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Virtual Town Hall Series - Immediately in Effect 

Guidance on Coronavirus (COVID-19) Diagnostic Tests 

Moderator: Irene Aihie 

June 3, 2020 

11:15 pm ET 

Coordinator: Welcome and thank you for standing by. My name is Amber and I will be your 

operator today. Today’s conference will be on listen-only until the question and 

answer session. At that time you may press Star 1 to ask a question. Today’s 

conference is being recorded. If you have any objections please disconnect at 

this time. I know like to turn the meeting over to your host Irene Aihie. You 

may begin. 

Irene Aihie: Thank you. Hello. I am Irene Aihie of CDRH's Office of Communications and 

Education. Welcome to the FDA 11th in a series of virtual town hall meetings to 

help answer technical questions about the development and validation of tests 

for SARS CV during the public health emergency. 

Today Timothy Stenzel, the Director of Office of In Vitro Diagnostics and 

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

Brenner, Associate Director for Medical Affairs and Toby Lowe, Associate 

Director in the Office of In Vitro Diagnostics and Radiological Health all from 

CDRH will provide a brief update. 
 

 

 

 

 

 

 

 

 

 

 

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Following 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. 

Timothy Stenzel: Good day. Thanks for joining us again today and apologies for the technical 

glitches. And we know that we'll have a number of folks probably joining over 

the course of this call. And we'll make sure that this is all resolved next week. 

There will be a transcript from this call for the folks who couldn’t join at the 

beginning. We can get updated and we endeavor to get those transcripts 

reviewed, edited for correction of the actual spoken word and out - back out to 

folks. 

So just a high-level overview we've now authorized 120 (one-two=zero 

diagnostic tests. We have also authorized 15 serology tests. When those 

serology tests have had testing performed at the National Cancer Institute as 

part of the Interagency Serology Testing Program that information while 

usually if not always be immediately available in the instructions for use 

section of the posted authorization for that serology test. 

And then as soon as we are able to, we will launch and link the product-specific 

report from the NCI testing. So be on the lookout for those. But once serology 

tests has been posted and is authorized check the ISU for NCI data. 

And then I also wanted to update that there are now 31 removed serology tests 

removed from the notified list. We have that removal is posted on our FAQ 

page. Next, I wanted to cover updates to the Abbott ID Now. Monday this week 

updates to the Abbott authorization ID NOW authorization were made. 
 

 

 

 

 

 

 

 

 

 

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Now formally as we previously announced negatives by the Abbott ID NOW 

tests are classified as presumed negative tests or negative results and as clinical 

situation warrants it is recommended that those negatives be reassessed to 

another molecular test. 

In addition in the letter of authorization that is posted on our Web site for the 

Abbott ID NOW, there is an additional condition that includes a requirement 

for a formal post-market study that's agreed-upon with the FDA. And the time 

period in which that has to be performed and reported back to the FDA is also 

listed in that updated letter of authorization. So the FDA will be monitoring this 

and any other potential situations closely. 

We always welcome input on performance of any of the tests that we’ve 

authorized or any other situations that you feel would be important for us to 

know about and we thank you in advance for that. With that, I will turn it over 

to Toby Lowe who has a brief announcement. 

Toby Lowe: All right, thanks, Tim. Thanks, everyone for joining us today. We wanted to 

plug a safety issue that's come up as we've discussed previously, I think on 

these town halls and we've included in our FAQ on our Web site there are 

certain types of transport media that are not compatible with certain testing 

platforms. When materials that contain one of these guanidinium thiocyanates 

interact with bleach the resulting chemical reaction produces dangerous 

cyanide gas. 

On our FAQs we have a warning about this specifically regarding the (Prime 

Store) MTM which contains guanidinium thiocyanate that it should not be used 

with a Hologic Panther or Panther Fusion System since those systems have a 

disinfecting step that involves bleach. 
 

 

 

 

 

 

 

 

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We’ve recently become aware that some transport media are being distributed 

without appropriate labeling which makes it difficult for laboratories to know 

which media they’re using and what the ingredients are. Because this is a big 

risk, we want to make sure that all labs are aware of this issue and we're 

working with manufacturers to correct it. We're also working on providing 

further communications to laboratories about this issue. 

So we want to make sure that labs are aware that the (Prime Store) MTM the 

Zymo DNA RNA Shield and the Spectrum Saliva Collection device, as well as 

any other transport media that contains guanidinium thiocyanate and similar 

chemicals, should not be used with the Hologic Panther or Panther Fusion 

System or with any other systems or laboratory processes that use bleach. 

If there are any questions about this or if you come across any issues with 

transport media or come across any media that is being sent your laboratory 

without appropriate labeling, we would appreciate you coming to FDA and 

notifying us about those issues. And you can do that through the normal 

Medwatch process and you can also email us at the CDRH EUA templates 

email address. 

Timothy Stenzel: Okay I think we're ready to open it up for questions. 

Irene Aihie: Operator we'll now take questions from our participants. 

Coordinator: Thank you. We'll now begin the question and answer session. If you’d like to 

ask a question please press star 1. You will be prompted to record your name. 

Please be sure to unmute your phone. Once again if you’d like to ask a question 

please press Star 1 and we'll pause for just a moment to allow those questions to 

start coming through. Our first question comes from (Val). Your line is open. 
 

 

 

 

 

 

 

 

 

 

 

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Val Hi Dr. Stenzel. I have a question for you and your colleagues. In regards - is 

there - sorry. I just (unintelligible) an FDA guidance in regards to a pathway for 

510K for serological assays? Here at (Boca By) we're supporting companies 

and what we’re doing is redoing collections of samples from COVID positive 

patients and want to see was there any particular time point that you could 

recommend as far as like getting patients who are acute all were through 

convalescence, were there specific time points whether it's 14 days posted from 

onset, 28 days and then 60 days post from onset? I wanted to get your feedback 

on that as well as what would be a considerable number in regards to number of 

subjects that would be significant in regards to these 510K case studies. 

Timothy Stenzel: Are you familiar with our Q sub-pre-sub constants? 

Val: Yes. 

Timothy Stenzel: Okay great. So this is a great question and a timely question. The first type of 

test that comes through for COVID or sorry, COVID-19 and SARS CV-2 that 

comes to us for our routine normal authorization will of course likely be a de 

novo and likely be classified as Class 2 with special controls. So that means the 

first one comes through the de novo, the subsequent ones would come through 

with 510K. 

We are going to follow our usual and routine manner in processing these when 

they are converted to a normal submission from (EUA) submission and include 

our normal expectations from performance evaluation all of the clinical and 

analytical studies and all the ancillary requirements of those submissions. 

We are recommending or we are suggesting I mean it's very wise to come in 

with a pre-sub or a Q sub especially in the early stages or in - for those who are 

coming in first. That is a process by which Q subs or a pre-submission process 
 

 

 

 

 

 

 

 

 

 

 

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and there's a link on our Web site that perhaps if it's not already on one of our 

related Web sites we can post it up there so that it’s really easy for developers to 

see this. 

So the process is first of all it’s not required but it is obviously probably a very 

wise thing to do because to just study or ask questions for this normal 

submission process. And then that will go into the experts on our team and we'll 

assess those questions or our protocols and provide very specific and timely 

feedback back to the developers. So I think even for you who are advising 

others and are trying to learn about this I think that's a useful way for you to 

approach us as well. 

But then we just use specific documented feedback that it's our practice to 

adhere to that once we’ve given written feedback back to a sponsor or 

somebody who comes in with a question you have that documented and 

established with us so that you can rely – you can have good assurance or 

expectation that you can rely on that information that we provide in a written 

form. 

Val: Thank you very much. I appreciate the reply. Thank you. 

Timothy Stenzel: You’re welcome. 

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

Susan Sharp: Hi. Thank you again, FDA, for everything that you’re doing in this time. It's 

very helpful to all of us. And I was just wondering if you could tell us and I 

know Tim you said early on the phone call today that the Abbott ID NOW 

should be reported out as a presumptive negative. Can you tell us where we can 

find that wording in the FDA FAQ? I was looking yesterday and could not find 
 

 

 

 

 

 

 

 

 

 

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it. Has that been added? 

Timothy Stenzel: So that is not in the FAQ it is in the Authorization Page. And since I didn’t 

specifically mention this particular test in my open now, I will answer about the 

specific test, but usually we don't. But that would be present on our FDA New 

Way Authorizations Page. 

If you go to the avid ID NOW document and you look at (lease) Testing 

Instructions For Use link you will have that updated instructions for use, 

intended use statement and any - and I believe it’s also in the limitations portion 

of that new ISU as well. 

Susan Sharp: Thank you. 

Timothy Stenzel: You’re welcome. 

Coordinator: And next we'll go to (Michael Campbell). Your line is open. 

Michael Campbell: Hi. Thank you. I was just wondering if you can give me an idea on the 

general timelines we can expect for reviews of the EUA submission? I 

understand from a previous town hall meeting that basically on receipt there's 

basically an intermediate for completeness review and in contact with the 

submitter. 

I've been submitted for four weeks now and I have not heard one word other 

than a reviewer has not been applied. As soon as we do that, we'll let you know. 

You know, it doesn’t really line up with an emergency if you ask me. If you 

could just give me some guidance so I understand what to expect in terms of 

timing that would be great. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Timothy Stenzel: So we have obviously received a large number of applications. 

Michael Campbell: Sure. 

Timothy Stenzel: And our policy is for developers to be able to notify us and then begin – if he 

doesn’t get a response from us that we’ve reviewed your notification and 

basically, it's accepting to that. And then you are allowed to go ahead and begin 

selling and distributing the test in the US. Because we have allowed for that we 

focused our review system on those that require the EUA authorizations prior to 

be able to come onto the market place. So that would include things like home 

collection and home testing. 

And other categories where an EUA is absolutely required. So if there is a 

particular reason why you were – you haven't – why it's been sort of urgent in 

the EUA authorization, please send an email to the template's email address and 

ask them to refer it to me, Timothy Stenzel, for review okay? 

Michael Campbell: Well I’ve been communicating directly with Toby for the last week or so 

specifically on this issue and it also - it still doesn’t seem to move forward. 

Sorry Toby but, you know? 

Toby Lowe: Yes, we understand. I think as, you know, as Tim just said we do have a large 

volume and we are trying to prioritize as much as possible. 

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

Margot Enright: Yes thank you. And this kind of follows-up with the question that was just 

asked. Last week you mentioned that the EUA submission reviews that have 

already been notified or are not prioritized over the new EUA submission. So is 

it possible that we can file the EUA submission and then after we file the EUA 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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can we file a notification so we can put it on the market immediately? 

Timothy Stenzel: So what type of test do you have just so I can make sure I’m giving you... 

((Crosstalk)) 

Margot Enright: It’s an antibody test, a serology test. 

Timothy Stenzel: A serology test. So serology test is covered under our current policy. You have 

- can notify us that you have validated the test. We are almost on a recent 

guidance update on this. You then have two weeks, ten business days to submit 

a validation package to stay compliant with that guidance. 

And then once you notify us though that you’ve completed validation and wish 

to begin distribution, we will review that notification and we will get back to 

you with documentation that assures you can begin distribution prior to EUA 

authorization. 

And that's the same for all serology kit manufacturers. And that repeats actually 

what we said before. So you are allowed to distribute after you’ve notified us. 

And we review that notification and give you feedback and then that you adhere 

to the rest of the guidance which requires... 

((Crosstalk)) 

Margot Enright: Is an possible if this is already filed - file the authorization that we can then 

notify you though in that... 

Toby Lowe: Yes. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Margot Enright: ...because I know that’s reverse order. 

Toby Lowe: Yes as long... 

Margot Enright: Is that possible? 

Toby Lowe: Yes, the order doesn’t matter as long as you have completed the appropriate 

validation and are following the policy under the guidance you can notify why 

or while we're reviewing the EUA. 

(Margot Enright): Okay great. Thank you. 

Timothy Stenzel: Yes, the order doesn’t matter. If you’ve already filed and you haven't notified 

you can still notify us. 

Margot Enright: Right, great. Thank you very much. 

Coordinator: And next we'll go to (Tim Hendrix). Your line is open. 

Tim Hendrix: Yes thank you. This is in that earlier question I think posed from (Mike) and 

just the one just now regarding the EUA and the serology testing and the 

authorizations. We understand that you can continue to promote the test as long 

as you follow the template in the submissions. 

But the challenge right now is the market and especially the CLIA abs are all 

under the impression now based on the May 4 policy that the FDA is coming 

out with formal EUA approvals and authorization. And so they're disregarding 

previous policies. 

Is there anything that you guys can do from your side to clarify this or make a 
 

 

 

 

 

 

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clarifying statement to the market because it’s extremely confusing now that 

the policy has changed multiple times allowing individuals to understand that if 

you’re taking a first come first serve basis and you're your prioritizing on your 

side some of these EUAs may take time before their release to market. Is there 

anything you can do on your side? 

Timothy Stenzel: Yes so, I’ll just make the statement of the policy. One change, the major change 

was we weren’t requiring EUA submissions for serology tests and now we are. 

We are still allowing the test to be distributed after notification which includes -

after notification which includes that we were saying that you were validated 

and the requirements of submitting that, that was stationed within ten days if 

you haven't already submitted that validation package. 

And I will say on this call that it will be recorded in the transcript that those tests 

can be distributed and used in the US after those developers name show up on 

our notification list on our Web site and after they receive a formal response 

from us following the request for notifications but they can also show to 

everyone who may wish to purchase those tests that are in high complexity labs 

so that they that – and then if there are any issues on any specific interactions 

we're happy to try to help out, just send us an email to the company's email. 

Yes, thank you. 

Coordinator: All right the next question comes from (Omar Habib). Your line is open. 

Omar Habib: Yes good afternoon. My question I’m going to switch gears a little bit. We are 

looking at pool PCR testing for asymptomatic individuals. And I understand 

I've contacted you by email. I understand that guidelines are forthcoming. I was 

wondering if you could provide an overview or preview for what those might 

be? And again it's primarily for asymptomatic individuals which we found to 

have a very low prevalence of positivity. Thank you. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Timothy Stenzel: So can you tell me whether you are a kit manufacturer or you have a 

laboratory-developed test and if you have notified us? 

Omar Habib: So I’m a CLIA medical director looking at implementing this across our 

market. And we have – we are using in our market different platforms of - so we 

have (unintelligible). We have Roche platforms and what have you all FDA 

approved tests. Obviously, this would be kind of an LDT or modification of 

those if you wanted to move forward. 

Timothy Stenzel: All right so you’re modifying some EUA offered test kit and from kit 

manufacturers for... 

Omar Habib: Yes... 

((Crosstalk)) 

Timothy Stenzel: ...and use in asymptomatic. 

Omar Habib: Correct. 

Timothy Stenzel: So our current asks for anybody who is wanting to claim asymptomatic use of 

their test that we would ask for a EUA for that use for any asymptomatic 

population. We have on our FAQ page stated very clearly that if it’s already a 

EUA authorized test and there’s a prescription order, a clinician order for a test 

that happens to be from an asymptomatic situation that we think that it’s okay 

for the labs to process that sample and report out that result. However, if there is 

a claim about performance and asymptomatic individuals, we – our current 

thinking is that we fire an EUA for that. 
 

 

 

 

 

 

 

 

 

 

 

 

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When it comes to pooling, we are looking at the situation very closely. For our – 

we are going to have some recommendations coming up hopefully in the very 

near future on validation for pooling to provide some more granularity. 

The bottom line that we’re interested in is accurate testing even in the pooling 

situation. We would want that all either low positive patients who get pooled, 

the samples get pooled by one of a number of potential schemes are not missed 

in the pooling of samples. 

And then as you go forward in the validation process you test that that is the 

case with at least significant - a minimum number of samples that you know 

that you have good assurance that you’re getting accurate testing and you’re not 

having false negatives in a pooling situation within some statistical margin. 

And so those are kind of some of the details that we're working on to be able to 

provide to the community. Of course our current – and so we're working on that 

as we speak and we hope that gets out in a short amount of time. And I know 

that we’ve had a number of inquiries on this and we're trying to do our best to 

ensure that accurate testing is able to take place. 

We know that there is a number of folks that are interested in this and we have 

engaged in some dialogue with folks about, you know, how they go about 

validating this and being able to have a EUA authorization for it. So that’s 

probably the most I can say all right today. But we – this is a very important 

topic and we are working on this very hard and hope to have great clarity and 

more clarity about what our recommendations are in the very near future. 

Omar Habib: Thank you. 

Timothy Stenzel: I’ll ask for patience, thank you. 
 

 

 

 

 

 

 

 

 

 

 

 

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Coordinator: Our next question comes from Symphony - (Cynthia Flynn), excuse me. Your 

line is open. 

Cynthia Flynn: Hi. Thank you very much for the informative calls again. My concern is with 

antigen testing vis-a-vis the presumptive negative results for the Abbott ID 

NOW. Why aren’t we resulting any kind of inefficient testing with the same 

presumptive negative for results since it will have probably a similar, you 

know, positive or negative predictive value? 

Timothy Stenzel: Yes actually OUR direct antigen test if they are below the expectation for a 

molecular test we'll have and do have the same language in the ISU. if you look 

to the ISU in the direct antigen test that they've authorized it is the presumed 

negative language is there. 

Cynthia Flynn: Oh okay. I didn’t see that. 

Timothy Stenzel: And so our expectation is that for any test that directly detects virus whether it 

be protein or nucleic acids that if it’s below the expectation for a molecular test 

which we set the bar at 95% for a comparison to another molecular test if it’s 

below that level our current thinking is that it’s best to be a presumed negative. 

And when we authorize our tests, we will ensure that that language is in the 

instructions for use and that it's clear to all who might consider using that test. 

And as we did with the Abbott ID NOW it’s already been distributed and we 

updated for public health purposes we will announce it in formats like this that 

we have updated it that it was also a press release but this sort of updates to the 

Abbott ID NOW with - was going to be forthcoming. 

But yes anytime that a direct detection assay is below the performance we 
 

 

 

 

 

 

 

 

 

 

 

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expect say of a molecular assay that this presumed negative language we plan 

on having in the instructions for use in any authorization. And we also have in 

mind and we set this very clearly for the direct antigen test in the template that 

those direct antigen tests are required to have at least 80% sensitivity relative to 

a high-sensitivity molecular test. So that’s sort of the bins that these things fall 

in and how we label them. So thanks for asking. 

Cynthia Flynn: Okay good. 

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

Howard Urnivich: Hi. Thank you very much for this town hall. My question is where would I find 

information related to developing a laboratory-developed test using 

next-generation sequencing? 

Tim: That's a great question. We know that that technology is kind of forward and 

that it's going to be a tremendous help in this battle because we will be able to 

— you will be able to - presumably you'll share it with others. Just note whether 

the sample positive or negative for SARS-CoV-2 but also the sequence 

information instead ends up being important. 

And we would urge anybody who is collecting sequence information from 

SARS-CoV-2 we put this in the typical areas so that developers included to 

survey the sequence information and keep track of the mutations just in case 

those mutations might occur in (unintelligible) and the (unintelligible). 

So the recommendations are likely to be very similar to the current molecular 

recommendation for (LDT). We expect that the performance be established on 

actual patient sample that the performance being very high, at least 95% 

(sensitivity). 
 

 

 

 

 

 

 

 

 

 

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We're not sure that's the developers but if you're interested in that shoot it to — 

and developers necessarily have to go into extreme detail elevation of the 

sequence. And likely will have authorization around the liability of their 

sequence. 

We see this technology as being able to provide an accurate positive/negative 

result for SARS-CoV-2 and in addition provide sequence information as 

wanted and desired by those who run the testing or who order the testing. But 

better expectations for the performance would be no less than the net for any 

other molecular test and for our molecular template for (LDT) it's a really great 

place to start. If you see anything missing and other questions about what's the 

rare opportunity email, I sent a template email address. 

But we are absolutely seeing developers interested in this area and as required 

or as helpful we will update the molecular template for MDS sequencing. As 

we know the large backing can be done. Hyperlinked sequencing can be done 

and in addition to the other badges that I mentioned earlier. 

Howard Urnivich: Can I - thank you very much. I have a follow-up. 

Tim: Sure. 

Howard Urnivich: Good, that's very useful and what we're doing is we're collecting two packaging 

tubes for patient and we're using one for discovery. The question is that the 

(unintelligible) will be frozen and not alive. Is there a format by which we can 

use that kind of collection system and then I guess what I'm hearing is we 

should probably also have a perspective study also? So we would do the 

retrospective with the samples we're collecting now and submit that data. And 

then we are wondering how many we have to do in a prospective of 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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environment that would meet all of the requirements. 

Tim: So I — what is the sample type that you're going to be looking at? 

Howard Urnivich: What we're trying to accomplish is we're taking packaging tubes so that we can 

extract total RNA then we sequence everything. And then with our pipeline is 

we would like to separate out all the COVID sequences as you mentioned but 

also if there's any co-infection going on if there's a micro plasmin prevent 

(unintelligible) there's something that needs to be flagged. 

We should do that all in one sequencing run so that's really the objective we're 

trying to meet here to see if we could add further clinical utility. If we're going 

to sequence the RNA we might as well just sequence everything and see what's 

in there. 

Tim: So you're putting respiratory specimens into the packaging tubes. 

Howard Urnivich: We're putting — I'm sorry. We're putting blood so we're collecting whole blood 

and we're finding that the preliminary data in another viral study is that we can 

find fragments of the virus infection in the blood, even though there isn't a 

(unintelligible). We are finding that there are biomarkers associated with the 

presumptive viral infection. 

Tim: Yes. So just as a — we have not authorized blood as a sample type before. 

Howard Urnivich: Okay. 

Tim: And I was referring to typical respiratory specimens. And so we would like to 

see prior to you launching this tested data on blood and get the specific 

authorization out. We also want to (test) the respiratory samples for (MDS) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(and) follow the typical notification pathway for (LDT) but (also) we want to 

make sure that there's accuracy on the blood. 

We have not authorized a blood base (NGS) So this would be something that 

we work through together to make sure that the proper validation is done so that 

we know the accurate testing is done in particular (pitfalls) are prevented. And 

our expectation for this kind of test would be that it would give 95% positive 

agreement with another molecular test that's been (authorized). 

Howard Urnivich: Excellent. We are collecting also respiratory samples too to do exactly that and 

then present the data to you. 

Tim: Right. And (along with) the sample (and the) test that you're running with those 

respiratory samples is (compared to an) authorized test. 

Howard Urnivich: Correct. 

Tim: And you can use that at a more (unintelligible). 

Howard Urnivich: Thank you very much. 

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

Kimberly Bunker: Hello. Thank you. So my question is about the 31 serology tests that can no 

longer be distributed. If a clear (unintelligible) lab had already purchased that 

test that ended up on that list and validated it, can they still perform serology 

tests using that test and simply not purchased (unintelligible) from that 

manufacturer? 

Tim: Yes. Well you should not be able to purchase anymore once they show up on 
 

 

 

 

 

 

 

 

 

 

 

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the (unauthorized) list. If you do — if anybody does, we would like to hear 

about it because that's on the — it's not intended. And you do put coming in 

from outside the country we do stop it at the border and having import alert to 

the border. 

So you know, it's probably best in a situation that you're in to (send an email) or 

somebody else on our team to know which test that you're using and we'd have 

a brief conversation about what validation did. And I don't know (if) we can 

you but specific advice and you're welcome to send an email to a template email 

address. 

And I — in these situations I am currently getting involved in the discussions 

and we've had these discussions already so I'm happy to engage with you on 

this. Right now we're kicking on a case by case basis providing the targeted 

specific advice because sometimes we know more than an email about a 

particular case, okay? 

Kimberly Bunker: Okay. Thank you. 

Tim: All right. 

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

Steve Skanks: Hello, good afternoon. Thanks for taking my call. I have a specific question. If 

one facility receives a EUA in our company, receives a EUA would it be 

acceptable for another manufacturing facility given the apparent need for tests 

in the marketplace to submit a separate EUA and manufacturer and 

(unintelligible) facility as well? 

Tim: So given the manufacturer has EUA authorization can expand the number of 
 

 

 

 

 

 

 

 

 

 

 

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manufacturers but (hasn’t) come in for a new EUA. And we may have — I 

would ask that you notify us that you're doing that so that we have it for our 

records and if you want to update the authorization with additional 

manufacturing codes you can do that. But there's no prohibition for a 

manufacturer (that) has a EUA to add additional manufacturing sites (where it) 

is fully authorized and there's fairly a need to expand the testing availability. 

Steve Skanks: Okay great. Thank you, appreciate your help. 

Toby Lowe: Just to expand a little bit on what (Tim) said what would be best would be to 

reach out to your lead reviewer on your EUA to check on what additional 

information they would need for the second manufacturing (site) and whether 

they're already (looking into) their EUA authorization about your 

manufacturing specifically so that we could update the authorization as needed. 

Steve Skanks: Great. Thank you for your additional information. I appreciate it. 

Coordinator: Okay. Next, we'll go to (unintelligible). Your line is open. (Unintelligible) you 

may want to check your mute button. Thank you. 

Man: Okay, yes. Can you hear me now? 

Coordinator: Yes. 

Man: Okay. So thank you for taking my call and I have question-related to the 

clarification that have been made. As I look at it as on today and the 6-2 on the 

website there are 203 tests that have been in our (unintelligible) manufacturer 

on commercial and that have been modified and that are 4D for serology tests, 

of which 15 they got the authorization. So if I have understood from the 

(unintelligible) you went through earlier for a practical purpose on these 203 
 

 

 

 

 

 

 

 

 

 

 

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manufacturers they can sell the product because they have notified and they're 

in the list. 

On May 23 the FDA — the CDC has given the interim guidelines 

(unintelligible) COVID-19 serology testing in that that accommodation site 

(unintelligible) so they mentioned the (unintelligible). It is mentioned here 

serological methods that have evidently (unintelligible) authorization 

(unintelligible) and clinical use since their test (unintelligible) data has been 

viewed by FDA. 

So then we wanted to do our tests through some lab that say your test is not 

authorized even though we are (unintelligible) our test and our name is there on 

the notified list. But (unintelligible) that have gotten the authorization at least 

they (unintelligible) the customers. They think these are the best that they can 

really use other than second (unintelligible). 

They have to get the (unintelligible) that only they can use and that I think you 

already mentioned that is not the case. Is it possible to clarify (unintelligible) 

some notification is given and even the interim guidelines of CDC can clarify 

these things (unintelligible) get some level of acceptance in the community? 

Tim: Earlier on this call we addressed this question. We have obviously seen 

challenges with the number of serology tests and some practices by a 

number of serology tests. 

We are working through the EUA authorizations as best as we can because of 

the many issues that have been seen. It's important that the EUA authorization 

is done properly, that we properly review the data that we need to make and 

assess on tests and only authorize those tests. Those tests that are on our notified 

list can be (put) in that formal position and (then) continues that. And that's 
 

 

 

 

 

 

 

 

 

 

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pretty much what we're trying to do. 

Man: Thank you. 

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

Annie Bell: Hello, thanks. I just had a pre-EUA that was converted to a EUA. So it was a 

pre-EUA for about four weeks and now we're about a week into the EUA status. 

I know FDA is working as best as possible but I was just wondering in light of 

this conversion what is the timeline we can expect to hear from the lead 

reviewers. So we've also been assigned a lead reviewer. I was wondering if you 

have any comments or insight on the timeline once assigned a lead reviewer. 

Tim: I don't know the specific instance of your application. Usually the conversion is 

from a pre-EUA to a EUA happens when there's enough information and data in 

the package that (we) can begin to finish a final review of the data. 

These are entirely dependent on the submission and if there any potential issues 

— if there any potential issues that need to be worked through. But your lead 

reviewer is the best source in all cases once you have been assigned a lead 

reviewer on timing and on the particular issues that are likely coming up in your 

application (to) close things down. 

We ask that our reviewers be transparent with our developers in the situation 

but I don't know the specifics of your (particular) lead reviewers you keep 

contact and supervise on all (related) information for this. 

Annie Bell: Okay thanks. 

Coordinator: I'd now like to turn the call back over to Irene Aihie. Thank you. 
 

 

 

 

 

 

 

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

thoughtful questions. Please remember that today's presentation and transcripts 

will be available on the CDRH Learn Webpage at 

www.fda.gov/training/cdrhlearn by Tuesday, June 9th. 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 and this concludes today's 

discussion. 

Coordinator: Thank you. And once again that concludes today's conference. Thank you for 

participating. You may now disconnect. 

END