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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

April 7, 2021

12:15 pm ET

Coordinator: Welcome and thank you for standing by. Today's call is being recorded. If 

you have any objections, you may disconnect at this time. All participants are 

currently in a listen-only mode until the question-and-answer session of 

today's call. I would now like to turn the call over to our host today and that's 

going to be Irene Aihie. Thank you. You may begin.

Irene Aihie: Thank you. Hello, I'm Irene Aihie of CDRH's Office of Communication and 

Education. Welcome to the FDA's 50th in a series of virtual town hall 

meetings to help answer technical questions about the development and 

validation of tests for SARS-CoV-2 during the public health emergency.

Today, Toby Lowe, Associate Director of the Office of In-vitro Diagnostics 

and Radiological Health and Dr. Kristian Roth both from CDRH will provide 

a brief update. Following opening remarks, with will open the line for your 

questions related to the development and validation of tests for SARS-CoV-2. 

Please remember that during this town hall, we are not able to respond to 

questions about specific submissions that might be under review.

Now I give you Toby.
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Toby Lowe: Thanks, Irene. Fifty town halls that was a milestone I didn't know I was 

trying to hit. So seriously though, the FDA has found this to be very helpful

as a way to engage with stakeholders and hopefully you all have also found 

this to be very helpful. So thank you again for joining us this week and for the 

past 50 weeks for many of you.

So, I have a couple of updates today and then we'll go through the questions 

that were sent ahead of time and then open the lineup for live Q&A. So, last 

week right after last week's town hall, we issued EUAs for five serial antigen 

tests. I guess it was UA3 test one of them in a few different configurations, 

but five EUAs. We've issued another serial screening antigen EUA, I believe, 

the day after. And since then we have also issued one serial screening 

molecular test EUA.

So, those are all based on the serial screening supplemental template that we 

issued a couple weeks ago that we talked about on this call. And we're pretty 

excited that developers have been picking that up and we've been able to get 

several authorizations out under that approach and we know that there are 

other developers that are pursuing that and we look forward to keeping the 

momentum going there. We think this will be very helpful for the serial 

screening program that we know are being stood up around the country.

We also since the last town hall issued an EUA for the first antibody test that 

can be used with home collected specimens. So that test can be used with 

(unintelligible) blood spot samples and since two allowed for processing. And 

then just this week our COVID testing basic front page was updated. So that's 

available on the FDA website and provides a lot of good background

information on Coronavirus testing and the different types of tests, when to 

get a test, things like that. 
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Probably all things that the developers who are our typical audience on this 

call already know, but it's a good page to share with folks who may be 

interested in that information.

So with those updated, I will move onto the questions that we got by email. 

Since started out, we got a couple of questions about validation studies for 

multi-analyte molecular tests looking at coronavirus as well as flu, RSV, et 

cetera. And the concern with acquiring archived influenza specimens

particularly is one of the questions that we got. And asking whether FDA 

would consider the use of contrived influenza specimens for an EUA 

submission with the expectation that a perspective clinical study would be 

conducted post-authorization.

We do know that there's been some concerns with the ability to obtain 

archived specimens. And if you are, you know, running into that roadblock, 

we encourage you to reach out to us to discuss your specific situations. But 

for the most part, we do continue to recommend the use of archived positive 

and negative clinical specimens rather than contrived.

We know that, you know, they may be difficult to obtain, but that perspective 

testing is going to be with those, with actual clinical specimens is going to be 

generally what we expect for those types of studies. We have another similar 

question about studies for the same type of tests and also getting into studies 

that would support a potential 510K. We do generally recommend that you 

evaluate clinical performance of those multi NI tests with a perspective 

clinical study. 
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And for EUA, we have indicated that a single site using archived specimens 

would be sufficient and you may want to consider concerning the sample 

positivity due to possible degradation over time. 

There was also a question in that same one about specimen types and whether 

it was okay to use a single swab to obtain an OP sample and then also an NT 

sample so that the specimens tested would be OP/NT. And actually whether 

that would be acceptable for a 510K submission. So we do accept specimens 

that are a mixture of a sample that are (unintelligible) specimens, but if you're 

seeking an upper respiratory claim for individual specimen types, we do 

recommend that each specimen is individually correct and we generally 

consider NP swabs, the pharyngeal swabs to be most challenging upper 

respiratory matric.

Kris, do you have anything to add on those questions about molecular analyte 

tests?

Dr. Kris Roth: Sure, I would say there's a long documented regulatory history for flu and 

RSV and those types of panels and there's numerous deficient summaries that 

are publicly available for analytes that are not in the SARS-CoV-2 and there's 

a lot of information there and a lot of questions can be answered by previous 

decisions on this.

Toby Lowe: Thanks, Kris. That's a really good point that all of that information is 

available on our website and it's very helpful for the test developer.

So moving along, we have a couple of questions about the biospire de novo. 

We do have a question about whether the decision summary for the biospire 

will be posted and it will be. We unfortunately are not able to comment on 

the timeline. We are working on getting that out. I'm sure everyone is aware 
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that decision summaries for de novo sometimes takes some time to get posted. 

But we are working to expedite that one.

We also briefly discussed just a little bit last week but there's a question about 

the biospire being challenging to have access to as a predicate since it's the 

only de novo currently in the - the only predicate for a future 510K for a 

SARS-CoV-2 test. And we did talk last week that you can use an EUA 

authorized test as a comparator for your clinical studies even though biospire 

would e your predicate for the submission itself.

The question also was asking about whether there are other options such as 

testing to the reference panel to support a 510K. And while we do consider

another EUA authorized comparator to the acceptable we do really want to see 

the perspective clinical study in your 510K submission. You can also include 

reference panel results and the clinicals that are from your authorized EUA if 

you have one and leverage those but they would not be, generally they would 

not be considered to be sufficient on their own to support a 510K clearance.

Kris, anything to add on that one?

Dr. Kris Roth: Sure, I think, you know, in this time between while we're waiting for that 

decision to maybe be posted, you know, the granting letter is posted and it 

does have the special controls noted for these types of tests and you can take a 

look at those special controls and design your studies to mee those 

requirements as well.

Toby Lowe: Great, thanks. So moving on, we have some questions about asymptomatic 

screening. And particularly related to the supplemental template that we put 

out and asking about the post-authorization validation studies. Generally we 

would want to see your proposal for a serial testing plan and the post-
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authorization study in your EUA request. And we would discuss that with 

you during the review particularly the statistical plan which is what this 

question is focused on. We would want to go through that with you in detail. 

So we can't really get into too many details on the specific book on this call 

because it will be specific to each individual test and each approach that 

you're looking to take as a test developer to validate your test.

And then along the same lines with serial screening using that supplemental 

template, we have some questions about the additional data that we would 

expect to see. And so, you know, the way that supplemental template is laid 

out is that it is there as an approach sot that if you have symptomatic 

validation data and you've been authorized for testing symptomatic 

individuals, that template allows you to expand your or to request expanding 

your claims to asymptomatic serial screening without doing that additional 

asymptomatic validation ahead of time. That would be the post-authorization 

condition.

So generally, you know, for most cases as long as nothing else is changing, so 

you're not changing your patient population such as point of care to at home 

or other changes that might impact the usability. We would not expect to see 

additional validation clinical or usability as long as nothing is changing except 

for going from symptomatic to serial screening. And we could discuss that on 

a case-by-case basis if there are things that are changing whether there is 

additional data that we would need to see.

And then there is another question along the same lines asking about 

removing the prescription requirement when going from prescription to overthe-counter. We do have recommendations in the template for OTC use that's 

in the nonlaboratory use template for molecular and antigen tests. The 

supplemental template that we've been talking about also can support this 
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move from prescription to over-the-counter because one of the requirements 

for over-the-counter is that there is an asymptomatic claim.

We generally would not authorize a test for over-the-counter use if it does not 

have that broad asymptomatic screening claim since that's how we would 

expect it to be used over the counter. And so if you are able to use the 

supplemental template to get that asymptomatic claim, as long as everything 

else about your test is appropriate for over-the-counter use and has appropriate 

labeling, usability user comprehension for a lay user then we would be able to 

do that over-the-counter labeling for you as well in that same EUA request.

All right, we have a question about developing a point of care molecular 

diagnostic leader and (unintelligible) system and what the recommendations 

are for sensitivity specificity and validation testing. Also for (unintelligible) 

testing in that situation, so pooled sample collection. So we do include 

validation recommendations in the molecular diagnostic template for point of 

care testing and for pooling. We have not as of yet authorized any tests for 

pooling at the point of care and so we would want to have some further 

discussions about that and how you intend to implement that. So tat we can 

make sure that it is a plan that is appropriate for a point of care setting.

But generally, we would encourage you to take a look at the template to look 

at the validation recommendations that we have there for the number of 

specimens and the validation approach and if you have alternative validation 

methods that you'd like to discuss you can reach out through a EUA to discuss 

those.

And that question was also asking about whether pooled testing is considered 

a diagnostic or a screening. And I do want to clarify that we, you know, we 

have talked a lot about diagnostic testing and screening testing. And we talk 
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about screening when we're talking about testing asymptomatic individuals 

that have no reason to suspect that they have COVID-19 and doing that broad 

screening to capture those asymptomatic individuals.

But really a screening test is a subset of a diagnostic test. It is looking to get 

an individual result and to identify individuals who have SARS-CoV-2 

present and has that, had COVID-19. So it is considered to be a diagnostic 

test from a regulatory perspective. We just generally refer to it as screening to 

be clear about the implication that we're talking about with the patient 

population.

And Kris, did you want to add anything there about this question about point 

of care testing or pooled testing?

Dr. Kris Roth: No, it's just that I think you stated it correctly. Our, you know, we have an 

open approach. We haven't kind of done it yet, but that's something to work 

on the future, thanks.

Toby Lowe: Great, thanks. We have a question about how presumptive positive results 

should be treated in calculating the NPRA, NPPRA and a clinical study and 

whether they should be treated as positive or inconclusive. Generally we 

would recommend, I think this question is talking about the results for the 

comparator test. So generally we would recommend that you follow the result 

interpretation of the test that you're using as the comparator. So the EUA 

authorization for the comparator test should have a result interpretation

section that indicates how those results would be considered.

And I think in the, Kris, you might want to touch on how we have those 

(unintelligible) table. I think we do include presumptive positives as positives

in the 2x2 table for calculation for PPA. Is that right?
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Dr. Kris Roth: Correct, yes.

Toby Lowe: Great. Okay, the next question is asking about over-the-counter corrections 

with testing in a lab for PCR testing. So this would be nonprescription, direct 

to consumer home collection and whether asking about what template to use. 

So we do have nonprescription direct to consumer home collection tests that 

we have authorized. And the authorization documents on our website would 

be a great starting point for looking at how those were laid out and what we 

looked at. 

And the question is also asking about whether they can use a hybrid of the 

over-the-counter home collection kit and molecular PCR templates. And that 

is absolutely a good way to go. Those templates are on it to be complementary

since there are situations such as this one where pieces from each of them 

would be appliable and we would suggest that you do pull the parts that are 

applicable from each of those and include them in your EUA request when 

you submit them.

So question is also asking whether the new supplemental template for a serial 

screening test can be used. And yes it also can be used in that situation.

And asking about how many participants are required for an over-the-counter 

usability validation. There is a usability study recommendation in the nonlab 

template but that really is focused on testing that are completed - that are 

performed completely outside of a lab. Those fully at home tests and that 

recommends, I believe, 100 participants for OTC use. For home collection, 

you can take a look at the home collection template which I believe is 

recommending for e-Participants. If you have further questions about your 

specific situation, please reach out.
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And I believe that is all of the questions that we've prepared ahead of time. 

And so we can open things up to live questions now.

Coordinator: If you would like to ask a question at this time, you may press Star 1. Again to 

ask a question at this time, press Star 1. Our first question will come from 

(Shannon Sharp). Your line's now open.

(Shannon Sharp): Good morning, this is (Shannon Sharp) with user-wide consulting. So I have 

a very specific question about the human factor validations testing or usability 

study for OTC. So historically when we're performing human factors 

validation testing we performed self-selection test cases to demonstrate that 

layperson understand the outer packaging and aren't purchasing the kit when 

they shouldn't. Do they understand that the product should not be used for 

children below two years of age?

So does the agency expect that we run this test case for all users in the study, 

all 150 participants? That is 50 participants, 50 teams including users who 

don't typically need this information? Because we're actually finding in our 

studies that adolescents who typically are not shopping for one-year-olds they 

generally are unsuccessful with this test case because they don't have a 

representative level of motivation or attention similar to what you'd see with 

parent participants or adults.

So in summary, does the FDA expect that we perform self-selection testing in 

general? First question and then second, can we proceed with not testing 

adolescents for test cases that they would very rarely perform?

Toby Lowe: That's for that question. So, you know, with are interested in user 

comprehension and making sure that the packaging is understandable for a lay 
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users. I think we are open to approaches that are reasonable in the emergency 

setting. And if you have a particular proposal for, you know, what you think 

is reasonable based on the labeling that you have, we would be open to 

discussions about that and considering the approaches that you are proposing.

I think if you have historical information showing that teenagers typically

don't understand this, but also don't need, that's something that you could 

include in your submission. I think that would be a very good conversation to 

have in a pre-EUA specific to your situation so that we can consider the plan 

that you in place.

(Shannon Sharp): Excellent, thanks so much.

Coordinator: Our next question will come from (Stan Tally). Your line is no open. (Stan), 

please check your line. Your line is open. Okay, our next question will come 

from (Ray Vanzulas). Your line is now open.

(Ray Vanzulas): Hello, thank you for taking the question and thank you for continuing this 

series. My question is first some context, my company is developing devices, 

molecular devices for COVID testing that speak to increasing scale capacity 

of VGR tests in a 24-hour period and a variety of solutions are in 

development.

The specific question I had related to that is whether FDA would be open to 

consideration in either a resubmission or perhaps other kinds of discussion to 

consider clinical performance data that was generated outside of the US. 

Specifically we have a device combination that's been in use under the CEIBD 

mark in the UK since December. And significant clinical data is being 

generated and is now sitting with a peer-review publication. 
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And we would like to have an opportunity to discuss those results and an 

opportunity to perhaps discuss an efficient path to authorization for a similar 

device combination in the United States. Thank you.

Toby Lowe: Great yes, so we have accepted data from outside of the US for clinical 

studies. We generally for point of care want those studies to be done in the 

US because we have found some issues with making sure that point of care 

studies done outside the US are truly applicable to a US setting. So in that 

case we would want to see them done here, but for central lab tests, we would 

definitely be able to considering data from outside the US and we would be 

interested in talking to about that approach and how, you know, how it is 

applicable to a US population.

You may also want to consider including in your submission some 

information on the prevalence rates in different, you know, where it was 

studied as well as the circulating variants. Because we may want to see how 

the different variants are addressed if there are different variants circulating in 

the place where the study was performed versus here in the US. Kris, do you 

have anything to add there?

Man: No, it's an interesting question especially, you know, the variants aspect of it. 

You know, as we see more and more genetic variants emerge, you know, this 

question may become more applicable going forward.

(Ray Vanzulas): Yes, so just in terms of logistics, would it be best to put all of that together in 

a presubmission format and then request a teleconference discussion on it?

Toby Lowe: I think that you could include it all in your submission. Kris, did you want to 

see a presub for that or just include it in an EUA request and we could discuss 

any issues after further review?
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Dr. Kris Roth: I think at this point we prefer to see the EUA request and if you have existing 

data, you know, that would be helpful to take a look at as well.

(Ray Vanzulas): Okay, very good, so straight to the request. Thank you very much.

Coordinator: Our next question will come from (Susan Sharp). Your line is now open.

(Susan Sharp): Hi, thanks Toby. Quick question, if you're looking to add swab pooling to an 

existing EUA, can this be done a supplemental submission for the existing 

EUA and which, you can use the molecular pooling template for the swab 

pooling as well. Is that correct?

Toby Lowe: Correct, yes. If there's an existing EUA and you want to add swab pooling 

that definitely can be done through a supplemental EUA request using the 

name after a template with the pooling information in there. And if you have, 

you know, alternate approaches to validation that you're looking to consider, 

you can reach out with those as well.

(Susan Sharp): Thank you.

Coordinator: Our next question will come from (Annie Bright). You line is now open.

(Annie Bright): Hello, thank you for taking my call, we had a question for antigen tests the 

have been recently approved and we've heard they all have mobile apps and 

that the mobile appreciate would be required four months after EUA 

approval's been achieved. Is this correct? And also, we wanted to confirm the 

requirement for the mobile app which is just to basically ensure that the 

individual would be able to send the data to their physician. Are there any 

other requirements for the appreciate?
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Toby Lowe: So the appreciate is something that we've included as a post-authorization 

condition for some of - for tests that did not have reporting capabilities 

generally. So this is, for the most part, related to having the ability to report 

results to public health authority. So for laboratories there is a requirement for 

labs to report results to public health authorities, that requirement does not 

exist for home tests. But obviously reporting to public health authorities is 

very important for monitoring the pandemic.

So the mobile app is one way to enable that reporting from a home test to the 

public health authorities. So that's something that we have not required 

preauthorization as an authorization requirement for these at-home tests but 

we have worked with the developers to put a plan into place to get those, to 

get that reporting capability worked out within an agreed upon time frame 

after authorization. And I believe that's what you're referring to with those

mobile apps.

(Annie Bright): Yes, and then basically because you know, we currently are a company that 

currently doesn't have any you know, software engineering, anything like that. 

So we would be, you know, trying to work with a company. So we're trying 

to figure out like which other requirements would we have to look at for the 

appreciate. So that's mainly reporting, right? If one capability and sending the 

data to the physician or directly to the state?

Toby Lowe: So reporting to the public health authorities, I believe is what we're generally 

focused on there although reporting, you know, the ability for an individual to 

report to their personal provider is also beneficial. But the public health 

reporting is really the focus of those post-authorization conditions. And the 

requirement for those are something that we can work with you on during the 

review. It's not something that you necessarily have to have fully worked out 
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before you come in. You know, we really want to get tests out, get good tests 

authorized as quicky as possible and that's one of the reasons that this is, you 

know, being added as a post-authorization condition rather than something 

that we're requiring upfront because we don't want that to hold up the 

authorization.

(Annie Bright): So, we wouldn't have to worry about incorporating it into our clinical studies 

or our usability studies.

Toby Lowe: We would discuss with you during your EUA whether there would be a need 

for additional usability post-authorization for that.

(Annie Bright): Okay, I see.

Toby Lowe: As long as it's not needed to perform the test in your initial authorization, we 

wouldn't expect to see usability with it at that stage.

(Annie Bright): Okay, I have one more question. So regarding stability testing, stability

studies for home use and also for professional use, is the expectation that the 

testing should be done in the United States or can we do it outside of the 

United States if you were having issues with like customers and everything if 

it's manufactured in China?

Toby Lowe: You said this is for stability studies? 

((Crosstalk))

(Annie Bright): No, stability.

Toby Lowe: Okay, so for stability that can be done in a lab. 
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(Annie Bright): Can you - so it doesn't matter where the lab is?

Toby Lowe: Right, that can be outside the US. 

(Annie Bright): Okay.

Toby Lowe: It's just the clinical and the usability that we really want to see in the US or 

point of care tests.

(Annie Bright): All right thank you very much.

Toby Lowe: Sure.

Coordinator: And our next question will come from (Richard Montega). Your line is now 

open.

(Richard Montega): Yes, with will be running a perspective study for an expanded respiratory 

panel. And since we already have an EUA authorized, a Coronavirus test with 

a decent limited detection. We're at 1800 ND per mil. Is there any problem 

with us using our own test as the comparator for the SARS-CoV-2 portion of 

the study?

Toby Lowe: Kris, do you want to talk about this one?

Dr. Kris Roth: Sure, for a 510K study, I think the evidence or the performance evaluation is a 

little bit different than the EUA.

(Richard Montega): Yes, we're assuming we'll be running perspective study for 510K.
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Dr. Kris Roth: Sure for your SARS-CoV-2 analyte and other analytes, is that correct?

(Richard Montega): Correct.

Dr. Kris Roth: So you'd have a comparator method that would cover all of the analytes in 

your study and for SARS-CoV-2, I think we would likely recommend two out 

of three EUA tests. So performing three EUA tests on all samples and if you 

know, two out of three positive defines a positive. It's likely what we would 

recommend for that.

(Richard Montega): Okay, thank you very much.

Toby Lowe: And this is something that, you know, as you are heading toward a 510K that 

we do recommend that you come in with a presubmission rather to discuss 

that study design.

(Richard Montega): Okay, thank you.

Coordinator: Our next question will come from (Susan Sheldon). Your line is now open.

(Susan Sheldon): Hi, thank you Toby and Kris for doing this. I have one question about the 

antigen template. It describes the comparator and when you look at what's 

posted on the webpage, it's difficult to figure out which one meets all those 

conditions. So I did the best I could and came up with clarified COVID-19 

test kits, manufactured by Quadrant. Is that an acceptable comparator for an 

antigen test?

Toby Lowe: Yes, there is a clarify test kid is an appropriate comparator. And we have as 

we've mentioned, I think, on the call before (unintelligible) for others 

awareness. If you do have questions about what is an appropriate comparator 
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or if a specific test that you're looking to use is an appropriate comparator, you 

can send that into the EUA mailbox and we and get back to you on that as 

well through that mailbox.

(Susan Sheldon): I appreciate it, thanks.

Coordinator: Our next question will come from (Mark Delzecco). Your line is now open.

(Mark Delzecco): Good afternoon Kris and Toby. This is Mark. I have an administrative 

question related to the periodic CDRH emails that are put out regarding the 

status of various diagnostic EUAs. They're usually categorized into four 

separate categories. New, which obviously what that is. Reissue, updated and 

revised EUAs and I'm often asked what the differences are between those and 

quite frankly I don't know what they are. So hoping you could describe what 

the differences are between those three categorizations.

Toby Lowe: So I'd have to take a look at the specific email to know exactly which emails 

you're referring to. But generally, you know, new is sort of obviously. 

Reissue is typically when we reissue the complete letter of authorization. 

That's usually done for things like an update to the intended use. You know, 

whether it's going from symptomatic to asymptomatic or adding pooling, 

things like that, that are large changes would be done through a reissuance of 

the letter. 

Updates and revisions, I'll see if Kris might have more on the difference 

between those two, but there are certain changes that we can grant through 

what we refer to as a granting letter. And those are included on the EUA table 

as you look at a specific test. There's often a little plus sign next to the row 

and if you click that some of them will have other documents and those will 

be a letter granting an EUA amendment in many cases.
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And a lot of times those are for smaller changes like an update to the labeling

that would not change the intended use in any way. We also sometimes 

update labeling for things like adding the reference panel results. And so 

those are some of the changes that would get updated on our website, but don't

require a reissuance of the letter of authorization. 

Kris, I don't know if you have any other thoughts on the difference between 

updated and revised.

Dr. Kris Roth: I don't, but I think they generally fall into the category of, you know, the 

letter.

((Crosstalk))

(Mark Delzecco): Sorry. I'm just curious because people ask me that all the time and I don't

know the difference, so but thank you. I appreciate the information.

Toby Lowe: No problem.

Coordinator: Our next question will come from (Sandy (unintelligible) Stevenson). Your 

line is now open.

(Susan Katy Stevenson): Hi, this is (Susan Katy Stevenson). Toby and Kris and all of the 

folks at FDS thank you so much for all the hard work that you're doing. We're 

working with a small company and I think I know the answer to this question, 

but they have specifically asked that we ask the agency the following. 

Whether or not there's an EUA pathway to obtain quote unquote pan EUA 

authorization for a sample home collection device. Where the collection 

device has demonstrated the required performance with an authorized EUA 
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molecular test. And if they wanted to expand it to be used with other EUA 

authorized molecular assays could that be done without additional testing?

Toby Lowe: So, I'm not sure that I fully understand the questions. So let me give a little bit 

of information and ask for a little clarification. So we have issued a couple of 

EUAs for collection devices for molecular testing. Those so far have been for 

saliva. An in that case, those were issued specifically because there was not 

any legally marketed collection devices for the collection of RNA in saliva.

And so those were issued under EUA with fairly general indications for 

molecular testing. And then the assays are, you know, authorized for use with 

saliva using one of those. 

So I'm sure if that's the type of situation that you're referring to or I'm not 

quite sure what you're getting at with a pan SARS-CoV-2 claim for a 

collection device.

(Susan Katy Stevenson): Yeah, I think that you've answered the question.

Toby Lowe: Okay, great and, you know, I don't know if the device that you're referring to 

is for saliva or something else. You know, depending on what it is for and 

whether there is you know, a need for it, from you know, from an emergency 

perspective would be one of the factors that we would look at as to whether or 

not it would be considered for an EUA. You know, for example a lot of 

swabs available and they are 510K exempt generally. So that might be an 

area that we would consider for an EUA depending on the specific situation 

and the specific device.

(Susan Katy Stevenson): It would be for something like a dried blood spot sample collection 

production.
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Toby Lowe: Okay, and I know that for dried blood spot, there are some assay-specific 

issues. So we would have to look at the specific validation and whether there, 

you know, is a broad claim that could be considered or whether it would need 

to be validated specifically with each test. But that's something that we could 

have further conversations about specifically about that.

(Susan Katy Stevenson): Okay, great, thank you.

Toby Lowe: Sure.

Coordinator: And our next question will come from, I believe it recorded their name as 

(Von Say). Their line is now open.

(Von Say): Yeah, hi. Thanks for taking my call. I have a client that's basically 

developing an at-home COVID-19 neutralizing antibody test. And the 

question really relies around the neutralizer comparator method that is 

recommended in the template, the EUA template. Essentially the client is 

asking because of the current methods that are recommended if the plaque 

reduction neutralization test or the focused reduction neutralization testing and 

it requires, you know, cells and virus. Can they use for neutralizing 

comparative methods something that's recently been EUA, the gen script Cpass method?

Toby Lowe: So unfortunately, I am not an expert on the serology tests and don't have 

anyone on from the serology team today. So I don't know that I'm going to 

specifically be able to answer the question. But I think that it's something that 

we would want to discuss in a pre-EUA. But generally, I think that is not a 

comparator that we would think is appropriate. So we would want to have 
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further discussions. Send that into the mailbox and we could get one of the 

SMEs from the serology team to get back to you on that.

(Von Say): Okay, I already did submit that as a question to the IDT team.

Toby Lowe: Okay, great then I'm sure that if they haven't yet, they will get back to you 

shortly on that one.

(Von Say): Okay, super, thank you very much.

Toby Lowe: Sure, sorry I can't give you more on that one, but I know the SMEs will be 

able to.

Coordinator: Next question will come from (Sarah Burlucky). Your line is now open.

(Sarah Burlucky): Hi, on a previous call, you had said that unsupervised self-collection of 

anterior nasal and (unintelligible) swabs in a healthcare facility didn't require 

an FDA authorization. My question is does that also apply to saliva collection 

within a healthcare facility?

Toby Lowe: So within a healthcare facility, for self-collection, unobserved, we do think 

that you should consider the usability and the appropriateness of lay collection 

without observation. And we would expect that to be part of your validation. 

So if that's the intended use that would be how you should validate the test,

But we do not consider that to be equivalent to home collection because it 

does not have the same, you know, some of the same issues in terms of 

(unintelligible) transport and shipping and things like that.
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(Sarah Burlucky): Okay, so that could be applied to any sample types that we appropriately 

validate?

Toby Lowe: That's correct.

(Sarah Burlucky): Thank you.

Coordinator: Our next question will come from (Shannon Clark). Your line is now open. 

(Shannon)?

(Shannon Clark): Hello, this is (Shannon Clark) again, (unintelligible) Consulting. I just had a 

question. If we are planning to get OTC designation but we would like POC 

designation in the meantime, can we complete the clinical evaluation for OTC 

and submit that in lieu of point of care clinical studies with healthcare 

providers? So use lay user data as an input to a point of care only submission 

as we're working to complete that human factors study for OTC?

Toby Lowe: So, let me make sure I got the question right. So you have a test that is 

designed for over-the-counter at home testing but you want to start with point 

of care, is that right?

(Shannon Clark): Yes, so first of all just get that point of care authorization and then three 

months later once the human factor study is done, then we would pursue OTC.

Toby Lowe: So generally, yes, you can. But generally we would prefer that tests that are 

designed for at home use be submitted as that complete submission. You 

know, obviously we have a lot of submissions that we're working through and 

from a resource perspective, it is more beneficial both for, you know, for FDA 

reviewers and for the public health to have those tests available as quickly as 

possible. And so it's a much more streamlined process for us to be able to 
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review the complete dataset and the complete submission all at once and go 

through straight through that so that over-the-counter at home testing

authorization which is really designed for and will be most beneficial in that 

setting.

(Shannon Clark): Okay.

Coordinator: Our next question will come from I believe they recorded their name as 

(Talisha Lee) or either (Alicia Lee). Your line is open.

(Alicia Lee): Hi, thanks for taking my call. I wanted to get clarification on the antigen

template regarding multi-analyte panel. So it's stated that if your device has 

been previously FDA clear for influenza or other respiratory pathogens, you 

should also test at least 10 retrospective positive clinical specimens of each 

previously clear analyte. So our (unintelligible) assay is a POC antigen test. I 

wanted to double check that this requirement can be met with in-house sideby-side analytical testing?

Toby Lowe: So you're looking to do the validation for a previously cleared or basically for 

adding SARS-CoV-2 to a previously cleared point of care antigen test? That 

was previously cleared for flu or other respiratory analytes?

(Alicia Lee): Yes, previously cleared for flu. We're wondering if that particular template 

requirement of testing of at least 10 retrospective positive clinical specimens 

if that is met for analytical testing or is it speaking to a clinical study?

Toby Lowe: That is for analytical.

(Alicia Lee): Okay, and then just to double check, so is there any additional clinical

evaluations required for the previously cleared influenza part of the multi
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analyte panel? Or are we just able to reference previously clarified 510K 

data?

Toby Lowe: So we would want to see those retrospective clinical specimens which we 

talked about, testing in-house. And then you would be able to leverage 

information from your previous clearance.

(Alicia Lee): Okay, thank you very much.

Coordinator: And as a reminder, if you'd like to ask a question, you my press Star 1 and 

record your name clearly for question introduction. Our next question will 

come from (Roxanne Chain). Your line is now open.

(Roxanne Chain): Thank you. Yes, we would like to add saliva as a sample type to our existing 

EUA and understand we need 30 pared saliva and NP in the clinical validation 

study. So my question is for the saliva samples, currently we have a mixture 

of broad saliva as well as saliva collected using an FDA approved device. 

And counting them together we will have more than 30. Is this something 

that's acceptable to the agency? Or we have to have you know, 30 raw saliva 

and 30 saliva collected using an approved device?

Toby Lowe: So first question would be when you say an approved device, do you mean 

one of the, so a collection device that has an EUA authorization?

(Roxanne Chain): Yes, that's correct. I'm sorry, yes EUA.

Toby Lowe: Okay, so we do, you know, we want to see the test validated the way that 

you're intending for it to be used. So if you are intending for the saliva 

specimen to be collected using one of those authorized collection devices, 

then we would want to see the paired specimens in that device. If you're 
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intention is for the test to be used with raw saliva, then we would want to see 

it validated in that way.

(Roxanne Chain): So that means that you would like to see - well our intention really is to 

validate raw saliva. So you would like to have 30 paired raw saliva with NP, 

then?

Toby Lowe: That's correct.

(Roxanne Chain): All right, thank you.

Toby Lowe: Yes, we want the 30 paired to be with the specimen as it would be intended to 

be used.

(Roxanne Chain): Understood, okay thank you. 

Irene Aihie: Thank you, Toby. That will be our last question. I just want to thank 

everyone for participating today. This is Irene Aihie. We appreciate your 

participation and thoughtful questions during today's town hall. Today's 

presentation and transcript will be made available on the CDRH learn 

webpage at www.FDA.gov/training/CDRHlearn by Friday, April 16. If you 

have additional questions about today's presentation, please email CDRHEUA-templates@fda.hhs.gov. 

As we continue to hold these virtual own halls, we would appreciate your 

feedback following the conclusion to today's virtual town hall. Please 

complete a short 13-question survey about your FDA, CDRH virtual town hall 

experience. The survey can be found now on www.fda.gov/cdrhwebinar. 
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Again thank you for participating. And this concludes today's virtual town 

hall.

Coordinator: This concludes today's virtual town hall. You may now disconnect. Thank 

you for your participation on today's call.

END