FDA Townhall

Moderator: Irene Aihie

02-10-21/12:15 pm ET

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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

February 10, 2021

12:15 pm ET 

Coordinator: Welcome and thank you for standing by. At this time, all participants are in a 

listen-only mode until the question-and-answer portion of today’s call. During 

that time, if you would like to ask a question, please press star 1.

Today’s conference is being recorded. If you have any objections, you may 

disconnect at this time. I would now like to turn the meeting over to Irene 

Aihie. You may begin.

Irene Aihie: Thank you. Hello. I am Irene Aihie of CDRH’s Office of Communication and 

Education. Welcome to the FDA’s 42nd 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 Timothy Stenzel, Director of the Office of In 
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Vitro Diagnostics and Radiological Health, both from CDRH, will provide a 

brief update.

Following opening remarks, we 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 are under review.

Now, I give you Toby.

Toby Lowe: Thanks, Irene. Thanks everyone for joining us again today.

First, we have a new funding opportunity to tell you about. There should be a 

slide showing now that has some additional information about this. This is a 

funding opportunity for COVID-19-related diagnostics that opened on 

February 5. 

FDA is not leading this effort, but we wanted to flag it for you. It’s being 

coordinated by HHS OASH, Office of Assistant Secretary for Health, and the 

DoD, and it’s open until March 7. The slide that’s showing now has more 

details, including a link for information and the process for submitting 

proposals. And we will get the slide deck posted on our Website on the Town 

Hall page either later this week or when we post the transcript.

So, this is an Area of Interest, or an AOI, that’s soliciting for proposals where 

you may request investment funding for capacity expansion and provide price 

quotes for raw materials, test components, supplies, et cetera for COVID-19 

point-of-care tests and other IVDs. This is an expedited process that’s 

coordinated by HHS and OASH and DoD to support the government’s 
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COVID-19 response to rapidly increase manufacturing capabilities within the 

diagnostic supply chain.

So, with that, we can go on to the next slide, Irene.

And we’ve added a couple of additional links to this slide as well that we 

think will be helpful resources for you. One of them is the January 2021 HHS 

FAQ on COVID-19 diagnostic data standards and core data elements for test 

reporting.

And then the next one is the HHS COVID-19 testing and diagnostics working 

group additional testing information. So, those links will be up on the slides 

that will get posted as well and may have some helpful information for you.

And then my last update is that we had a question last week about UDI, 

Unique Device Identifiers, and whether UDI is required for EUA devices. 

And generally, for - at least for the diagnostics, UDI has not been included as 

a condition of authorization. So, we would not typically expect a UDI unless it 

is included as a condition of authorization in the letter - the EUA letters.

However, there’s no restriction from providing UDIs, which many 

manufacturers do, and this is really helpful because the device identifier is a 

required data element to fulfill the laboratory reporting requirements listed in 

the HHS COVID-19 laboratory data reporting guidance. So that was just a 

follow-up from last week’s call.

And with that, I think we can turn it over to questions.

Irene Aihie: Operator, we’ll now take questions.
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02-10-21/12:15 pm ET

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Coordinator: Thank you. We will now begin the question-and-answer session. If you would 

like to ask a question, please press star 1. Please unmute your phone and 

record your first and last name clearly when prompted. Your name is required 

to introduce your question. Also, we ask that you limit yourself to one 

question. To withdraw your question, you may press star 2. Once again, at this 

time, if you would like to ask a question, please press star 1.

And our first question is from Christy Bergerson. Your line is open.

Christy Bergerson: Great. It’s Christy Bergerson from Exponent again. I wanted to ask you 

about transferring ownership. So, is there a process for transferring ownership 

of the EUA, such that a new developer would take on the responsibility for 

deployment and liability? And also, when should that happen? Should we wait 

until after authorization, or could it occur at any time?

Timothy Stenzel: If it’s preauthorization, let’s take care of that prior to authorization. If it’s 

post-authorization, just go ahead and contact the Reviewer to review what 

they may have to update. 

Toby, you have anything to add?

Toby Lowe: Yes, I think that’s absolutely correct.

Coordinator: Our next question is from Shannon Clark. Your line is open.

Shannon Clark: Hi, this is Shannon Clark with UserWise Consulting. We specialize in homeuse human factors testing. 

So, if an antigen test kit developer fulfills all requirements for over-thecounter home use noted in the molecular and antigen diagnostic COVID-19 
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tests for non-laboratory use template, including clinical evaluation, and 

basically fill all the requirements there, then will they automatically receive 

authorization for selling to moderate, high, and point-of-care contexts without 

having to do further testing with five-to-six non-laboratorians, like health care 

providers and at least 30 positive samples?

Timothy Stenzel: Yes, it already - automatically gets a deemed waived status, and waived tests 

can be performed in CLIA waived settings as well as moderate- and highcomplexity labs.

Coordinator: Our next question...

Timothy Stenzel: And...

((Crosstalk))

Timothy Stenzel: Okay, go ahead.

Coordinator: Oh, I’m sorry. Our next question is from...

Timothy Stenzel: I think I answered the question. Thanks (over there).

Coordinator: You’re welcome. 

The next question is from (Gary Block). Your line is open.

(Gary Block): Hi, Tim. We are a sample collection device manufacturer, and we want to 

know if we can apply for an EUA making the following claims: We’re not an 

assay developer, so the current templates probably don’t apply to us. But 
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specifically, we wanted to claim for SARS that our sample collection can 

detect SARS. 

The second claim is that we want to make a home collection claim that it’s 

safe to be collected at home. 

The third thing is that our sample collection collects from the area of the nasal 

cavity, the nasal pharynx, and all the pharynx, and the device also 

concentrates it. So, we get a very high level of viral load.

We also wanted to make a claim that our sampling device can be used across 

all platforms - all molecular platforms, molecular point-of-care platforms, and 

over-the-counter molecular or immunoassay platforms. Obviously, we would 

provide data that our sample met the required threshold line.

We don’t necessarily want to be - we don’t necessarily want to partner with 

other assay developers as that would significantly limit out market exposure to 

any specific assay. Thank you.

Timothy Stenzel: Uh-huh. Stay on because there may be some clarifying questions. We 

definitely want Toby’s help on this as well.

So, yes, if you make any claims about SARS, it’s important to get an EUA 

authorization about a device - a collection device. 

And then, of course, the validation that we would ask for could depend on 

whether you’re going for a prescription-use device or an over-the-counter 

device. And so, I’d refer to the templates for home collection for the different 

recommendations for validation of those.
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You know, if you’ve got a device that might increase sensitivity through 

concentration, that’s great. We’ll just, you know, want to make sure that it 

works. 

And then, as far as how broadly you can claim for use with molecular assays, 

you know, I would ask that you come in with a protocol and a pre-EUA with a 

study plan to demonstrate that. 

So, we typically have been authorizing these collection devices in a kit based

on single-test data. We are making it relatively easy for other tests to be 

added. 

But to date, we have been asking for data for the test that it’s going to be used 

with to make sure that it performs well in the marketplace. 

Toby, do you have anything to add?

(Gary Block): I’m sorry?

Toby Lowe: I think that covers everything that I would have - all the points that I was 

planning to make it on. Yes.

Timothy Stenzel: Okay. I wrote it to Toby’s standard. I did well.

(Gary Block): Okay, if I can just add, if we would, for example, demonstrate, you know, our 

platform - so for, let’s say, just as an example, three or four amino assay 

platforms, and three or four point-of-care items assembled, you know, 

platforms, and several molecular platforms, would there be a chance that 

would be enough to show that this works, I guess, just as well with all when 
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you compare the swab across, and therefore, that can be extrapolated for use 

across all platforms?

Timothy Stenzel: We’re open to creativity here. And so, I can’t make any promises, but you 

know, something along those lines is something that we can certainly 

consider.

Coordinator: Thank you. Our next question is from (Thomas Knott). Your line is open.

(Thomas Knott): Hi. Thanks for taking my call. Representing a firm that has a device that -

detecting COVID, but it’s not ELISA serology or antigen tests or PCR tests. 

And it uses kind of a non-typical specimen. It’s not invasive at all - very safe. 

It’s portable. It could be set up in an industrial or academic setting, and the 

analysis takes minutes.

It’s envisioned that it would use as a screening for a large number of 

participants - say, you know, in an academic setting or something like that -

identifying negative subjects who would go on - with, of course, using 

precautions with their normal activities. And those that are positive would be 

directed to take another confirmatory test. 

So, what - we need to know what you would like to see in an EUA 

application, or beyond that, a 510(k) or De Novo. So, interested in the process,

or maybe if we could set up a meeting, and how would I do that?

Timothy Stenzel: Okay. I didn’t catch the actual technology that you were mentioning. We 

have, for example, developed some recommendations that we can share for 

breath tests that work with...

((Crosstalk))
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Thomas Knott: That’s what this one - it’s a breath test, yes.

Timothy Stenzel: Okay. So, if you email our templates email box and ask for the breath test 

recommendation, they can provide you with their current thinking. And we 

are obviously working towards a template eventually, but it’s not all ready, 

and it’s not obviously not been cleared, otherwise we would post it.

Thomas Knott: Okay.

Timothy Stenzel: But we do have - a significant amount of thinking, already, and you can check 

the transcripts from last week because I went into some detail about our 

current thinking on breath tests, which may provide a little bit more 

information than our templates email box will respond with on our current 

recommendations for current thinking about recommendations for breath test 

validations.

Coordinator: Our next question is from Jessica DeLalio. Your line is open.

Jessica DeLalio: Hi there. Thanks for taking my call. Can you please provide an update on 

FDA’s review of laboratory-developed COVID-19 tests because it’s my 

understanding that HHS has contracted with NDA partners to help with their 

review of LDT EUAs. And also, that NCI may have some role to play.

So, at this time, should LDT developers continue to submit their EUAs to 

FDA? And does FDA have any additional details on either of the two 

alternative reviewers?

Timothy Stenzel: Thanks for that question. We at this time are still in dialog with HHS on this 

matter. Toby, do you have anything else on it?
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Toby Lowe: No, that’s correct. We’re engaging with HHS on that matter.

Coordinator: Our next question is from Michelle Rubin-Onur. Your line is open.

Michelle Rubin-Onur:Hello. Can you hear me?

Timothy Stenzel: Yes. 

Michelle Rubin-Onur:Perfect. Thank you. Thank you for taking my question.

My question is, would FDA find value in home-use serology testing and how 

it can support the vaccination efforts in determination of potential immunity 

for people who have either had COVID or have had the vaccine?

And does FDA expect to release a template for this type of product?

Timothy Stenzel: We’ve drafted a template for home serology testing. It’s not been cleared. As 

soon as it’s cleared, we will post it. You can send an email to our template 

email box, and we’ll give you our current thinking about recommendations for 

home serology tests. 

And if you are interested in any authorizations relative to vaccines, then we 

would ask you to draft a study design to demonstrate what you want to claim 

for your device and submit that study design as a pre-EUA for our 

consideration.

Coordinator: Thank you. Our next question is from (Yousef Peterson). Your line is open.
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(Yousef Peterson): First of all, thank you so much for hosting these calls. I’m the CEO and 

Co-Founder of a clinical CLIA lab in Boston, and we’re doing COVID 

testing.

I have a question about the process to validate tests that detects these new 

variants that we are seeing. Right now, we are only testing the standard test, 

but I see that becoming increasingly important.

Timothy Stenzel: Okay. I just want to clarify. You want to know what we recommend for 

variant testing?

(Yousef Peterson): Yes. 

Timothy Stenzel: Okay.

(Yousef Peterson): How would we go about getting an EUA for a variant test, compared to 

the current template for the standard PCR test?

Timothy Stenzel: Right. So, our current thinking on this - because there are so many mutations, 

and the number of variants that is - that are present and of concern is growing 

and there’s many different mentions of that.

Whole-genome sequencing may be a good modality to do genotyping because 

mutations can occur, you know, anywhere in the virus, and then we want to 

know about that. However, we are accepting applications for any subset of 

variants that a developer wants to review. 

I would hope that any work you do around variant testing wouldn’t be of 

value for just a short amount of time. So, it’s something to consider as you 

develop an assay because, you know, as soon as you might have a, you know, 
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a test that can identify the Brazilian, the UK and the South African variants 

and their various branches, you know, there may be some - a new variant 

that’s, you know, of importance that’s not on your test. 

So, that’s just, you know, the challenge in the current state of the pandemic, 

and with the biology that the virus has presented - the biological challenges 

that the virus is giving us right now.

Coordinator: Our next question is from Ron Domingo. Your line is open.

Ron Domingo: Hi. Thank you for the Town Hall. We’re a company that’s initiating studies 

for home collection and tests of a rapid antigen test, and it’s using a cartridge, 

a reader, and a phone app.

So, we’re using Abbott Binax as a model, and we understand from the 

authorization provided that it’s the obligation of the EUA holder to ensure that 

the telehealth provider has systems in place to properly manage prescriber 

obligation and patient support.

So, based on this, can FDA confirm that the EUA can be authorized without a 

specific telehealth provider identified in the EUA?

Timothy Stenzel: Let me ask a clarifying question. Do you - so we don’t require that you use a 

telehealth provider. That’s up to the test developer for home testing. So, if you 

choose to do so, you know, we would evaluate what they would do. Like if 

they’re online instructing a user how to use the test and get an accurate result, 

then we would look at that protocol that the telehealth provider would be 

going through.
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So, you know, if it was the same protocol, reviewers may be open to not 

limiting it to one telehealth provider if they have a standard protocol they’re 

going through. And it doesn’t necessarily matter who it is as long as those 

people are trained appropriately to be able to manage that call.

And of course, there’s a prescription pathway and an over-the-counter 

pathway for home testing. We are encouraging people to try to get over-thecounter testing, which does not require a prescription, and therefore, you 

know, there’s perhaps a greater ease of access to that kind of testing.

The thing with the telehealth provider is it could add cost, and I know there’s 

lots of folks who’d like to keep the cost down for this home testing as low as 

possible. So, those are just factors to consider.

But it’s up to the developer, like yourself, to decide the method that you’re 

going to do home testing, and the pathway and what claims you are going to

go for.

Coordinator: Our next question is from Cheryl Skinner. Your line is open.

Cheryl Skinner: Hi, yes, can you hear me?

Timothy Stenzel: Yes, indeed.

Cheryl Skinner: Great. Hello. Thank you so much for this Town Hall, and thank you for taking 

my question. 

I work for an immunodiagnostics company and the question I had is around -

we’re looking to propose claims to detect antibodies after vaccination - not 
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specifically immunity, but just level of detection - detecting antibodies after -

post-vaccination.

I understand for the home test there was a question that came up around 

serology testing and that a pre-sub would be likely your position to review 

this. Are you open to reviewing this type of claim? 

And if a pre-sub is the right method to submit this claim with the study 

design?

And then the third question is, what would be some of the requirements 

around to support this claim?

Timothy Stenzel: Yes. So, it’s always good to start with, you know, your intended use 

statement, as you would like to propose to the FDA. And how you write that 

and how you propose that will determine the validation study designs that 

would be appropriate to support those claims.

So, if you’re saying you can detect antibodies after a vaccination, you would 

want probably - you know, different antibodies may be accumulated by 

different vaccines. So, there may be, you know, data that we need to look at 

regarding each specific vaccine that you’re going to make a claim for.

Think of this as kind of a companion diagnostic test, right? And companion 

tests are specific for - we evaluate them specifically for each drug, even it’s a 

drug for the same - a different drug for the same target.

You know, and what data - and in your study design and proposal, you know -

what data would be, you know, important in your minds to show - to support 

the claim that you seek.
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You know, if you’re going to say, you know, after a vaccine - just a thought; 

I’m not saying these are recommendations - but if you’re looking at the 

impact of the vaccine, you’d probably want to have a test prior to vaccination 

to show that your test was negative. And then, after the vaccination, you 

know, how many days before it becomes positive.

So, we’ll want to definitely see, you know, how long it takes for how many 

people to be positive after a vaccine. So, those are just some high-level 

thoughts that you should consider in putting together your study design and 

submitting it as a pre-EUA.

Coordinator: Our next question is from Joanne Gonzalez. Your line is open.

Joanne Gonzalez: Hi. Thank you for taking my question. I’m involved in a clinical trial to 

support a prescription home-use EUA, with plans to submit shortly 

afterwards. But we will continue the trials to obtain enough asymptomatic 

subjects to support an OTC EUA. 

If I’ve already submitted my prescription home-use EUA and want to now 

pursue the OTC EUA, how do we effectively transfer that review over to an 

OTC review?

Timothy Stenzel: Typically, the same review team that reviewed the prescription test - home 

test - can evaluate the asymptomatic data needed for us to authorize, you 

know, for asymptomatic use and update the test for an over-the-counter 

situation.
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So, you know, that’s a very legitimate and efficient way to go about validating 

your test and getting your first authorization and then making a supplement 

later to update your authorization from RX to OTC.

Coordinator: Our next question is from Christy Bergerson. Your line is open.

Christy Bergerson: Hi. It’s me again. I just had a follow-up to my earlier question.

So, when we are transferring ownership of an EUA, is there any vetting of the 

new company that we should consider or think about to propose as we prepare 

for the transfer? Like, what information would our reviewer be interested in?

Timothy Stenzel: I think it’s just a matter of the, you know, listing a new - changing out the 

legal manufacturer and, you know, the company that’s transferring it to the 

new entity would need to give their permission, and we would review that.

And you know, we’d want assurance that the test was going to be 

manufactured in the same way, and all the conditions of the original 

authorization would be transferred to the new owner.

Coordinator: Our next question is from Ron Domingo. Your line is open.

Ron Domingo: Hello, can you hear me?

Timothy Stenzel: Yes.

Ron Domingo: Okay. Thanks again, Tim.
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So, FDA has indicated that they’re likely to authorize three De Novos. Are 

these likely to be molecular, antigen, antibody, or moderately complex pointof-care or OTC?

Timothy Stenzel: So, we’re - you’re talking about the conversion from an EUA to a full 

authorization for anything SARS-related. We are currently reviewing, you 

know, the most efficient way we’re going to do that. And if you want to do 

that any time soon, and one hasn’t been authorized, of course, we would 

expect a De Novo submission.

And then, as we’re looking at it, there may be a way to make it more efficient 

around a single technology like molecular, or around antigen, or around 

serology. And we’re currently looking at that in order to minimize as much as 

possible the number of De Novos for the pandemic as possible. 

Toby, do you have anything to add? I know that we’re still discussing that 

topic internally.

Toby Lowe: Yes, I think that’s right. We haven’t necessarily finalized that process, and 

that may not be finalized until we get the first De Novo authorized.

Coordinator: Our next question is from Joanne Gonzalez. Your line is open.

Joanne Gonzalez: Hi again. Are fact sheets for patients required for at-home tests if the content 

in the patient labeling and FAQs include the content typically found in fact 

sheets for patients? I’ve looked recent EUA authorizations for at-home tests 

and saw that FDA indicated that content typically found in fact sheets for 

patients were provided in other labeling.

Timothy Stenzel: Hold on, Joanne. You’re talking about a home test or home collection?
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Joanne Gonzalez: Home test.

Timothy Stenzel: Home test. Prescription or OTC?

Joanne Gonzalez: Prescription.

Timothy Stenzel: Prescription home test. Okay. So, I don’t remember what we’re asking to see 

on a prescription home test. 

Toby, do, you know, what we’re currently asking in that content?

Toby Lowe: Yes. I think, you know, in terms of fact sheets, it’s the content that is most 

important and, you know, that it is provided to the user in an accessible 

format. So, that’s something that we would work with you on during the 

review to determine whether, you know, whether that information can be 

included in other ways than a separate fact sheet such as you mentioned - the 

FAQs or other labeling to just streamline that process.

Coordinator: Our next question is from (Richard Montagne(. Your line is open.

(Richard Montagne): Thank you. We already have an authorized COVID-19 test, and we also 

have submitted an EUA for an expanded respiratory panel that includes Flu-A, 

B, RCA, B and SARS CoV-2. 

My question is that during the interactive discussions for the pre-EUA for the 

expanded respiratory panel, we were advised by FDA that for the current flu 

season, that EUA authorized test would be permissible. But beyond that, we 

would require either 510(k) or a De Novo.
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And inasmuch as the incidence of flu is so low this year, for obvious reasons, 

it’s going to be difficult, I think, to obtain the number of samples that FDA 

had recommended that we use in the clinical studies.

So, my question is, has FDA had any additional thoughts on that, or should we 

still assume we’re going to have to have a cleared assay for the subsequent flu 

seasons, which may mean going into the Southern Hemisphere this year.

Timothy Stenzel: So, there, thankfully, for patients, you know, there isn’t much flu out there. 

Probably due to the precautions we’re all taking to prevent transmission by 

SARS, which appears to be obviously much more transmissible, even with 

precautions.

So, I would ask that you send an email to our templates email box and ask this 

question that I can look into specifically with regard to your own application. 

Ask for Toby and Tim to get involved after you send that email onto the -

when you send that email to the templates box, and either Toby or I will look 

into this further.

Coordinator: Your next question is from Ron Domingo. Your line is open.

Ron Domingo: Hi again. Tim, I just wanted to loop back on the De Novo discussion earlier. 

So, what happens if I submit my De Novo, and you’re already reviewing 

someone else’s De Novo for the same indication. Will my De Novo be 

rejected? And will I have to retest my devise against the predicate? Thank 

you.

Timothy Stenzel: No, it would get converted, and I believe we would refund the difference 

between a De Novo and a 510(k). You would not have to make a new 

submission.
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Ron Domingo: Great. Thank you.

Coordinator: And at this time, I’m showing no further questions.

Timothy Stenzel: And actually...

((Crosstalk))

Irene Aihie: (Over to Tim)? Operator, do we have any other questions?

Coordinator: Yes, I’m sorry. One just came into the queue. One moment, please.

Irene Aihie: Okay.

Timothy Stenzel: Well, then, as they’re coming into the queue, I am going to turn the call over 

at this time over to Toby because I have another meeting that I’m going to 

need to attend. I’m leaving you in the great hands of Toby. Thanks, everyone.

Over to you, Toby.

Coordinator: And our next question is from Brian. Your line is open.

Brian: Hello, thank you, this is (Brian Sell). Just wondering; is FDA accepting Q 

subs or reclassification requests at this time for COVID for a De Novo 

submission?

Toby Lowe: By reclassification request, you mean the De Novo submission itself?

Brian: Yes, so, you guys are accepting the Q subs for the De Novo submission - for a 

De Novo submission?
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Toby Lowe: Oh, a Q sub for a De Novo?

Brian: Yes.

Toby Lowe: Yes. We are at least entertaining them, depending on what the content is and, 

you know, what the questions are, and if they go beyond what is available 

elsewhere. We may or may not be able to dedicate resources to it, but you can 

certainly submit a Q sub and we will consider it.

Coordinator: Our next question is from (Luis Silvestre). Your line is open.

(Luis Silvestre): Thank you. This is a question from one of the previous sessions. Can you 

confirm that there is no universally recognized, certified, commerciallyavailable formulation for viral transport media to be used with nasal swabs, is 

Question 1.

And Question 2, has the FDA became aware of any differences in reactivity 

for antigen testing, depending upon the commercially available transfer media 

that is used?

Toby Lowe: Can you repeat the first part of your question about the VTM?

Luis Silvestre: Whether or not - or can you confirm, that there is no universally recognized 

formulation there is - from commercial manufacturer to commercial 

manufacturer - there isn’t a standard or certification that is required to have 

the exact same formulation? Can you please confirm that that is indeed the 

case?
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Toby Lowe: Correct. Yes. Different manufacturers make different formulations for their 

proprietary transport media. Yes, we have issued a guidance document on 

transport media that references the CDC formula, and, you know, we have 

provided some regulatory discretion for manufacturers that are conforming 

specifically to that CDC formula.

And then, you know, you had asked about the differences with different 

transport media being used in the antigen testing. And yes, there are 

differences, and we do review specifically the transport media - the specific 

transport media being used with a specific antigen test when we look at the 

EUA requests for antigen tests.

Coordinator: Our next question is from Shannon Clark. Your line is open.

Shannon Clark: Hello, again. Shannon Clark with UserWise Consulting.

Question about - I’m really looking forward to this template coming out for 

this home-use test kits for antibody testing. Do you expect that it’s going to 

require a sample size of 30 participants for prescription-only; then 150 

participants, or 100 sessions with some pairs for over-the-counter? Because 

I’ve received conflicting emails from the FDA implying that perhaps OTC 

could be achieved with a sample size as low as 30.

Toby Lowe: I don’t - I can’t speak to what exactly will be in that template. Hopefully, we 

will be able to get it out soon so that we will be able to speak to it more 

definitively. 

But if you do have specific questions as you’re planning your approach now, 

you can send them to the mailbox. And if you’re having difficulty getting a 
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02-10-21/12:15 pm ET

Page 23

uniform answer, you can flag the question for Tim and me, and we’ll take a 

look into it.

Coordinator: Your next question is from Jackie Chin. Your line is open.

Jackie Chin: Hi. This is Jackie calling in Palo Alto. I have a question about - as we go 

through an EUA - that and process through the EUA.

Toby Lowe: I’m sorry. We’re having trouble hearing you. Can you maybe move closer to 

your speaker?

Jackie Chin: Hi. Can I try this again? Let me try my question again.

Toby Lowe: Much better.

Jackie Chin: Thank you. My question is about the software validation requirement for EUA 

submission. And on the template, there are two tables. One is the system 

specification and validation example. And the other one is the passive analysis 

example.

On the first table, it asks for evidence that the design of the system can fulfill 

the specifications. For the EUA submission, do we just have to reference the 

validation test plan and test report that we have? Or should we submit the full 

documentation because that is a lot as well.

Toby Lowe: You can start with a summary report, and if we have additional questions, we 

can follow up. Does that answer that question?

Jackie Chin: It’s okay to just fill out this table and include this table in the EUA 

submission?
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Toby Lowe: Right. So, we would want to see a summary report indicating what has passed 

and what has failed.

Jackie Chin: Okay. Thank you. Thank you, Toby.

Toby Lowe: Sure.

Coordinator: Our next question is from (Kodumodi Venkat). Your line is open.

(Kodumodi Venkat): Good afternoon. Thanks for taking my question.

My question is about the submissions for the serology assays that I submitted 

many months ago, and still, we are getting it’s a low priority. So, is there -

because last week Tim was mentioning that you are reviewing at least nine 

applications a day or something. So, is there any possibility some of those 

applications that are waiting for many months, that they will get assigned a 

reviewer and then reviewed any time soon?

Toby Lowe: So, we have indicated, you know, in our FAQs and in other talking points, 

what types of tests we’re currently prioritizing. Those are generally tests 

where the authorization would increase test accessibility or significantly 

increase testing capacity.

So those remain our focus right now. Other tests, we would move into the 

review queue once we have gotten through the priority submissions.

Coordinator: Thank you. Our next question is from Jennifer Lee. Your line is open.
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Moderator: Irene Aihie

02-10-21/12:15 pm ET

Page 25

Jennifer Lee: Yes, hi, Toby. Just a quick question. And I was able to join only by audio 

today, so I missed a slide. Is there a Website or somewhere to learn more 

information about that new funding opportunity between HHS and DoD?

Toby Lowe: Yes. The slide that was projected will be posted on our - on the Town Hall 

Website. And that does include a link.

Jennifer Lee: So, there’s nothing to access today to learn about it?

Toby Lowe: You can always send me an email, and I can send you the link.

Jennifer Lee: Okay, wonderful. Thanks so much.

Toby Lowe: But it will be posted fairly quickly.

Jennifer Lee: Great. Thank you.

Coordinator: Our next question is from Brian Jones. Your line is open.

Brian Jones: Yes, I was looking at the EUA template, and it has instructions for doing a 

comparison study between paired NPS and saliva specimens. And so, in our 

case, we would be - we have a device that’s already has EUA for NPS. So, we 

would be testing that - those specimens - on our device, both as the candidate 

for the saliva and then the NPS that’s already authorized.

My question is, there’s no information in the template about doing 

discrepancy investigation, and I just wondered if there was any input from 

FDA on that.
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Page 26

Toby Lowe: So, first we would recommend that you use a different test as a comparator

and, you know, we would recommend that you select one that has high 

sensitivity. If you take a look at our reference panel information, that’s a good 

starting place to select a comparator test with established high sensitivity.

And then, so, can you repeat the second part of your question?

Brian Jones: Oh, so, sorry. Just to clarify on that, would that be a comparator on both 

specimen types or on only one of those specimen types?

Toby Lowe: So, if you’re already authorized for NP, then - and you’re seeking a claim with 

saliva, we would expect you to run - use an NP comparator on a separate 

authorized - on a separate comparator test that is authorized for NP swabs.

Coordinator: And at this time, I’m showing no further questions. I’ll go ahead and turn it 

back over to you, Irene.

Irene Aihie: Thank you so much. Again, 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 Web 

page at www.FDA.gov/training/CDRHlearn by Friday, February 19th.

If you have additional questions about today’s presentation, please email

CDRH-EUA-templates@FDA.HHS.gov.

As we continue to hold these virtual Town Halls, we would appreciate your 

feedback. Following the conclusion of 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 
FDA Townhall

Moderator: Irene Aihie

02-10-21/12:15 pm ET

Page 27

www.FDA.gov/CDRHwebinar. Again, thank you for participating, and this 

concludes today’s Virtual Town Hall.

Coordinator: Thank you for participating in today’s conference. All lines may disconnect at 

this time.

END