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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on 

Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

August 5, 2020

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 session of today's conference. 

At that time to ask a question from the phone lines please press Star 1 and 

record your name when prompted. This conference is being recorded. If you 

have any objections please disconnect at this time. I would now like to turn the 

call over to your host. 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 20th 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, Timothy Stenzel, Director of the Office of In Vitro Diagnostics and 

Radiological Health in the Office of Product Evaluation and Quality, and Toby 

Lowe, Associate Director of the Office of In Vitro Diagnostics and 

Radiological Health, both from CDRH, will provide a brief update. Following 
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opening remarks, we will open the line for your questions related to today’s 

discussion. Please remember that we are not able to respond to questions about 

specific submissions that might be under review. 

Now, I give you Timothy...

Dr. Timothy Stenzel: Thank you Irene and hello again everyone and thank you for joining us. 

And we greatly appreciate everything you're doing to help out in this pandemic. 

We passed a new milestone recently. We have authorized now over 200 tests in 

the EUA pathway. And thanks to many of you for that accomplishment. 

Without developers like yourselves doing this, we could not have achieved that 

goal.

We are going to have many many more. We have hundreds of EUA 

applications in house. And the vast majority of these have come through the 

notification pathway so that they are able to if they do that if that's allowed to 

them you are all able to go out and market your test prior to EUA authorization. 

It is the honor system. We expect that the validations have been done well, the 

performance is acceptable and we thank you for that.

We allowed this pathway in this pandemic because of the absolute huge need to 

provide testing in abundance as soon as possible. And so please do bear with us 

as we go through these applications for EUA authorization. We obviously have 

to have a prioritizing so that we make the best decisions possible in all cases. So 

everyone's EUA is important and we will get to them.

Please work closely with the contact that we've provided. Again for EUAs, not 

pre-EUAs, for EUAs direct to the office make sure that every EUA applicant 

has a contact within two weeks of submission hopefully less time now. And 

that's important that you have a contact that you can get at least weekly updates 

from. 
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And those that do require an EUA prior to launch they obviously get triaged. 

For those new submissions new technologies that require an EUA, they do get 

higher priority because they are waiting EUA authorization to be able to get to 

the market versus those who come through the notification pathway.

The second update has to do with pooling. Of course there are, there's a greater 

need for tests than available tests and turnaround times at labs have increased. 

One of the potential solutions to this is that we find a way to pool. Pooling in all 

cases appears to decrease the percent positive rate that is low positives are 

going to be missed. And that's just a given if you start pooling.

We want to limit those misses to an acceptable level. And our updated 

templates call for a PPA relative to single tests on the platform of 85%. You can 

pool up to as many as you want as long as you hit that number. We are asking 

for an even distribution of levels of positivity so a good range of low positive 

and high positives, up to high positives. 

So there's not an overabundance of either, an overabundance of low positives if 

it doesn't match your distribution in your lab which is the ideal thing is to match 

the distribution your lab sees then, you know, it's not as helpful. So we'll work 

closely with you to make sure that that distribution is good.

The pathway for pooling additions both for kit developers as well as labs to 

alter kits and/or alter their own LDTs is through the notification pathways. So 

validate whatever pool scheme you want to use. Make sure the performance is 

good. On the honor system, you can notify us and submit your data within 15 

days. All the while, 15 business days, all the while continuing the test pools 

unless you hear any concerns from us.
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And we'll get to those applications as soon as possible. They are a priority now 

so that we understand the variables that go into developing a pool scheme. 

There are multiple schemes. We have seen tremendous variability between labs 

that have tried to validate pooling even with the same kit.

So for example somebody might fail the bar at a lower sample pool where 

another lab seems to pass and so we are gaining more and more information 

about why that might be. It seems to be driven by two different things at least 

but these are probably the major drivers of pooling success. And that is the 

LOD of the assay. Obviously a more sensitive assay will be less likely to miss 

the average low positive than a test that is pooled that has not as great a 

sensitivity.

And then second is the distribution of low positives in a given labs menu and 

experience. So it's important to understand historically what your low positive 

rate is. We like to see CTs historically for the labs to help them guide them to 

the right pool scheme. It will give them great performance with pooling and 

balance the need to increase throughput with getting an acceptable performance 

and not missing a lot of positives.

And then finally I wanted to mention that recently we did authorize the first 

semi-quant serology test in fact there were two of them that we authorized 

semi-quant, quant and neutralizing antibody serology tests will be a priority 

going forward. There is a lot of interest relative to vaccines as you might guess. 

So we are working closely with any party that any developer that wants to 

advance development of these tests. And we look forward to more and more 

authorizations.

It is a bit more complicated to semi-quant, a bit more complicated to do a 

neutralizing essay or to correlate a given serology test to a neutralizing assay. 
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So we look forward to working with you. And with that, that ends our 

introductory remarks today and we can turn it over to questions. Thank you.

Irene Aihie: Operator, we'll now take questions. Hello, operator are you there?

Coordinator: Yes I'm here. My apologies. We will now begin a Q&A session. To ask a 

question over the phone lines please press Star 1 and ensure your phone is 

unmuted and record your name at the prompt. Your name is required to 

introduce your question. 

To withdraw your question press Star 2. One moment please for incoming 

questions. We do have a few questions in queue. One moment, please. Our first 

question comes from (Elisa Maldonado-Colbert). Your line is open.

(Elisa Maldonado-Colbert): Yes. Thank you. Question regarding readers, after receiving EUA 

approval for an antigen test with a reader. If we validate a new reader after our 

internal validation do we need to submit a new EUA. Thank you

Dr. Timothy Stenzel: That would probably be a supplement to your existing EUA. And the 

validation requirements would depend on how closely the second reader 

performs relative to the first reader. Without knowing those differences and 

how you do that it's hard to predict and give you feedback in the short time we 

have on this call. That would, if the antigen test itself is the same just different 

readers that will be more straightforward and can be a supplement to your 

existing application

(Elisa Maldonado-Colbert): Thank you so much

Coordinator: Once again as a reminder to ask a question from the phone lines please press 

Star 1, unmute your phone and record your name at the prompt. Please limit to 
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one question per caller. Our next question comes from (Shannon Clark). Your 

line is open.

Shannon Clark: Hi. This is Shannon Clark with UserWise Consulting. We conduct human 

factors testing for medical products and I did email you Timothy about this. For 

viral sample collections using swabs, the template includes 30 unchanged 

subjects using the swabs all are negative for SARS-CoV-2. And we directly 

observed these as uncovering use errors.

My question is about the lateral flow test kit because for those it only requires 

five health care providers ten less than the FDA minimum number of human 

factors, no direct observation and it requires 30 antibody-positive finger stick 

samples.

So I was just wondering if the purpose of this point of care testing to uncover 

use problems and if so why doesn't it include and require observations? And 

why does it require positive finger stick samples? But if the purpose of the 

testing is for clinical agreement or test accuracy can you confirm that it is not 

considered human factors testing?

Dr. Timothy Stenzel: So there's a lot of questions in there I'd like to unpack things one by one 

quickly. One is why do we require 30 finger sticks that's because that sample 

type is physiologically different than other serology sample types. And we want 

to observe performance particularly on the lateral flow device that is equivalent 

to serum plasma or venipuncture whole blood. And so we do need to see the full 

30 positives and that's a much lower level than we would normally require for a 

submission and that's because this is a EUA.

There were a number of other questions and I am not sure that I caught all of 

them. I think one of them is why for point of care. do we only require four or 
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five or so users. It's because they are health care workers and they are 

experienced in many cases with running point of care devices.

So we don't feel like the training, the users that have previous experience with 

various potential point of care devices we don't under the pandemic we don't 

feel like we need to for EUA we don't need to see quite as many as for 

non-healthcare worker situations where because we require so much less of a 

validation relative to a non-EUA situation we want to see more users who are 

unskilled and are not health care workers to make sure that they get accurate 

results. And there might have been some more questions in there and just want 

to pause and see if there's any clarification.

Shannon Clark: Yes can we just confirm that the point of care testing that is required by the 

template is not human factors testing and that you can just send a follow-up 

questionnaire to these health care providers you're not required to observe for 

use errors as you would in traditional human factors testing?

Dr. Timothy Stenzel: So for health care workers in health care settings performing the point of 

care testing we do not typically recommend for authorization for observation. 

Now a developer may want to do that to make sure, you know, that everything's 

working fine, that the workflow is great that users don't have difficulty, you 

know, more commercial marketing purposes.

Shannon Clark: Thank you so much. So we'll just proceed with advising our clients that the 

purpose is a point of care testing is for clinical agreement and/or test accuracy 

not for uncovering use errors.

Dr. Timothy Stenzel: That's true. I mean in performance in experienced hands such as health care 

workers sort of factors some of those things in already okay? All right thank 

you.
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Coordinator: Our next question comes from (Dana Hummel). Your line is open.

(Dana Hummel): Hi. Thank you for taking my question. It's kind of a follow-up to the last 

question. For the section regarding point of care studies for the robustness of 

the test, you know, testing different volume samples, different lighting, is that 

required to use finger stick whole blood samples or could we use other sample 

types such as venous whole blood, plasma or serum or even controls with 

recombinant antibodies?

Dr. Timothy Stenzel: Yes. So I think you're talking about a serology test. And I do believe it does 

give you options on how to do that. Primarily we want to understand how does 

the test perform, if they are available that aren't controlled by the test 

themselves that are user-dependent time, volume observations. And even if you 

have a, you know, like a smartphone reader the lighting conditions matter.

So for those Toby, you know, might have this more at your fingertips than me 

but those things can be tested more analytically in the lab rather than with actual 

finger sticks. And I'm just going to that section but I don't think I have time to 

go to it right now.

But any additional questions that aren't clear from the template, the serology 

template for commercial manufacturers please just ask our team. But I believe 

there is advice for how to do that without having to use actual patient, direct 

patient material.

(Dana Hummel): Okay. Can we perform these tests outside of the US or are they required to be in 

the US?

Dr. Timothy Stenzel: There's no requirement to perform those tests within the US...
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(Dana Hummel): Perfect. Thank you so much.

Dr. Timothy Stenzel: ...for those for those questions. Thanks.

(Dana Hummel): Thank you.

Coordinator: Our next question comes from (Neil Armstrong). Your line is open.

(Neil Armstrong): Thank you. Hi Tim and Toby. Thanks as always for doing this and really 

helping us out. Our product is a general diagnostic device. It's not specifically to 

detect the COVID-19 disease but because it detects changes in the body we 

believe it's got an application in staging the progression or recovery from 

COVID-19.

We got a lot of help early on in getting through this sort of template process and 

getting them into the right sort of format to put our information in. But recently 

we seem to have ground to a halt. We now believe we're in a position where we 

could put in a 510(k) for a general indication. And we appreciate you guys are

just really busy on all the EUAs for the same sort of normal testing.

Should we put in a 510(k) for a general indication knowing that people may be 

using it off label for staging COVID-19 progression? Should we pursue the 

EUA route? Should we do both? If we put in 510(k) should we asked for an 

accelerated or expedited review? Really what's the best way of us moving 

forward on something that probably isn't your first priority and may take a bit of 

review time?

Dr. Timothy Stenzel: So yes things that are not targeting SAR-CoV-2 or antibody response to 

SAR-CoV-2 we have been bringing in non-microbiology review staff -- even 
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though there may be a microbiology component to it right -- because the desire 

to appropriately assess these technologies that can potentially assist in the care 

for COVID patients. So I without knowing the details of the process and your 

specific situation it's hard for me to advise.

Where possible we do want to follow the EUA route. We do follow closely the 

regs and guidance obviously for determination of what qualifies for an EUA. 

And we've been in some cases in many cases very flexible in adopting those 

things into the EUA process.

For example, multi-virus or multianalyte panel testing isn't something that was 

too clearly, you know, something that's a EUA because it detects viruses and 

other respiratory pathogens that aren't directly COVID related. So if you've 

gone to the halt and I hate to suggest this because my e-mail box is crazy but if 

you send it to me and you copy Toby so send it to the templates email address 

ask Toby and Tim. or Dr. Stenzel copied I'll get to it as soon as we can and help 

unblock this and make some specific suggestions for you to help your out.

(Neil Armstrong): Thank you. Thank you very much. Really appreciate that. Great of you.

Coordinator: Our next question comes from (Sarah). Your line is open.

(Sarah): Hi. And we're looking for some clarification on the stance for university student 

testing. The updated FAQs indicate broad screening requires a EUA but that 

healthcare ordered tests can be completed under the current authorized EUAs.

If our student testing is completed under a health care provider order as 

suggested was acceptable on our previous call from their high-risk status do we 

still need to submit a EUA for this screening and if so can the data be 

retrospective or should it be collected prospectively?
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Dr. Timothy Stenzel: So our - when it comes to molecular diagnostics tests and use in screening,

if the test that you're using is a EUA authorized and/or notified a test and it 

doesn't have any particular limitations, maybe due to some sensitivity or some 

issues that we've seen, then they can be used in the screening slash 

asymptomatic population when there is a health care worker prescription order.

And we're allowing that very clearly on our FAQ site. FAQs we encourage labs 

to accept these samples even though they may be screening or asymptomatic 

patients if they have valid orders and to report those results.

And for that purpose, there's no necessary change to a EUA unless that EUA 

wants to claims, you know, that they have a certain level of performance in the 

screening population. And then we will want to see data in the screening 

population that would support that claim that their test has a certain level of 

performance in the asymptomatic or screening population. And our templates 

go into a lot of different details about, you know, how to go about getting that.

So for example, if you're, if you already have a EUA authorized test, you know, 

there's a pathway to add that screening asymptomatic claim. If you're, have an 

entirely new test and you want to go directly for that asymptomatic pathway if 

you want to have an OTC test there's a different pathway, et cetera, et cetera. 

So the details have gotten such that it's hard for me to keep them all straight but 

it's all laid out in the templates if you have any questions about that. But if 

you're not going for, you know, wanting to advertise that you're testing has a 

certain performance in the screening asymptomatic population you're fine. Just 

accepting the health care worker orders slash prescription, doing the testing and 

reporting it. Hopefully, that helps.
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(Sarah): Okay yes. Thank you so much.

Coordinator: Our next question comes from Martha Casassa. Your line is open.

Martha Casassa: Hi. Thank you for taking my call. I am calling on behalf of the Clinical Lab 

Management Association. We are looking way in the future and wondering 

what is the plan once EUAs are lifted? What will be the status of all these assays 

and what will be required of laboratories to be compliant? Can you answer 

those questions, please?

Dr. Timothy Stenzel: Yes. So I think what you're saying is once we begin to authorize regular 

submissions and potentially if the emergency should come to an end what is the 

status of all these EUAs and what would be the plan for them at that point, 

correct?

Martha Casassa: Correct.

Dr. Timothy Stenzel: Yes so obviously this is very important. I will say that many of the previous 

emergencies are still declared and most of them have not been converted to 

regular submission. Some of them do and we certainly wish them to be able to 

do that. And we work with them to achieve that. And we've achieved that. I 

think for an Ebola test and the Zika test for example.

And so we don't know what decisions are going to may, be made regarding this 

emergency. I certainly don't foresee it coming to an end but I'm not the one 

making the decision. And you can rest assured that we will have, you know, a 

plan that will work for most everybody taking all these considerations into 

place.

So the thinking, a lot of thinking has already gone into this. So the other thing 
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that you say, as soon as we can make those plans public we will do so. So we're 

already thinking about that. So I don't know that it should be a concern. I 

certainly don't personally think that it's a concern for any of the developers out 

there right now.

Martha Casassa: Excellent. Thank you so very much. Have a great day

Dr. Timothy Stenzel: Thanks. You too.

Coordinator: Our next question comes from (Pamela Turbeville). Your line is open.

(Pamela Turbeville): We purchase qualitative serology tests IgG, IgM that only have an EUA. 

We read the results visually positive or negative. And then our app digitizes the 

person's data, saves a picture of the cassette and then reads the test results and 

sends a photo and the qualitative result to the person's phone

However in parallel, we have a reader with an app that also quantifies the 

antibody scores from the serology test. We're not sharing the data with the 

individual but we are using it to build validation data for the EUA application in 

the future. So our question is can we proceed to test individuals, provide them 

qualitative data per the third parties IFU and then capture the data, the 

validation data, and then compile it into a EUA application in parallel?

Dr. Timothy Stenzel: So I just want to check a few things. So you are taking somebody else's test 

probably not your own?

(Pamela Turbeville): Right.

Dr. Timothy Stenzel: And you've developed a smartphone app that takes a picture of the visually 

read lateral flow device. The data isn't, the data that's input, you know, and it, 
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and this potentially would go to the health care provider medical record and/or 

or a patient even. The test is visually read by the appropriate person who is 

authorized to do that.

(Pamela Turbeville): Right.

Dr. Timothy Stenzel: Most cases that would at the moment I don't think we have any point of care 

but for serology. But in which we're very interested in and we'll work with 

developers to achieve that. But, you know, they're - then they're moderately into 

high complexity lab situations now.

So those workers would read that test. They would record that result in your 

software package along with a photo capture of the results. Are, is your device 

currently reading the strip itself and making a determination of either 

qualitative results and/or semi-quant results?

(Pamela Turbeville): Okay the strip itself provides the qualitative results. So we tell it care, tell 

the person right away yes or no. So that is just the operating procedure that's 

done. But what we're doing, in addition, is we take the test cassette. We're 

putting it into our device that sits on a smartphone, insert it, press a button and it 

quantifies it. We record that data. We're using that data for our own future 

submission for EUA.

Dr. Timothy Stenzel: Yes. So that would be considered a device because you're actually doing 

analysis of the results of the test and coming up with a new output...

(Pamela Turbeville): Right.

Dr. Timothy Stenzel: ...based on the - that device's analysis. So there are two pathways. There's an 

easier pathway and there's probably a very difficult pathway. One is to work 
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with a given developer who already has a task and do the performance 

measurements and validation on that test for use with that test.

And that can be - there are various pathways for that. If you're, you know, test 

developers themselves can submit everything, you know, and update their EUA

potentially or you can stay independent. We can figure out how to do that 

basically which team writes better reference letters.

And we would probably update both, you know, give the - your smartphone 

application that’s on EUA and then we would also update the package insert of 

the test to say that it can be used with this device. If you wanted to have a more 

broad claim that would work on multiple platforms, multiple tests could be a 

little bit more challenging because there's obviously variability in those tests.

And that would be fairly challenging given, you know, sometimes the reads are 

different, locations are different, colors are different, intensities are different, et 

cetera, et cetera. et cetera okay?

(Pamela Turbeville): Got it. Thank you so much.

Coordinator: Our next question comes from (Gabe Olin). Your line is open

(Gabe Olin): Hi Tim. Hi Toby. Thank you for everything that you and others are doing. I'm 

working with a university-based lab that's developing a NexGen sequencing 

platform for massive diagnosis for students who are coming back to campus on 

the order of about 100,000 tests in a single day using saliva.

In the molecular diagnostics template, there's a requirement for alternative 

respiratory specimens to each 95% PPA with an NP swab sample. And I'm just 

wondering, knowing that our specimens in different areas in the respiratory 
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tract have different concentrations of virus, if you think that this is going to be a 

pretty rigid rule to maintain 95% PPA in this kind of setting?

Dr. Timothy Stenzel: Also are you going to try to pool to get a pool actual saliva samples before 

you begin testing or you're going to just do a massively parallel and test saliva 

samples individually and use bar codes to convolute and de-convolute?

(Gabe Olin): The latter, so massively parallel and they'd be unpurified saliva specimen which 

is what allows it to be so scalable.

Dr. Timothy Stenzel: Okay so we've found saliva to be an incredibly unpredictable when 

challenging substrate. I mean and we've really not ever considered testing 

saliva for a respiratory virus and authorized it before to my knowledge. This is 

incredibly unique, you know, and we're open and flexible and adaptable to 

different approaches.

But we've seen and denied some saliva submissions because of performance. 

And we are aware of multiple developers who have just decided that saliva's too 

tough. Obviously there are advantages to saliva right, easy to collect. You don't 

need - you may not need transport media or if you do it’s in a device that's easily 

used. And we've authorized tests with some devices already.

And you don't need, you know, swabs. You don't need VTM per se. And so 

there are huge advantages to being able to use saliva. So we just ask the 

developers and if they want to - and saliva can be added to a EUA test without 

an FDA submission if it's an LDT. Obviously kit manufacturers they can - it's a 

notified pathway they can validate saliva, notify the FDA and in 15 business

days submit their saliva EUA package.

But for labs that want to either alter a kit or alter their own LDT, we don't 
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require a EUA submission for that. And but we do ask that you validate it well. 

And we have come to believe that a comparison to NP swab is critical to 

understanding the performance and the performance limitations of saliva. And 

we don't - I don't think we acquire that much. I mean it's basically 30 positives. 

And we understand that nasal pharyngeal swabs are sometimes hard to obtain.

A good second choice for an NP to saliva comparison would be a mid-terminate 

sample, mid-terminate swab sample. I think most students patients would much 

prefer to have a mid-terminate to an end - to a nasal phrayngeal swab. So that is 

also acceptable to us right now.

We are trying to discourage nasal swab to saliva because there is the potential 

for additional loss of sensitivity in the nasal swab. And we have found in many 

cases now that that comparison is not the best comparison to use going forward. 

So hopefully that helps.

(Gabe Olin): Got you. It does. Yes, I think, you know, we have a pretty strong limit of 

detection with our assay. And so I think maybe some of the loss in sensitivity 

can be made up for by frequent testing on a more regular basis. So just curious 

if that would come into consideration when comparing to the NP swab but 

great. Thank you.

((Crosstalk))

Dr. Timothy Stenzel: We do allow in a performance of a molecular test and also a direct antigen 

test down to an 80% sensitivity or PPA for almost anything. We do request that 

anything that generally falls below a 95% sensitivity compared to a good swab 

sample or another good test be labeled with the negatives being presumed 

negative rather than actually negative.
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Because if you're missing up to 20% of positives we think that the clinicians 

should know that and make sure that the situation that they're getting that 

results on doesn't warrant a follow-up swab test, for example, to make sure the 

patient is absolutely negative.

(Gabe Olin): Okay. That's good to know. That's actually what we're intending, is to then if 

they get a negative they'd be - they would then get an NP swab. So thank you 

very much, Tim. I appreciate it.

Coordinator: Our next question comes from (Daniel Marcus). Your line is open.

(Daniel Marcus): Hey so my question is related to the notification pathway. Specifically in the 

May 11 guidance, you guys use the term distribution and that it's okay for 

commercial manufacturers to distribute the tests. And in this conversation, you 

mentioned the term market.

I'm just wondering what that looks like with respect to commercialization and 

what developers and manufacturers are capable of doing as far as being able to 

see any sort of financial reimbursement for their tests? That's question one.

And question two is you guys specify two, basically two entities that can -

where these tests can be distributed which is high complexity CLIA labs and 

healthcare workers at the point of care. Is - so I'm wondering what, you know, 

what that definition of healthcare worker at the point of care looks like and 

whether those have to be high complexity CLIA lab personnel or they could be 

any healthcare worker at the point of care? But I'd love to get the first question 

answered first and the second one is just icing on the cake.

Dr. Timothy Stenzel: I'm going to actually reverse them because I'm going to hand the second the 

first one over to Toby for her thoughts after I first try to address it just to make 
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sure she doesn't have anything else or any corrections on what I say.

Toby Lowe: Sure, happy to.

Dr. Timothy Stenzel: But we authorize tests under EUA and we give clear indication on whether 

that test, where it should be performed, whether it's a high complexity lab, 

moderate complexity lab point of care which are healthcare settings with 

non-laboratory personnel, non-lab collection including home collection, 

non-lab testing including home testing and whether that that non - and whether 

that non-lab testing is by prescription or it's over-the-counter without a 

prescription.

So there are all these various scenarios. And if we have said that either a test is 

moderately complex or highly complex then it should not be used in a point of 

care setting except as is allowed under a moderately or high complexity lab’s 

CLIA certificate. So it cannot be performed only under a waived certificate. 

Now hopefully that provides some clarification.

(Daniel Marcus): Okay.

Dr. Timothy Stenzel: Regarding...

(Daniel Marcus): That's in the E - that's within the context of the EUA but I'm asking vis-a-vis the 

notification pathway what's acceptable in addition to a high - in terms of 

distribution of the test in addition to high complexity CLIA labs.

Toby Lowe: Yes, so...

Dr. Timothy Stenzel: And let me...
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Toby Lowe: ...on their notification...

Dr. Timothy Stenzel: Toby let me...

Toby Lowe: Oh, go ahead Tim.

Dr. Timothy Stenzel: Yes let me start that question or that answer. So under notification, the test 

can be performed at high complexity lab. For those entities that are labs and 

have an LDT and they want to have their notification posted, we'll post it on the 

FDA Web site.

All kit manufacturers via the notification pathway do go on that list. It is my 

understanding that - but we would have to refer you to CMS on reimbursement 

but tests that show up on the notification list that perhaps aren't yet EUA 

authorized can still get reimbursed. And with that, I'll turn it over to Toby for 

filling in more details and/or correcting me.

Toby Lowe: No, thanks. So right so under notification as noted in the guidance there are - all 

of the tests that are being offered without or prior to EUA default to high 

complexity. And that's under the CLIA regulation. So because they're high 

complexity the only way that they can be used at the point of care is if that point 

of care site is covered by the laboratory’s high complexity or by a high 

complexity laboratory’s CLIA certificate, sorry about that.

So I think that gets to your second question of what the setting is where these 

tests can be performed while they're being offered under this policy. Does that -

is that correct? Is that what you're asking there?

(Daniel Marcus): That is what I'm asking. That does clear it up. One still question...
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Toby Lowe: Okay.

(Daniel Marcus): ...that I - not to hog the mic is so you guys are allowing for - maybe this is more 

of a CMS question or a CLIA question, you guys are allowing a high 

complexity to CLIA labs to do I guess off-site testing outside of the auspices of 

their own campus? So if they wanted to - if a high complexity lab wanted to 

be...

Toby Lowe: So...

(Daniel Marcus); ...able to do testing at a school or just totally outside of your domain?

Toby Lowe: That would be a CMS question. But what we're generally referring to here in 

the guidance is situations where - and this happens outside of the public health 

emergency. There may be situations within the hospital with the hospital 

laboratory does some of the testing at a near-patient site so at their bedside. But 

it would still fall under the laboratories certificate.

(Daniel Marcus): Okay, got it.

Toby Lowe: And so your - for your reimbursement question that really would be a CMS 

question.

(Daniel Marcus): Okay so I mean it's not really reimbursement more so than, you know, is it 

possible for a commercial manufacturer just outright sell a test during the 

notification pathway or is that a CMS question?

Toby Lowe: Oh yes. The notification policy applies to commercial manufactures 

distributing their test kits for testing. And that does - that is intended to mean 

the sale of your test. We're not saying that you should distribute them without...
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(Daniel Marcus): Okay that's what I wanted to get clarification on. So you guys answered my 

questions beautifully. I will stop hogging the mic. I appreciate your time

Dr. Timothy Stenzel: Operator do we have any other questions in the queue? We'll take our next...

Toby Lowe: Operator are you - is our operator still there? Do we have another question?

Irene Aihie: (Victor) are you on the line?

Toby Lowe: Sorry for the technical difficulties on today's call everyone. Thanks for your 

patience.

Irene Aihie: (Victor) is on the line.

Coordinator: (Un) my apologies. Okay, my mic was being odd. I apologize. We do have a 

question in queue and that question is from (Nermil Robbie). (Nermil) your line 

is now open.

(Nermil Robbie): Thank you. Thank you for this really informative session. I work with a clinical 

diagnostic laboratory that's outside the US that's using a US FDA EUA test, 

PCR test for COVID-19. So my question is, is the FDA accepting any user data 

regarding test performance because we are seeing between 10% and 20% 

invalid test results? And so would the FDA be happy to receive those data and if 

so how can I do that? Thank you.

Dr. Timothy Stenzel: Yes I'll start off. Toby may have something additional. So I think what 

you're talking about is if you're seeing subpar performance or issues with a test 

even though you might be using it outside the US are you allowed to report that 

to the US FDA? And yes absolutely. You can report that through the 
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MedWatch program on our FAQ page. You can also email our template e-mail 

address.

You can also report that to the company. We do require companies to record all 

complaints due at root cause determination and find out if it's verified. And in 

situations that require it, reporting those results to the US FDA even though 

they might occur outside the US as long as that test is also marketed in the US 

and could impact US healthcare. Toby is that pretty good?

Toby Lowe: Yes that sounds right to me.

(Nermil Robbie): Thank you very much and which template e-mail address should I send it to? 

CDRH?

Toby Lowe: It's CDRH-EUA-templates and...

((Crosstalk))

Toby Lowe: ...it should be on - I'm sorry @fda.hhs.gov. And it should be on the...

(Nermil Robbie): All right.

Toby Lowe: ...slides that are being displayed with the presentation too.

(Nermil Robbie): Thank you both very much.

Coordinator: Our next question comes from (Liba Sayed). Your line is open.

(Liba Sayed): Hi Tim. Hi Toby. Quick questions for you about the non-lab use template as we 

are running out of time here. First question is regarding the exclusion of 
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individuals who have experience with diagnostic home use tests like glucose 

monitoring tests. I'm assuming that applies only if your test is a finger prick 

type of non-lab use test as opposed to nasal swab. Is that correct?

Dr. Timothy Stenzel: No. In general, we want to assess untrained patients. And somebody who 

has routinely been performing testing on themselves at home will have an 

advantage over an untrained patient or consumer. And we're really trying to 

understand on the small number of samples that we're requiring in an EUA in 

that setting that we really understand the performance in a totally untrained user 

because that's the vast majority of potential users out there would be somebody 

who's never performed something like this before.

(Liba Sayed): Okay thanks. And then just really quickly I'm wondering in terms of the 

translation to Spanish of the quick reference information if the software user 

interface is not translated that that's the quick reference information is utilized 

in the studies if that is going to be acceptable for OTC claim?

Dr. Timothy Stenzel: I'm not sure I understand your question. You're talking about what language 

it has to be in because and what population is needed and comprehensive...

(Liba Sayed): Yes I think if you - I think there's...

((Crosstalk))

(Liba Sayed): ...a strong requirement to include your quick reference information in both 

English and Spanish for over the counterclaim is what the template suggests. 

And I'm asking if the quick reference information is translated. But, you know, 

the graphical user interface of the app, the step by step steps are still in English. 

And those are the tools that are utilized as part of the study if that will be 

adequate in terms of translation that you don't need to also translate your 
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graphical user interface in order to obtain that over the counter...

Dr. Timothy Stenzel: Into Spanish yes.

(Liba Sayed): Yes.

Dr. Timothy Stenzel: Yes and bare minimum we want to see things in English for the US 

population but to the extent you want to include language for other speakers 

within the US and population then we salute that. But we want to see at a 

minimum of performance with English language in the instructions and in the 

app. And it's up to you whether you want to go beyond that.

(Liba Sayed): Okay and then I do have others but I'm going to refrain from hogging the mic. 

I'll turn it over. Thank you so much.

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

(Kodamuti Venkat): Good afternoon. Can you hear me?

Dr. Timothy Stenzel: Yes.

(Kodamuti Venkat): Thank you for taking the question. My question is you have so many 

priority EUA things have come for serology, you know, they're 

semi-quantitative and quantitative tests have come. My question is you have so 

many pending qualitative serology tests so is there any timeline when the 

backlogs will be cleared? Are you getting so many additional support so that 

these pending qualitative serology tests can be looked into and then the decision 

will be given?

Dr. Timothy Stenzel: We're always looking at adding staff and we are hiring and we are looking 
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at ways to reduce the time it takes for us to evaluate. And we do appreciate 

those developers who work closely with us, you know, and as is our desire to 

see NCI testing to work with us if that's what we ask.

And you know and we are working really, really hard. And that's why we're so 

appreciative of the opportunity to have the notification pathway so that 

developers once notified can sell a market distribute their testing to US. So but 

getting to that EUA decision is also very important.

(Kodamuti Venkat): Actually we have submitted our test to NCI two months ago. We haven't 

heard anything from them yet. I think they are busy. And also main issue with 

us is it is in the notification list but many labs they insist it has to be an approved 

authorized test for them to procure. So they are interested. There is their 

independent validation but still, they are insisting on a EUA authorization for 

them to procure. So is there any way you can help?

Dr. Timothy Stenzel: Okay. So we would ask that that NCI is working very very hard. They do 

have a number of tests to test and they are working very hard and as fast as I 

think they can. And so you should have a contact at the FDA who can at least on 

a weekly basis who can give you an update on the status of things and have you 

direct your questions to that to that contact. And again there's a notified 

pathway. We understand what you're saying. It's - we're doing the very best we 

can here.

(Kodamuti Venkat): Thank you.

Dr. Timothy Stenzel: Next question.

Coordinator: Our final question comes from (Steve Skaggs). Your line is open.
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(Steve Skaggs): Hi. Thank you for taking my call. I just have a question about the fact sheet that 

is supposed to accompany the kits. Is there a template available? I haven't seen 

anything. Or is it just general information from the IFU that we put together for 

a more layman explanation of how to use the kit?

Dr. Timothy Stenzel: Yes. So we don't typically ask developers to weigh in on those fact sheets. 

They're pretty standard given a specific technology. They have gone -

undergone some revision over time to be more helpful. But that's something 

that the FDA drafts and provides during the process and then posts with each 

authorization.

(Steve Skagg): Great. Thank you for your help. I appreciate that.

((Crosstalk))

Dr. Timothy Stenzel: You're welcome. You too.

Coordinator: Now I'll now turn the call over to Irene Aihie for closing remarks.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and thoughtful 

questions. Today's presentation and transcripts will be made available on the 

CDRH Learn Web page at www.fda.gov/training/cdrhlearn by Tuesday, 

August 11. If you have additional questions about today's presentation please 

email cdrh-eua-template@fda.hhs.gov.

As always we appreciate your feedback. Following the conclusion of today's 

presentation please complete a short 13 question survey about your FDA 

CDRH Virtual Town Hall experience. The survey can be found at 

www.fda.gov/cdrhwebinar immediately following the conclusion of today's 

live Webinar. Again thank you for participating. This concludes today's 
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discussion.

Coordinator: Thank you for your participation in today's conference. You may now 

disconnect.

END