDA side. So and of course IVDs that are 

legally marketed for responses are seeking a waiver categorization. So those 

are the waivers by applications.

So how are IVDs categorized? Well so you've got legally marketed IVDs. So 

they're either cleared or approved. They're licensed by Biologics or they're 

exempt, are categorized. The high and moderately complex devices that's 
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pretty routine. It's pretty standardized. It's very usually, you know, nothing, 

you know, novel or interesting about those. They're all based on an objective 

scoring system.

We probably over the 15 years we've been doing this have maybe a handful of 

issues related to high or moderately complex categorization that we've done.

Usually it's due to a misunderstanding. So either FDA got it wrong or industry 

presented it wrong. These are usually simply and easy things to resolve. So it's 

not a big deal. So that's not a part of the program that anybody really has 

many questions on as far as getting their categorizations. Those are usually 

right and they're usually quick and never a problem.

We also have products that are waived products. So and there's multiple ways 

to get classified as waived. So you could be waived by regulation. So in the 

regulation it cites nine types of tests that are automatically waived. So FDA 

doesn't do a review of those to say okay this is waived or not. They're waived 

automatically so you get the letter saying you're waived by regulation.

There are other products that FDA either clears or approves that are for over 

the counter use or more, you know, a common - a more common term is home 

use. So products that people can use in their home are - should not be that 

complex because people don't have the training to use - to be able to 

understand complex systems for those products. So if you can use them in 

home then they should be pretty simple. So those are also automatically 

waived. So if it's one of the nine cited in the regulation it's waived. If it's 

creator approved for home use it's waived. Those things happen automatically.

The one that doesn't happen automatically is the waiver by application. So and 

that's the one that is the subject of that second guidance which we're not going 

to be talking about today.
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So those documents - those devices that companies submit and request waiver 

by application those require clinical data. That's a whole separate review and 

it kind of takes on the kind of the persona of kind of like an FDA review of a 

510K or a PMA. It's kind of more PMA like because the data requirements are 

a lot more onerous for a CLIA waiver then they would be for a 510K or such.

So it's really important to understand because I think industry sometimes has 

the misconception that if they get - if they demonstrate substantial equivalent 

that that should be good enough to also demonstrate waiver and they are two 

different animals and they shouldn't be confused and they shouldn't be 

associated with saying, you know, one gets you the other because it certainly 

isn't the case.

So what is changing? One we have administrative tracking mechanisms.

Those are coming about because of (MDUFMA) commitments that came out 

in 2012. In addition we're updating our CLIA administrative procedures to 

provide some of the other things that we basically have learned since 2008 to 

document how we're actually doing things today and also to provide that 

opportunity for people to change - make multiple changes by submitting a 

spreadsheet of all those changes rather than having FDA and sponsors do 

them independently.

So what's changing or what's about to change? So in 2012 FDASIA or - which 

was MDUFA user fee negotiations were part of FDASIA. And industry 

wanted some commitments of - on FDA's part for CLIA waivers by 

application. So it's not the high complexity issues. It's not the moderately 

complex categorizations. It's not the waivers by OTC or home news. It's not 

the waivers by regulation. It's that very small subset of CLIA waivers by 
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application that industry was hoping to have performance criteria established 

around.

So, excuse me. So that's kind of one of the major drivers of the new IT system 

as well as another thing that came out in the MDUFA negotiations which was 

being able to do a dual submission which was actually doing the 510K and a 

waiver by application in the same submission at the same time. So which is a 

totally new and different process certainly than we've used previously.

So in 2012 we started implementing these commitments for CLIA waiver by 

applications. We - it took us about a year and a half to develop a new IT 

system to kind of track and report on these commitments. It's important to 

understand that CLIA waivers and - or CLIA reviews and categorizations 

were totally separate - are totally separate from FDA decisions because the 

CLIA comes out - those decisions come out under with respect to this CLIA 

statue in CMS versus Food Drug and Cosmetic Act and the FDA.

So that's totally different animals. We've kind of tracked since the - since 

getting this program in 1999 we've kind of tracked everything through the 

FDA submission. So that makes it really complicated because you can have 

tons or hundreds of CLIA applications or changes that relate - a CLIA 

categorization for each 510K or each PMA. So it's hard to kind of track them 

under one tracking number.

So this new IT system basically is allowing us to track all of our CLIA work 

and anything related to CLIA separately from all the FDA work which is the 

510Ks and the PMAs but it links the two systems. So we'll still have that 

linkage and everybody will still be able to see that linkage and know what that 

linkage is but we'll be able to track each individual CLIA categorization 

action that we take.
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So in - starting on March 21, fingers crossed, the new IT system will be 

implemented for CDRH and this will have all this new tracking system for the 

CLIA work that we do. And that new IT system will not only track each 

individual CLIA activity that we do it'll also - it's also set up to monitor and 

track our performance as we negotiate in 2012.

So all of those things are tied up into this new CLIA administrative 

procedures guidance and it talks about - it introduces some new language or a 

new tracking system that will be - that industry will see as well as everybody 

else will see because this tracking number will be in the public database. So 

not a great worry for anybody per se but any time you - something new pops 

up and people don't know what it is it causes questions. So hopefully we'll be 

able to answer all those questions today.

So what is changing? So here we have, you know, again I kind of went 

through all of this. These are the different types of CLIA categorizations, the 

things that we do. So it's devices that are approved or cleared by CDRH, 

devices that approved, cleared or licensed by CBER, devices that are even 

exempt from FDA review but still need CLIA categorization. And then all of 

those changes after a product is out in the market, all those product name 

changes or distributor changes or company changes, all those changes that 

come in as industry would see as add to files to either a 510K or amendments 

to PMAs all of those things will now be getting a CR number which is a CLIA 

- which we refer to as a CLIA record.

So starting March 21 companies will be getting - when they send us their 

510K, PMA or De Novo application where those are basically the parent 

documents as far as CLIA is concerned. So when they submit those you'll get 

your acknowledgement letter for your 510K, PMA or HDE or De Novo
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application just like you normally would but you'll also be getting a separate 

letter saying that we've also find a clear record number to this application. So 

you'll get separate communications for both of those.

Same happening for - through any submissions submitted to CBER and for 

exempt - submissions that are exempt and there is no parent document, so 

there is no 510K or PMA number. You'll just a CLIA record number. So those 

X files that we created for exempt files, those who are kind of basically 

dummy documents for us just to have something to track, there was never an 

FDA really - there was never a FDA submission associated with that. It was 

just for the CLIA. So now we'll just have a CLIA record number which is a lot 

cleaner. Excuse me. And of course when companies add to files those add to 

files will get logged in as a CLIA record.

So if you are changing your - the device name and you submit an add to file to 

a 510K we're not asking you - the companies to do anything different. It's just 

that's going to get logged in and be assigned a CLIA record number, a CR 

number.

So we also have here the CLIA waivers by application. So this is that very 

small subset of applications that we get, maybe 10 or 12 a year. Expect that 

that will eventually go up but right now it's probably averaging about 10 or 12 

a year. So for those particular devices they're going to be handled in a similar 

way but they're going to be given a CW number. So these are CLIA waivers 

by application because these require a substantial review of data and an app -

a specific application that the company submits to us with all these data to 

support waiving their product.

Then that's kind of given a different number and MDUFA actually asked that 

we track and report out on these. We've kind of - we've given it a separate 
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designation so that these are easily identified in the database and can easily be 

pulled out. So it's the same thing. They're still all going to be associated with a 

parent document. So whether it's a 510K, PMA, BLA, what have you it'll have 

those parent documents except for of course if the device is exempt from FDA 

review and there is no parent document, there is no submission then it'll just 

get that CLIA waiver, CW number.

So all that's coming into play starting on March 21. So the other thing with the 

tracking system so it's not only to capture all of our CLIA work and all of our 

CLIA waiver by application it also captures the - a new program that was 

started with FDASIA or MDUFA three which allows companies to submit a 

dual application so their 510K and a CLIA waiver by application.

Prior to this companies had to get their product cleared or approved or 

licensed by FDA and that would do the CLIA work so because you had to 

have a legally marketed product. So you had to do the FDA piece first to make 

it legally marked and then you did the CLIA piece. Well this allows 

companies to do their 510K and their CLIA waiver studies all in one 

application. So it's kind of important to industry because they were like if their 

product is not waived then they - it's not a real viable product. So they needed 

- the waiver was very important and it was as important or more important 

than the FDA clearance or approval.

So for those subset of documents where that's important that they both happen 

at the same time then this is an added option for those companies. This is a 

difficult process. We've piloted this before and it is difficult because the 

applications kind of feed off of themselves. So if you make changes to your 

FDA document, your 510K or PMA, that could impact your - the information 

or the studies that you need for your CLIA waiver application.
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So it was, you know, it's very difficult to do this unless you set it up well from 

the beginning which is why in the MDUFA commitments we made the -

doing a pre-submission mandatory because that's the only way to kind of -

that's the best way that we knew how to try to guarantee success or make 

success more possible because without that we don't think these would end up 

in a very - in a positive state. So we'll go over that a little bit more later.

So the - what the MDUFA three has done is it's set up performance goals for 

CLIA, waivers by application. So and this slide shows what those 

performance goals are. These performance goals although it had never been 

really applied to CLIA categorizations before again because CLIA was - we're 

doing that for CNS and it's not like an FDA responsibility for, you know, 

clearance or approval.

So but what we've - but kind of what we did was devise similar performance 

goals as for the FDA part of our work even though CLIA has never been 

associated or has never been tracked that way and kind of adapted that system 

because industry actually understands what the MDUFA goals are. That 

makes sense to them. The process makes sense to them. So we might as well 

have CLIA categorizations use the same process.

So talking about the dual CLIA waiver - dual 510K and CLIA waiver by 

application this has its own separate performance goals and there are 

requirements. You have to actually have a pre-submission. So when you 

submit your 510K you should be identifying your - the pre-submission that 

you had, that you worked out the plan with FDA on how you were going to go 

about doing this to improve your chances of being successful at the end.

And we have our performance goals that are associated with this. They are a 

little bit longer because basically FDA is doing two reviews. We're hoping 
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that at some point the two reviews will merge into one but quite frankly that's 

probably idealistic because, excuse me, the studies require to obtain a CLIA 

waiver is so much more burdensome than the studies required to demonstrate 

substantial equivalents.

So because of that, you know, it's probably why we were thinking that this 

would be limited to those - that small subset of products that are not really 

viable if they are not waived. So if it's not one of those - in that small subset of 

products then you're probably better off getting your FDA decision and then 

doing your CLIA because at least you have something that you can market 

and you can make money on your marketed product and then you'll work on 

getting your CLIA waiver by application in addition to that so.

So and to provide greater transparency during the MDUFA negotiation we 

said we would update our procedures to kind of make this new review of 

management expectations clear for waiver by application and the dual process 

because these are all new, not only to industry but they're also new to the FDA 

staff having these performance goals, meeting these certain expectations. So 

that's an entirely new animal for FDA staff and being tracked on these 

performance goals for these types of submissions.

So updates to the guidance document it - the guidance document explains 

what a CLIA record or CR number is and when it will be assigned. It includes 

time frames. It includes instructions for submitting these requests to FDA as 

well as the multiple categorizations and I would like to highlight this because 

this is a huge timesaver for industry and it's a huge timesaver for the staff here 

because it allows them to enter multiple records, whether that's 100, 200 

different records, all at once rather than creating and going into 200 separate 

records and creating those documents. So this is a huge timesaver.
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The benefit for industry is you're actual categorizations that go - that are in the 

public database actually happen a lot quicker if you do this because that could 

take - it could take a long time for FDA to enter all of them in. And the 

guidance documents talks about the CLIA waiver number or the CW numbers 

that will be assigned and what those expectations are of staff and industry for 

actually making that process happen smoothly.

So expectations for CLIA waivers by application, the submission should be 

sent to CDRH. You should still be referencing your creator approved product 

or your 510K or your PMA because you have to basically demonstrate that 

you actually have a legally marketed product. And now I think industry, 

although the e-copy program had its trials and tribulations very early on, I 

think a lot of those things have been worked out and this has been working 

much better now.

Since everything has - all the FDA's documents pretty much have to come in 

through e-copy it wasn't something that we negotiated in the MDUFA three 

negotiations but since companies know how to do this now and it does 

expedite the process it's well to your advantage to actually submit your CLIA 

waiver by application via an e-copy. If you did it for your FDA submissions 

you should know how to do it for this.

So and when you do that FDA will send you an email or correspondence 

assigning you your CLIA CW number, the tracking number and that's the 

number that you would refer to in future conversations with FDA and that's 

the number that FDA will use. Again our database will link this to the 510K or 

the document. So for these types of submissions FDA is going to do its initial 

review within 90 days and either request information and put the file on hold 

or just interact with you thinking that you've done such a great job you'll be 
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able to get this done in that one cycle, in one round, and complete your 

application and at the end of that hopefully get your waiver granted.

FDA - so once you submit that information it will come in with a CLIA 

waiver supplement. There will be a CW with X, you know, six numbers and 

then a flash with a supplement one or however many supplements it takes to 

get it done. And so and then at the end of that process by day 180 you're either 

going to get - you're going to get your decision on that waiver application. It's 

either going to granted or it's going to be denied. So right now I think we're 

probably running 50/50 for the ones we grant and the ones that we deny.

So but I think the companies that actually go through the pre-submission 

process and work with FDA up front in setting up their protocols and 

understanding what's actually required to get CLIA waiver those companies 

tend to be - tend to do better during this process. So once we make that 

decision we post that decision in the CLIA public database saying that the 

waiver has been granted. That's kind of what industry is looking for to have 

that in the public database so that everybody knows that the product has been 

waived.

So for our dual application this is one where you must have a pre-submission.

They must have done the pre-submission ahead of time and then you'll 

reference our pre-submission in your 510K and that 510K will contain not 

only the data and information necessary to get substantial equivalence. It'll 

also - these will contain all the information for the CLIA - to get CLIA 

waiver. So all that information has to be in that application at that time.

There's no staging of the information. There's no okay well I'm submitting my 

510K now. I'll give you the waiver, you know, and I wanted this to be a dual 

but I'll give you the waiver information later. None of that. It has to all be in 
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that submission at the time you submit it. And this because it's coming in as a 

510K annual waiver application this is good to be copied. So these actually 

have to come in in the copy.

So when you do this we're actually going to assign two numbers. So we're 

going to give this a CLIA waiver number and a 510K tracking number. So 

that way we can capture and track performance on both our 510K 

performance as well as our CLIA waiver performance and it's important for 

these particular applications to have kind of independent tracking. Hopefully 

all these tracking dates and numbers will all be the same because they're being 

reviewed at the same time but it's a possibility that there could be some 

differences there. So for these types of applications it's coming in as a 510K 

so basically we'll be following our refused step policies for 510K and such.

So FDA will complete our substandard review of this within 90 days and 

again either put it on hold asking for additional information or say that we 

think that this has done well enough that we can get this done in one round 

with the company at the end of that or if you don't hear from us at all then 

you'll get - what you'll hear is that your SE and your waiver is granted. So 

okay let's be honest. The likelihood of that happening is not great but it is a 

possibility.

So if we ask for additional information then that information will come in at a, 

you know, you'll submit that information as a supplement. And then within 

210 days, this is longer than just an FDA - a 510K review because we're 

basically doing a review of both (unintelligible) things at once. So we 

extended the days out a little bit. So by day 210 you'll actually - you'll get 

your decision. So that'll either be your SE and your waiver is granted or your 

NSE and your waiver is denied. So it's better to get the first one. So and of 
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course if you are SE and your waiver is granted we will post that in the public 

database.

So updates to the guidance really there's no changes to the scientific review 

process. So like I said if it was a - so the scoring mechanism to get your high 

complexity, moderately complex or waive categorizations those will all stay 

the same. The criteria to get your CLIA waiver by application that is all 

outlined in that separate guidance document. So that's not - again that's not the 

subject of this webinar.

So even if you're not doing a CLIA waiver or a dual submission and you just 

want to do a CLIA waiver or something you can still submit - do a presubmission and actually we would probably recommend that you do that to 

get feedback on what studies you're planning to do and your protocols for - to 

support your CLIA waiver. So I think it's - really is a good idea to do that.

We've got a lot better in our pre-submission interactions and it seems that - it 

seems our industry really likes that and those things are going better than they 

have, you know. Many years ago I don't think we actually did a great job with 

our pre-submissions. Now it's a much more standardized process. There's 

clear expectations of what to get out of them. So I think if you haven't done a 

pre-submission in the recent past then you may want to give it a try. It does 

allow great interaction between FDA and the sponsors and it can be multiple 

interactions. So it sets up that dialogue between FDA and the companies 

which is important.

So what does it mean for stakeholders? So we're going to talk mostly about 

industries, sponsors of these applications but also there will be some changes 

that the clinical labs and CMS will see or auditors - CMS auditors will see. So 

we'll go over those. Sponsors will receive a pre-market tracking number. So 
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kind of like they always have. You'll give your 510K number. You'll get your 

PMA number. You'll get your acknowledgement letters but you're also now 

going to get a separate email with a separate tracking number and that will be 

your CR number. So you'll get separate letters for each of those. It's important 

to recognize that you - if you're submitting your 510K you don't have to 

request this number. You don't have to do anything. FDA is doing it all and 

you're just going to get the two numbers. So it's like you're getting a two-for.

If categorization is not needed, so there are some applications that we don't do 

categorizations for, calibrated some controls or and certainly if we don’t clear 

you we're not going to categorize you. You'll just receive an email closing out 

the CLIA record which we created saying that we're not categorizing this 

product that you submitted under that 510K. If it is needed you'll receive a 

letter again by email within days of the marketing decision.

So if we clear your products or we give you your SEE letter then 10 days -

within the next 10 days you should also be getting your CLIA categorization.

And of course the CLIA categorization will show up in the CLIA database 

which is the public database and in that database it will also show what your -

what the parent was. So it will associate that 510K, PMA, HTAO, whatever it 

is with that particular CLIA record.

So hopefully all of this will be automated - by automated email. So it should 

be very important that you have correct email addresses and all of your 

submissions to EA. So same thing for if - a little bit different procedure. So if 

you're actually - you're submitting an application to CBER or to Biological 

510K or a BP or you get a - or it's a BLA you'll CBER will do their review 

and when they finish their review if they come out with a positive marketing 

decision then they're going to send that - automatically forward that 

information to CDRH and we're going to categorize and we will issue you a 
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CR number for that. Again nothing for industry to do here. CBER is going to 

do this. Only thing for you to do is be aware that this is what is happening and 

if you don't get a CR number from us after your BK is cleared or your BLA is 

approved. If you don't get that then you should - you send FDA an email 

asking why you didn't get your CLIA record number.

You know, this is a - this is kind of a new process that we're setting up so we 

don't expect it to be 100% from the get go. So totally understand if 

something's happening that you don't understand just send an email. Ask the 

question. Pick up the phone. Ask the question. Not a problem. So for these 

types of applications that either come from CBER, you know, there's - there 

will probably be a little bit of a time lag but we would get these out within 30 

days. It may be a lot sooner. We'll just have to see how this process goes 

because this is really a new internal process for us. So I think it will probably 

be better than 30 days but we had to start somewhere.

So if your device is exempt, you know, before you got that X number you 

won't get an X number anymore. You're just going to get the CR number. And 

if it - if your CLIA - request for CLIA categorization is complete then you're 

good to go but if you're like missing your package insert, which is what we 

use to categorize (unintelligible). So our categorization just begins. Or if your 

device isn't legally marketed and you'll get correspondence from FDA closing 

the CLIA record file. So we won't be having anything to review but we'll tell 

you why we're closing it and what you need to do.

So otherwise, you know, if your CLIA record is complete and we have 

everything that we need and it's appropriate to do that we'll issue your 

categorization within 30 days of receiving that information from you. Again 

there's no - because your product hopefully is already cleared or approved 

there's no FDA review - part of the review going on. It's just the CLIA 
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categorization. So these are the ones we're talking about, either the exempt 

files or those add to files or things that are - for submissions that are - either 

don't need to be submitted to the FDA or have already been submitted to the 

FDA and cleared.

So again these will all show up in the public database with a CLIA record 

number, a CR number, as well as the 510K or PMA number. So it's very easy 

for everybody to pick out whatever number they want. So because most 

people are used to the 510K - seeing the 510K numbers and the PMA numbers 

in the database, although we don't think we necessarily need them there, we're 

leaving them there because that's what people are used to.

If you want to correspond with FDA related to something that's in the CLIA 

database we would strongly recommend that you correspond with us on - in 

providing us with the CR number or the CW number because that relates to an 

individual - a specific application to FDA whereas if you just gave us a 510K 

or a PMA number that could relate - there could be 100 different 

categorizations that are under - that are related to that specific parent 

document or that specific application.

So it may take us longer to find it. So you'll be much better off if it's 

something that relates to something that's in the CLIA database referring to 

the CR number because it's a much more specific number and we'll be able to 

locate it quickly and we'll be able to provide assistance in a much more rapid 

manner.

So again if your 510K is cleared, your PMA is approved and you're just 

submitting an add to file or an amendment to your PMA those will get CLIA 

record numbers and we'll correspond with you related to that CR number.

Again if your submission is missing the package insert or it's missing 
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information that we need to actually complete the CLIA record we'll let you 

know that and we'll tell you what we need or why we didn't do it. And if it is 

complete you'll just get your categorization letter via email and we'll publish 

that information in the public database.

For CLIA waivers by application again we'll send you an acknowledgement 

letter so that you know that we have it and that we're reviewing it. It's 

basically in our hands. So no black hole for CLIA waivers. If additional 

information is needed you'll hear from us by day 90 either putting the file on 

hold or quite possibly maybe not putting it on hold. But if you submit - if 

FDA does put the submission on hold it's basically treating this the same as 

your FDA documents, your 510K or your PMA. You're submitting the 

additional information to the document control center and they'll log it in as a 

supplement to the CW number.

So within 180 total CA days you're going to receive a decision from FDA. So 

it's going to be granted or denied. This will be by an email. So hopefully with 

all this automation that's coming in with all the new IT systems that we have, 

all of this stuff will be - work out pretty smoothly. If we do grant your waiver 

application again it will show up in the public database with your CW number 

but it will also still have your PMA or 510K number.

So what does it mean for industry when it comes to the new dual 510K or the 

CLIA waiver by application process? Well so if you're doing this dual 

submission type again it's important that you have a pre-submission. If you 

don't have a pre-submission and you ask for the dual we're going to say you 

don't qualify for dual. We're still going to review your 510K. We're still going 

to review your PMA but we're not going to review the CLIA piece until we 

finish the FDA piece.
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So if you have a pre-submission and you submit your application and your 

designating it as a dual submission then we're going to treat it as a single 

submission. It's kind of like - think of it as like the De Novo process. It's a 

whole separate application type. De Novo isn't a 510K. It's a De Novo. Dual 

submission is not a 510K. It's a dual submission. It's a 510K and a CLIA 

waiver. That's an entity in and of itself. So let's think of it as a separate entity 

or separate submission type.

And again these cannot be staged or modular. You can't give us one piece and 

say you'll give us the other piece later during the review process. It's got to all 

be in the application when it comes in the door. And unlike other CLIA 

categorization requests the duals because they're coming in with an FDA 

document must come in as a copy.

So if your application is successful you're going to get - well when you get 

your application you're going to get two acknowledgement letters, one saying 

that we received your CLIA waiver, one that we received your 510K. And but 

even though you'll get the two separate letters we're actually conducting the 

review under one review clock and we're doing just the one review.

Because this is coming in as a 510K we're applying all of our - pretty much all 

of our 510K rules to the application. So if - so we're doing a refuse to accept.

Again if a company - if your submission is rejected you'll submit your 

additional information to document control center. They'll send - and then 

you'll send it into the supplement referencing both the CW and the 510K 

number. The review clock resets to zero and we start. Hopefully we accept the 

510K and the review will start on both the CLIA waiver and the 510K review.

So after the - then the next kind of review milestone is the substandard review.

So we do that by day 90. So by day 90 you'll get an email that either puts the 
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submission on hold asking for additional information. You'll submit that 

information to the document on control center. It'll get logged in with a

supplement number when you do respond and it's going to get a supplement 

number for both the CLIA waiver and the 510K. So within a total of 210 days, 

not 180 but within a total of 210 days you're going to receive one of - there's 

one of two outcomes.

Either you'll get SE and you get your waiver approved or you get NSE and 

your waiver is denied. If it's approved and you're waived and of course that 

information will go in the public database.

So pretty simple, pretty straightforward, important to recognize that you're not 

submitting anything new or different to the FDA. These are all internal 

processing stuff for FDA to create these new tracking numbers so that you can 

- so you can track your CLIA submissions or the CLIA stuff separately from 

the 510K or PMA stuff. Again clearly when you're talking to the FDA about 

FDA work you should be referencing your 510K and PMA numbers. When 

you're talking - when your questions are related specifically to the CLIA work 

or the CLIA categorization you should be referencing your CR or CW 

numbers.

So what does it mean for a lab community or for CMS? So the only real 

impact on them and the only thing that they're going to see is the changes in 

the CLIA - in the public database. So the public database is going to have a 

new tracking number associated with it. So they're going to see the CW or CR 

numbers. They've just go to know that that's an FDA tracking number 

assigned to track FDA work. It doesn't really actually have any impact on the 

labs or CMS but of course being something new they'll be wondering what it 

is. So if you're in a clinical lab or a CMS on the phone it just - it's an FDA 

tracking number or tracking association.
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You don't have to worry about it and please don't worry about it because these 

are tracking systems - this tracking system is going from March 21 forward.

We're not changing or creating CLIA records for all the documents that are in 

the tracking system already. So there will be all that legacy data that won't 

have a CR or a CW number and it has no impact. It doesn’t mean anything. It 

just means we weren't tracking them that way previously. So it should have no 

impact so people should not be worried about seeing this new number.

But what it does do because probably the three questions that we get most 

related to CLIA is I can't find my CLIA record or I can't find my CLIA 

categorization in the public database or my CLIA categorization is not in the 

database. Those are the two biggest questions. This will be able - this will be 

much easier for us to find those records now. But the third largest question is 

actually how do I get my CLIA certificate of waiver. And of course we only 

do the categorizations.

You want a certificate of waiver for your laboratory then you still go to CMS 

and they've got a great Web site with all that information on there. So if you 

need your COW or a certificate of waiver you go to CMS for that. FDA just 

does the CLIA categorizations. So we just say whether it's high, moderate or 

waived. That's all FDA does.

So here are your references for information from FDA. That's all the 

information that pretty much we would have as public related to CLIA.

Probably should have put up here CMS's Web site because they own the 

CLIA program and they do a really good job with it. Well any questions 

outside of CLIA categorization should be going to CMS.
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Thank you for participating in this Web site - in this webinar. If you have 

questions at any time - if you don't get to ask them today or we don't get to 

answer them today we have set up an email that is going to be - that's 

monitored by multiple people in my office. So that's the CDRH CLIA 

coordinator. So any questions that you have you can just send to this email 

address and somebody will get back to you.

So hopefully that will reduce some of the anxiety. Any time FDA makes 

changes it causes some anxiety. This shouldn't cause anxiety. FDA is pretty 

much doing all of the work. And some questions and the issues that you have 

when you ask FDA questions you'll have a better way to better identify what 

you're asking your question on so FDA will be able to provide that help more 

rapidly. Thank you very much.

Heather Howell: Okay we'll take questions from anybody on the webinar at this time. Please 

indicate that you have a question and the operator will indicate that it is your 

turn to ask the question.

Coordinator: And to open questions on your phone please dial star one. To ask a question 

record your name. Thank you. I'm not showing any questions queuing up on 

the phone currently.

Don St. Pierre: Wow. Love it. Everyone wants to get home. Okay.

Heather Howell: Okay well this is Heather Howell again and I thank you for your questions or 

actually that was a written script so there was no questions today. Please as 

Don indicated let us know if you have questions in the future at the email 

addresses indicated on your screen right now.

Coordinator: Excuse me Ms. (Howell). Three questions just popped in.
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Heather Howell: Oh wonderful.

Don St. Pierre: Too late...

Coordinator: So the first question is from (Susan). Ma'am your line is open.

(Susan): Yes I just wanted clarification. On the dual review you said that there were 

two options, an SEN waiver or an NSEN waiver denied. Is there also the 

option of an SE with the waiver denied?

Don St. Pierre: No that was not the way that it was intended to happen but probably - I would 

say FDA being who we are we probably would not withhold an SE 

determination if the product was SE. So we probably wouldn't do that but, you 

know, I think that's - whether it ends up for (unintelligible) method it would 

end up taking a lot longer to get that SE decision in the end. So it's probably 

not a good, you know, it's probably not good to think well I'll do them both 

and if I only get one then at least I'm getting one. It's going to take you a lot 

longer to get the one. So I think you should use the dual program.

Again if you need that waiver to actually make your product viable I think 

that's - that was what the intent was for that. I think if you use it for something 

other than that or something more than that I think, you know, it's probably 

going to be disappointing because it is - it's not an easy thing to do. So we'll 

help you out with it as much as possible but the likelihood of success for that 

is clearly not as good as if you just submitted a 510K or a waiver application 

separately so.

(Susan): Understood. I just would hate to start the new - the 510K if we had made it 

that far and lose...
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Don St. Pierre: Yes we wouldn't do it to you. We might want tot but we wouldn't do it to you.

I can't imagine.

(Susan): And then on...

Don St. Pierre: You've got the statutory criteria so I don't think legally we would be able to 

not SE you.

(Susan): All right. And then on the additional information if that's required that follows 

the same time for response, the 180 days, as it is for a 510K?

Don St. Pierre: Yes.

(Susan): All right. Thank you.

Coordinator: And our next question comes from (Kuann Kim). Ma'am your line is open.

(Kuann Kim): Hi. My question is for dual submission. The FDA, the bureau would it be the 

same person or different person is assigned for CLIA waiver and 510K?

Don St. Pierre: No there would be the - it would be the same person but they might set up 

different teams to do different aspects of the review. But it would be - you'd 

be interacting, you know, unless there was a huge workload issue and it could 

be handled more efficiently a different way I would say 99 times out of a 100 

it's going to be the exact same person doing both.

(Kuann Kim): Thank you.
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Coordinator: And the next question comes from (Marlene Hannah). Ma'am your line is 

open.

(Marlene Hannah): Thank you. If a manufacturer has a product that's categorized and in the 

database but we no longer support that product do we need to send in a 

request to have that removed from the database?

Don St. Pierre: You don't have to send in a request. If you do send in a request I'm not sure 

that we would update the database. That might be a good - I mean not helpful 

to have outdated information in a public database but I'm not sure there's a 

way to actually update that database appropriately. One, we'd have to validate 

and make sure that you're actually the person that actually has that submission 

now or has responsibility for that submission.

CLIA wouldn't want companies sending in stuff deleting other people's 

submissions. So there's probably a lot of validation that would go along with 

doing that. But if you send your, you know, that question to the CDRH CLIA 

coordinator email we can look into that more specifically. But to my 

knowledge I don’t think that we update that database to remove stuff that is 

not - that companies are no longer marketing. I know we don't do that for the 

510K database or whatever. So I don't think we would do that either for this 

public database.

(Marlene Hannah): Thank you...

Don St. Pierre: Not that it wouldn’t be a good thing to do.

(Marlene Hannah): Okay thank you.

Coordinator: The next question comes from (Katira). Ma'am your line is open.
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(Katira Kayayha): Hi yes. This is (Katira Kayayha). Thank you Don for an excellent overview 

and on the program. Unlimited commitments have been associated with it and 

particularly with the dual program. I just wanted - I had two questions. The 

first is related to as a company goes through the pre-submission process, puts 

together that submission my understanding is that that option under unlimited 

commitment is available to all manufacturers, that the guidance will be 

provided to the company.

But I just wanted to clarify that that option for dual submission going through 

that process allows a company that option. You talked about success and that 

it can be challenging but I just wanted to clarify that that is an option to 

companies.

And my second because I think that's vitally important we talked about a 

small subset of products. I think in many cases in this particular areas that 

companies simply are - the CLIA waiver is so critically important to the 

submission that as you mentioned the whole intention towards bringing the 

product is for the ability to have a CLIA waiver. So I think that dual program 

is so important, so having that option be available.

And the second is will - I know this was issued just a couple days ago that 

would the agency be open to additional comments around the administrative 

process. You detailed a lot of I think very helpful information and whether 

FDA's open to some - to additional comments on how to support that process 

really and some of the details that you've talked about today under the 

commitment so.

Don St. Pierre: Yes well of course FDA always accepts feedback. So we don't pretend to get 

everything 100% right all the time. Well I may but my colleagues don't. So 
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yes if people have comments on the guidance or something could be clearer or 

it's not understandable or maybe we got something wrong. I don’t think so 

because it follows our internal processes and that's what this was about. But if 

there are - yes if there's issues or questions or certainly if we can present 

things clearer that would be helpful information to have.

(Katira Kayayha): All right. And on the other one in terms of the company going through that 

that the option is always retained for a dual submission understanding though 

that it can be challenging that process and companies and maybe in your 

experience but well my end here they're very cognizant that the requirements 

are distinct but really trying to support the efficiency in the process so.

Don St. Pierre: Yes well eventually - I mean if it ends up - if we end up being able to create a 

dual submission that everything is done with one study rather than separate 

studies for FDA versus CLIA waiver that would be the ideal to do that. So I 

think there is lots of merit to trying this and seeing where we can get but I 

think it's going to be some - yes there will be trial and error and I think it's so 

far companies have found it very difficult and so I think that's why the presubmission is really important so that we can help out as much as we can.

You guys don't have a lot of - industry doesn't have a lot of experience with it 

and neither do we. So working through those problems and issues together is 

probably - if we expect those to become a bigger part of the program then 

we'll need those interactions up front.

(Katira Kayayha): Thank you.

Coordinator: And the next question comes from (Jan). Sir your line is open.
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(Jan): Hi Don. Quick question. The previous version of the CLIA administrative 

guidance had a table that showed needed content for categorization requests 

for various situations, things such as say an exam or a test system for 

replacement reagent. And it looks like the current version eliminated that 

table. I think all it says is just include the labeling. Should a sponsor follow 

what had previously been in there as for content in the earlier version or just 

include an insert?

Don St. Pierre: So I mean when we do our categorizations we base the categorizations on the 

pack insert. So that's how we get our number system. What was it, the table?

(Jan): Yes the table in the former version says for example like for the replacement 

reagent policy anything being submitted should have a package insert that's 

identified for CLIA categorization and reference the original 510K number 

including classification regulation numbers, classification product codes, 

etcetera. It's specific information and it looks like the new version just says, 

you know, or requests including the labeling. So that's why we were 

wondering is if all that information should still be included in the request, the 

specifics.

Don St. Pierre: I may have to get back to you on that. I don't think taking that table out meant 

to change the - anything in the guidance document.

(Jan): Okay.

Don St. Pierre: I think it was just we were trying to make it simpler.

(Jan): Okay.
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Don St. Pierre: And a lot of the things with the replacement we - the replacement of the agent 

when people use that that's where a lot of the issue of making multiple 

changes to multiple products which is why we now use that Excel spreadsheet 

to make those types of changes. So because a lot of those changes happen 

through the replacement reagent policy and so we don't actually see a lot of 

those changes and things. So I think we may have just moved over from what 

was presented there to having this spreadsheet. But I'm not sure that that's the 

complete answer to your question.

(Jan): Okay.

Don St. Pierre: The stuff you've submitted before if you submitted - we're not trying to 

change any of those requirements. So if you submitted it before and you 

submit it now you should be okay.

(Jan): Okay.

Don St. Pierre: Most of what we were talking about today is the different processes that we're 

using internally and what you can see from us. It's not - we're not intending 

people to actually do anything different.

(Jan): Thank you very much.

Coordinator: And the last question comes from (Ms. Kim). Ma'am your line is open.

(Ms. Kim): Okay we're starting to do pre-IDE last year for the opportunity of apply for 

CLIA waiver and then in the middle of time of FDA's review FDA system has 

been changed as a pre-submission. So in the middle of the review we received 

the Q number, the submission number. So this - we can use that pre-
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submission for the apply of dual submission here because we did the presubmission last year?

Don St. Pierre: Well it's not - I'm not clear whether your pre-submission is just for the CLIA 

waiver. So if your pre-submission was for a CLIA waiver and then we 

changed our system and we had provided Q numbers for those presubmissions instead of I numbers then that has no impact. So your CLIA - that 

information is all still relevant. It's just a changing tracking system. You don't 

have to do anything new or different. If you're saying that that pre-submission 

was intended for a dual 510K and CLIA waiver application submission it -

was that what it was for? Or just for the waiver studies?

(Ms. Kim): That is for both, for 510K and the CLIA waiver.

Don St. Pierre: So if it was ended - if you didn't - so I would just - well if I were you I'd cover 

my bases. I would make - I would send an email to the reviewer and say, you 

know, just want to confirm that that pre-submission is my pre-submission for 

my future dual submission so that they know.

(Ms. Kim): During the review process there was a conversation with the FDA and then 

FDA told us, you know, do the 510K first and then go into the CLIA waiver at 

the time.

Don St. Pierre: So well if that's not what you wanted - that's what most people do do. So 

people get their FDA decision so that their product is legally marketed and 

then they - then we do the CLIA piece because that - the FDA has to do CLIA 

based on legally marketed products. The only time that we don't do that now 

is with this dual submission. So if you identified your product as a dual 

submission and you told FDA that you were going to come in with a 510K 

and a CLIA waiver at the same time if they could provide you advice to say 
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probably not a good idea with what you're doing based on the information that 

you've submitted. You'd be better off doing this other way. So they could 

provide that as advice to you based on what you've submitted to them but if 

that's not the advice you want you just say no I want to do the dual 

submission. So I want you to review it in the context of that dual submission.

So and FDA will do that.

The only time FDA will give you the other advice is if they think wow it's 

really based on what I'm seeing they're not going to be successful. So they 

might give you other advice to at least try to help you be successful at least on 

the FDA part and then work separately on the CLIA part. So they could do 

that because they're looking out, you know, based on what you've submitted.

Whether you - because again some people submit their applications thinking 

that their SE studies will cover their CLIA, you know, CLIA waiver and that's 

just not the case.

There are two different statutory requirements that companies have to meet.

So if a company did not understand the nuances of those two programs and 

said I want to do the dual well everybody would say they want to do a dual 

because it sounds better. I can get two answers for the price of one. Well it 

may sound good but you - but it's so much more work than doing, you know, 

one, you know, getting your FDA decision because, you know, FDA threshold 

is a lot lower. It's a lot less burdensome then your CLIA threshold. So it's 

much easier to get a substantial equivalence determination than it is to get a 

CLIA waiver decision based on the statutory criteria.

So it really kind of - I mean I would say I don't think their advice - if I were 

you I would go back to them to try to understand what their advice was 

because you have every right to do - to request a dual submission and they can 

- they should be reviewing it in that context. Again the only reason they would 
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try to steer you away from it is if they really think that you're so far away 

you're going to end up getting neither. So but their job is actually to try to help 

you as best as they can to make it successful.

(Ms. Kim): Okay thank you.

Don St. Pierre: Okay.

Coordinator: And there are no more questions holding on the phone.

Don St. Pierre: So we did have somebody look up that table question. So I'm going to come 

back to the previous question about the table from the guidance.

Woman: Hi yes I found the old version of the guidance and the table you were 

referencing and most of the things outlined in that table call for additional 

copies of the package insert. This was prior to us having e-copies for 510Ks 

and PMAs and so we needed an extra copy of the package insert for us to use 

for the CLIA categorization process. We no longer need that extra copy 

because 510Ks and PMAs and any marketing submission has an e-copy. So 

we're just going to use that same e-copy that we reviewed for the 510K or 

whatever. We're going to use that to do our CLIA categorization piece.

And the replacement reagent example falls under the case where you would be 

asking for a new categorization letter based on additional - based on a change 

to your existing labeling and that's where you would send in the new labeling 

and request CLIA categorization in that submission.

Don St. Pierre: So hopefully that answers the question so it's - I think we're good.
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Heather Howell: Okay. Now again I thank you for your questions today. Please remember that 

this presentation will be available on the CDRH learn section of FDA.gov.

The written transcript will take a couple days but it should be posted no later 

than Friday, March 21. If you have further questions please use the contact 

information provided at the end of this slide presentation. And as always we 

appreciate your feedback on today's presentation and on CDRH learn in 

general. Thank you for participating and this concludes today's webinar.

Coordinator: Your conference call has ended and you may disconnect at this time. Again 

you may disconnect. Your conference call has ended.

END