FDA Townhall

Moderator: Irene Aihie

05-27-20/12:15 pm ET

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FDA Virtual Town Hall Series - Immediately in Effect 

Guidance on Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

May 27, 2020

12:15 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participant lines are in 

a listen-only mode. After today's presentation, you will have the opportunity to 

ask questions and you may do so over the phone, by pressing star then 1 at that 

time. Today's conference call is being recorded. If you have any objections to 

this, please disconnect. And now, I would like to turn the call over to your host 

for today, Ms. Irene Aihie. Ms. 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 9th 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, Sara 

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

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

CDRH, will provide a brief update. Following opening remarks, we will open 

the line for your questions related to today's discussion. Now I give you 

Timothy.
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Timothy Stenzel: Welcome back to our virtual town hall meeting today. We will continue these 

calls through June and you will receive information about that in the very near 

future. I did want to take this opportunity to correct some of my remarks that I 

made last week. This has to do with the notification list for any notified (tests), 

but especially about the serology tests. So enforcement discretion and policies 

in our guidance do not make notified tests legally marketed. Enforcement 

discretion means that we do not intend to enforce the requirement. It does not 

waive the requirement.

So I perhaps should have correctly said tests on the notification list may market 

their device under the policy in the FDA policy for Coronavirus Disease 2019 

test. So I hope that is helpful in clarifying my remarks from last week. There are 

several updates and then we have a number of chat questions that we didn't get 

to last week that I'd like to go through. First up, on the FAQ page updates, it said 

29 notified serology tip developers were removed from our notification list for 

pathway (D).

There is a new list that's been added and it's under the question what test should 

no longer be distributed for COVID-19. Commercial or manufacturers listed 

below this question did provide notification to the FDA that they had validated 

and intended to distribute their serology tests for infection as set forth in section 

4.D of our policy. The FDA had previously included them on the Web site 

notification list of commercial manufacturers distributing through all of these 

test kids under their pharmacy, but they have now been removed from the 

notification list and placed on this list.

As noted in the guidance, if the EUA request is not submitted by a commercial 

manufacturer of serology tests within a reasonable period of time or if 

significant problems are identified with such a test that cannot be - had not been 

addressed in a timely manner, FDA intends to remove the manufacturer and test 
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from the notifications list. Some commercial manufacturers have voluntarily 

withdrawn their tests from notification and such tests are noted by an asterisk 

on this list.

All right. With that, I wanted to move into a couple of other brief FAQ updates. 

One is we added a new extraction option and that is the Beckman Extraction 

Reagent. Also, we've provided a notice on the RADx program. There is 

significant funding for developers of a rapid antigen, as well as molecular 

diagnostic tests. This applies to all developers and to just a new start-up 

developer. So even established companies who want to develop on the line that 

are noted in the (RADx) notification, we do want to make that widely available 

to all developers.

And with that, I will move onto the chat questions that we didn't get to last 

week. There was a question about are there any current saliva test applications 

under review? And is there any expectation that new saliva tests will be 

offered? Unfortunately, I cannot share any information on submissions under 

review. We can however, share that on May 21st we authorized the second test 

home specimencollection and this can be found on the EUA authorization Web 

page.

Can we develop a rapid detection assay use another rapid assay as a comparator 

method to demonstrate equivalence? At this time we are recommending that the 

developers use a high sensitivity molecular assay as a comparator. This is noted 

on a rapid antigen template on our Web site, as a recommendation.

So is there any role for point of care tests in asymptomatic pre-surgical 

patients? We are open to receiving data that we provide education on 

appropriateness for a test that can be promoted for this type of application. We 

have noted very clearly on our FAQ page that with an order for a test labs are 
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allowed to perform tests that EUA authorized tests for asymptomatic patients.

Another question is are the (NCI) panel samples available for manufacturers or 

developers to test their platforms? And at the moment, the testing is being 

performed at (NCI), but we are looking into how would you make the panel 

available for developers at their sites. For home collection kits, new questions, 

does the kit need to receive an EUA approval prior to using the kit or can an 

EUA be submitted and the kits used in parallel with EUA in the field? The 

notification policies in the guidance that permit clinical use prior to receiving 

EUA do not apply to that home collection kit, which must be authorized prior to 

use.

Next question - how long does it take to validate a lateral flow serology test? It 

depends on the data; validation is datadependent and not time dependent. Next 

question. With so many serology tests that we're required to submit now for 

EUA approval you can expect some notifications of these tests that start to be 

published on the FDA? EUAs will be posted once granted, which will happen 

as soon as possible. And so stay tuned and keep an eye on it.

What approval steps are necessary to begin selling nasal pharyngeal swabs? NP 

swabs are class 1 exempt and manufacturers should be aware of other 

requirements for class 1 exempt devices, such as adverse events reporting. For 

those manufacturers who have unconventional or alternative manufacturing 

needs, we encourage you to collaborate and validate your NP swabs through 

engagement with the NIH 3D Print exchange.

Next question. What's the position from FDA on use of current EUA (PCR) 

based test in asymptomatic and pre-symptomatic patients or for use to screen 

patients undergoing elective procedures? I did address this question earlier and 

as long as their healthcare professional is ordering the test and no plans are 
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being made for asymptomatic testing the FDA asks that a manufacturer using 

the EUA authorized test can go ahead and test those samples and report out 

those results. Let's see.

There's a question about when an EUA designation may end and when to move 

into the 510(k) pathway. And so the emergency declarations for public health

are made by the secretary and are unlikely to be terminated any time soon. We 

always do encourage developers to work towards a routine application. In the 

first case, this will be a de novo and then the second case will follow that. So we 

encourage these applications as soon as developers are ready and we're willing 

to work with them right now to convert these over to routine applications and 

routine authorizations.

We do have considerable discretion. Once tests begin to be authorized under 

this pathway to keep other EUA tests on the market, we look for the importance 

of those tests remaining on the market. And we do not foresee that need from 

going away anytime soon. Can the FDA address requirements for pooling 

samples from EUA? Have any EUAs been granted for approval samples? So 

we have not authorized EUA's approved samples. We know that there's a lot of 

interest in this as both reagents may be sometimes limited. And also as we ramp 

up testing as part of the get back to work and get back to school program. 

And so we are very open to pooling approaches. We would invite you to come 

in to discuss validation of these with us by emailing us at the template email 

address. One of the - a couple of the real critical functions here or - for 

consideration is what is the impact on detection on even low positive samples 

and what is the impact on the limited detection when you perform pooled 

testing?

So we do have thoughts that we can readily share with developers. Please reach 
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out. And we will be looking for opportunities to update our Web site with some 

information as soon as possible. Here's another question. Wasn't the FDA 

required to provide approval within 45 days of submission? Somebody has 

been waiting a while since studies have shown success. Why is there such a 

delay when other companies get authorized?

We cannot comment on specific submissions. We encourage the sponsor of this 

submission to reach out to a lead reviewer if they have any concerns. We do 

make it a priority to review applications that require EUA authorization prior to 

marketing or prior to offering that kit or that service. And so as long as 

somebody can offer something through one of the notified lists, that allows us 

to focus our resources on those that clearly require our EUA authorization.

I think that pretty much addresses the questions from last week that we didn't 

get to. So we can open it up for Q&A now. Thank you.

Coordinator: Thank you. If you would like to ask a question over the phone at this time, 

please unmute your phone and press star 1. You will be prompted to record your 

name and your name is needed to introduce your question. If at any time your 

question has been answered while waiting in the queue, you can remove your 

request by pressing star 2. Once again, that is star 1 for questions over the 

phone. And we do have our first question over the phone, from (Mark). Your 

line is open.

(Mark): Thank you. (ZOG) by (EYT) they were on the regulatory status submission 

pending a few weeks ago. Now if it's not in there now does that mean they're 

still pending or not pending? Where do they stand right now?

Timothy Stenzel: So are you talking about a test that was on a notified list and is no longer on that 

notified list?
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(Mark): Correct. It was submission pending two weeks ago and now it's not. But it's still 

on your list.

Timothy Stenzel: Can you check the new list for tests that can no longer be marketed and do you 

have a name for that?

(Mark): It was (ZOG) by (EYT). Yes.

Woman: Can you clarify which list you're looking at because we don't have a list that 

says pending submission. So I want to make sure that we know which list you're 

referring to.

(Mark): It's off the (360BX) dot com, the Coronavirus testing tracker.

Woman: Okay. That's not maintained by us and I think that is based on - probably based 

on self-reporting by the companies. The only lists that we maintain are on our 

Web site.

(Mark): Okay. Well, thank you.

Woman: Sure.

Coordinator: Thank you. The next question comes from (Ventak). Your line is open.

(Ventak): Hi. Good afternoon. Thanks for taking my question and thanks for all of the 

information that you have been giving. It's very useful. My question again is do 

we have a timeline when we can get the panel of samples that will be available 

for serology (update) developers? Because you have over 190 tests that are 

there and they - all of them are submitted to your (NCA) interagency panel.
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It is going to be really pushing so much pressure on - again in our resources on 

the particular team. Is it not really required to send the panel so that the 

developers can perform the test and give you the results for comparison? The 

test panel is really, really an essential thing. Can you please expedite and 

provide the panels to the developers? Thank you.

Timothy Stenzel: Okay. Yes, we're doing our best. So we'll continue to work hard and try to make 

that available. In the meantime, if a developer has notified us and has submitted 

an EUA, they can continue to offer that kit.

(Ventak): Thank you.

Coordinator: Thank you. The next question comes from (Daniel). Your line is open.

(Daniel): Hello? Hello? Can you hear me?

Timothy Stenzel: Hi, (Daniel). Yes.

(Daniel): Hey. How is it going? So I'm calling in regards to A2 viral science. So it's a 

serology test. So at first we have the EUA pending just like the other guy said. 

My question is where - our percentage for the (ZOG) test is about 93% how do 

you say, like the - what is the rating? When you take the test it's 93% positive, 

the serology test.

Timothy Stenzel: Okay.

(Daniel): So what is the - how do you guys go about that? What are you guys looking for 

in the ratings?
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Timothy Stenzel: I'm not exactly sure what you mean by ratings. But our expectation on 

performance, and you're talking about a serology test?

(Daniel): Yes.

Timothy Stenzel: So our expectations are that overall combined sensitivity of 90% is achieved or 

a positive percent agreement. And that for specificity or negative percent 

agreement that overall specificity is 95%. And then if there are reported out for 

isotypes for IGG we expect 90% sensitivity and for (IDM) we expect 70%. So...

(Daniel): Okay. So for the IGG and both IGM is 92% and 93%? So just going back to 

what you said a little bit earlier that if we had any information that could 

expedite, you know, you guys looking into a specific test, I would encourage 

you to please look at A2 bio science because we have a really good test study 

for it.

Timothy Stenzel: Okay. So our team of experts is working very hard. There are a lot of tests 

submitted and because of our guidance and the application list. And the 

requirements in that as far as submitting an EUA package. We do take quick 

looks at those packages. If there are any potential risks to - from the tests that 

may still be on the market, we will be addressing those with the developers as 

quickly as possible.

Otherwise, our reviewers are working hard and working through all of those. 

And as I said, as long as you're set up and met our conditions of the guidance 

including submission of the EUA package, you can continue to offer on that for 

you.

(Daniel): Okay. Then I also have one more question. The company is also working with 

Cedars-Sinai to - on a product named (Serolite). That's for (UAV) entry through 
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a catheter. Any updates on that? Any - have you guys looked at it or is that...

Timothy Stenzel: So I would urge you to contact us offline with your very specific question. And 

to address your question to one of our emails, , you can address that to our 

template email address. So any sort of specific - that kind of specific question 

we'll take offline. I'll just - when appropriate, I can talk generally about what 

our expectations are and what our processes are now for - leading to EUA 

authorization or another certain decision.

(Daniel): Thank you. Once again that's A2 bio science.

Coordinator: Thank you. The next question comes from (Vash Ladani). Your line is open.

(Vash Ladani): Hi Timothy. This is (Vash). Thank you so much, for taking my question and 

everything you and everyone at the agency is doing. My question is in regards 

to a model test that the company I work for are developing. And it's 

(unintelligible). We're wondering if, for development and validation we could 

use (then) blood samples from early 2019 for either negative control or 

cross-reactivity. Would that be an appropriate approach?

Timothy Stenzel: Yes. Potentially. We want to make those as streamlined and efficient as 

possible. However, I would really - we would really need to know the specifics 

of your technology - what markers you're looking at; what the purpose of it is; 

whether it's qualitative or quantitative. So what the stability of a bad sample is. 

So I would urge you rather than getting into specific details here, to reach out to 

our template address. If you haven't - if there isn't a timely response and timely 

means within 48 hours of sending that email, go ahead and ask them to connect 

you up with me.

But the team is working very hard. We're getting thousands and thousands of 
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emails and they're trying to do their best to address all questions in a timely 

manner.

(Vash Ladani): Understood. Thank you so much. I appreciate it. This helped very much.

Timothy Stenzel: You're welcome.

Coordinator: Thank you. The next question is from (Sai Maje). Your line is open.

(Sai Maje): Thanks again and thank you to all of the organizers for these town halls. I work 

at National Travel Health Institute and I was just wondering if there's any effort 

to expand access for - or availability and testing this platform for children and 

pregnant women?

Timothy Stenzel: So what kind of testing are you looking to expand into?

(Sai Maje): So both antigen as well as iron testing, specifically focusing on 

developmentally disordered children and children with intellectually 

disabilities. Both availability as well as commercial testing platform approval 

technically.

Timothy Stenzel: Right. So I don't know of any limitations in any of our assays with regards to 

patient age or demographic or other COVID related condition. So can you tell 

me a little bit more about essential access issues that you're experiencing so that 

we perhaps can better address your concern?

(Sai Maje): They haven't heard specifically about access issues, but this goes out for 

summer and potential reopening plans in discussion. I've been attending town 

halls and have not heard any questions in this regard. So I was wondering if 

there were any. That's why I called in.
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Timothy Stenzel: Yes. I mean get back to work and get back to school as potential efforts by their 

very nature, involve testing of a lot of people and of asymptomatic people, 

potentially what those entities employers and/or schools and other 

organizations decide to employ. As long as they're currently EUA authorized 

tests, as long as there's a healthcare provider order for such a test and is being 

monitored under their care, then that can apply broadly to institutions. I would 

just direct, you know, folks to their individual state's laws, rules and regulations 

to make sure they're complying with those.

But as long as an EUA authorized test is ordered by healthcare provider, the lab 

can definitely accept in our thoughts, these samples and tests and have those 

results. I mentioned earlier, pooling schemes are two things that in order to test 

the volume is needed. In some situations perhaps that pooling is a strategy. So 

you're really combining pooling testing and asymptomatic testing which we 

don't really have good understanding yet of what the asymptomatic carrier rate 

is and whether or not the virus is expressed at the same levels as in those with

symptoms.

And then we also expressed that for pooling we'd really like to chat with 

developers who use pooling to ensure that the performance is still going to be 

accurate in those situations. So this certainly is something on our minds and that 

we're having conversations about. So don't need to inquire if it's not important. 

I'm glad you brought this up. Hopefully, that addressed some of your questions.

(Sai Maje): Absolutely. Thank you so much.

Timothy Stenzel: You're welcome.

Coordinator: Thank you. Before I introduce the next question, please as a reminder, please 
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only ask one question and then you may queue up for another question if you 

wish. The next question is from (Mitch Andria). Your line is open.

(Mitch Andria): Hi there. Thanks for taking my call. Just to be clear, on the FDA.gov site what 

test should no longer be distributed, you went over that there's a list of 29 

manufacturers, correct, that are on that list?

Timothy Stenzel: Currently. Yes.

(Mitch Andria): Okay. So my direct question is this, and again I'm going to bring up the 

company's log, if they are not on this list then that's a positive thing meaning 

they can continue to distribute their test kits. Is that correct?

Timothy Stenzel: So any company that's on this, you know, no longer to be distributed list, should 

not be distributing.

(Mitch Andria): Right. But if they're not on the list then they can continue to distribute?

Toby Lowe: Are they on the notification list?

(Mitch Andria): No. They are not on the list.

Toby Lowe: So they're...

(Mitch Andria): I'm sorry.

Toby Lowe: ...list and that's where the manufacturers have notified us that they have 

validated their test and they're offering it under the policy outlined in Section 

4.D of this item.
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(Mitch Andria): Okay.

Toby Lowe: And tests that are listed on that list may be offered under those policies. If they 

were previously on that list and have now been moved to the new no longer to 

be distributed list, then they should not be distributed.

Mitch Andria: Okay. So if they're not on the do not disturb list, they still have to be on the 

original list -- which I'm sure they are. So that puts them in good standing. And 

that would also mean that they're still under pending submission for EAU.

Toby Lowe: So if they're on the notification list, then they may distribute under that policy. I 

don't, I'm not sure what you're referring to.

Mitch: ZOG Z-O-G. Are you allowed to comment on the list?

Toby Lowe: Yes. I mean it's a public list. I have it up right now. I did not see them on the list.

Mitch: Of which one?

((Crosstalk))

Mitch: On the notification list. They're not on actually either of the lists.

Toby Lowe: Correct.

Mitch: So however sometimes names are a little bit different and we do our best to get 

the names correct. So it could be listed under another name.

Toby Lowe: Yes.
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Mitch: Orient, how about orient gene like oriental orient gene?

Toby Lowe: I don't see them at first glance. I think if you want to email us at the EUA 

mailbox if you have questions about whether a certain test is listed or what 

name that might be listed under, we would be able to help you through there.

((Crosstalk))

Mitch: Okay.

Tim Stenzel: You can also contact the developer and ask them if they are on the list and have 

them show you whether they're on the list. So there's two lists that we're 

allowing serology kit developers to offer their tech. They're either on the EUA 

authorized list or they're on the notification list. And we have one list where if 

they're on that list they should no longer be distributed. If they're not on the 

notified list, and they're not on the EUA authorized list they should not be 

distributed either.

Mitch: Okay. I appreciate all your time. Thank you.

Tim Stenzel: Yes.

Coordinator: Thank you. The next question comes from (Shawn Nevas). Your line is open.

(Shawn Nevas): Thank you Dr. (Timothy) and the team there. I'm sure you know, you guys are 

overworked and under-resourced just like everybody else. And we really 

appreciate it. I have a question on virus transport media. We have developed 

one and we want to commercialize it. But I want to know if it is not for home 

collection, are we still required to get an EUA authorization?
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Tim Stenzel: So (Toby) is that a question addressed on the FAQs? If not I can address it.

Toby Lowe: Sorry, what was the specific situation?

(Shawn Nevas): The specific situation - go ahead, sorry.

((Crosstalk))

Tim Stenzel: I was going to say the developer of a VTM -- and I don't know if it's on our FAQ 

about what VTM manufacturers are required or recommended to do if they 

want to...

Toby Lowe: No. That is not on the FAQ. If you can send us an email to the EUA mailbox 

then we can get some more information to you that way.

(Shawn Nevas): Thank you.

Tim Stenzel: Yes, just email us a template. We do have advice that we can give to developers 

such as you. And we are looking at different ways that we can make 

information more publicly available. Thank you.

(Shawn Nevas): Okay. Thank you so much. Another question, if I may ask only one more 

question for saliva samples and protecting symptomatic and asymptomatic or 

pre-symptomatic people, what are your views on comparison of saliva sample 

collection to these (unintelligible) -- saliva being an easier way of collecting 

samples.

Tim Stenzel: Yes. I'm going to refer you to our template for molecular and/or direct antigens. 

We have updated the template with recommendations for saliva validation. If 

you're a manufacturer...
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(Shawn Nevas): Yes.

Tim Stenzel: ...you can notify us of an update, submit your validation and then be on the 

market while we review your submission. If you're a lab, you're not required to 

submit a EUA or saliva. Both of these are in circumstances where saliva is 

collected by a healthcare worker. If you're a lab, we have recommendations for 

saliva validation on our template. You can follow that. You're not required to 

submit an EUA.

If you want to offer this for home collection...

(Shawn Nevas): Yes.

Tim Stenzel: ... we do require an EUA authorization prior to offering that whether you are a 

lab or whether you are a kit manufacturer.

(Shawn Nevas): Okay. So if it is for home collection and you know, an EUA is needed, do we 

have to be connected if we only have the saliva collection part of it. Do we have 

to be connected to a lab that does the processing and have the whole line of 

custody work out before we submit for an EUA authorization? I was looking at 

(Everlywell) as an example.

Tim Stenzel: Yes. They're a great example.

(Shawn Nevas): Yes.

Tim Stenzel: So we do only authorize when an EUA authorized test is also authorized for use 

for that collection kit. And then each new assay will require a validation study 

to be added for that collection kit to be added to their authorization. So at a 
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minimum, developers of home collection kits do need to link up with at least 

one assay that's already EUA authorized or can be EUA authorized in parallel. 

And then we can give an EUA authorization to a home collection kit in concert

with a specific assay.

(Shawn Nevas): Yes.

Tim Stenzel: And then we will list, you know, what EUA tests are allowed to use that 

collection kit...

((Crosstalk))

(Shawn Nevas): Got it. Thank you so much.

Tim Stenzel: Thank you. Great question.

(Shawn Nevas): Thank you so much.

Tim Stenzel: Yes. Next question.

Coordinator: Thank you. The next question is from (Shaling Fan). Your line is open.

(Shaling Fan): Hi. My name is (Shaling). I'm a clinical lab director. Our infectious disease 

physicians have been pushing the lab to record the (CT) value of the PCR test. 

They claim it can help them to make clinical decisions. And I reject their 

request because this is not the standard practice. And also there are many things 

can affect the collection and CT count. So I would like to know your views on 

this issue. Thanks.

Tim Stenzel: Yes. Certainly, I've heard about this from others. So I think the context -- and 
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correct me if I'm wrong -- is that sometimes even when symptoms dissipate for 

patients, that they can stay in molecular test positive. And clinicians are trying 

to make decisions during these situations and are hoping that a very high CT 

which is a very low viral amount -- at least in that particular sample collection --

might help them determine what to do with that patient.

So I would say that you know, we still don't know very much about that. And 

then there are, you know, very clear challenges when collecting a respiratory 

specimen of any type. As to whether that sample stays equally well as the next 

time we sample even the same patient in some uniform way. So what can you 

really say about what the viral level is with one test used in this manner very 

unlike other viral load tests like for, you know, HIV, (COV), (HPV) and others 

that use a blood-based test system where obviously there's great clinical validity 

in those tests and those patients.

So I understand your concern. It's really challenging to think about how you 

might validate for that situation. So you know, I think you're an expert. You 

know your technology and the test that you're using at your lab. And I would 

certainly support you being comfortable what you do or don't do with the 

information you have at hand.

Is there something that you that think we could help with, with regard to this?

(Shaling Fan): So if we were going to move this forward, what type of validation do we need to

do recommended by you?

Tim Stenzel: Yes. So it's challenging sometimes and we're still learning so much.

(Shaling Fan): Yes.
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Tim Stenzel: And we're being asked to do things that are certainly have not been in common 

practice within other respiratory (sample types). So it's a bit of a challenge. And 

it almost does need some good data to tell us what it really might mean. 

Probably a conversation that will not go away -- that will be persistent because 

of the need to try to figure out what to do with some patients.

So I would urge you to reach out to us at our template email address and do ask 

for me (Sabim Ball) and let's get on the phone and let's chat a little bit more than 

we can right now okay?

(Shaling Fan): All right. Thank you so much.

Tim Stenzel: You're welcome.

Coordinator: Thank you. The next question comes from (Liz Friend). Your line is open.

Tim Stenzel: Hi, (Liz). You may be on mute.

(Liz Friend): Can you hear me?

Tim Stenzel: Now I can hear you.

(Liz Friend): Okay. I (unintelligible). I'm from base 10 genetics. I just have sort of a 

suggestion. You made a great distinction between the notifications and the 

(E-ray) the authorizations -- the difference between the two. And in general, 

one precedes the other.

So I wonder if the FDA might consider helping to in some way educate the 

public about that distinction because many of us would love to begin 

distributing tests for which we notify. But the general public -- or at least large 
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Page 21

organizations -- are hesitant without that actual authorization.

So I understand that you set it up in a two-step process. But is there any way that 

the FDA can improve the public education on we're still compliant even prior to 

issuance of the actual authorization and what your thoughts are on that.

Tim Stenzel: So first thing is we do make these lists public on our website.

(Liz Friend): Yes.

Tim Stenzel: And that can be offered up as evidence. We do have some explanation on the 

website as well as to what it means. And then prior to you being placed on a 

notification list all developers receive confirmation from us.

(Liz Friend): Yes.

Tim Stenzel: And that is also a document that can be used.

(Liz Friend): Yes.

Tim Stenzel: I will turn it over to (Toby). If she has any additional thoughts for this 

discussion.

Toby Lowe: Yes. I think it's also important to be clear that any of these tests that are being 

offered under the notification policy default to high complexity. 

(Liz Friend): Sure.

Toby Lowe: So I think, you know, most you know, general population individuals don't 

always know what test they're getting when they, you know, they know that 
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Page 22

they're getting a lab test but they don't necessarily, you know, pick a specific 

test from a specific lab. They're going to their health care provider and they're 

ordering the test for them.

But I think you know, we've done a fair amount of communication within the 

healthcare community I need policies. And we do also have some information 

available on our website for more of the general public. But the...

((Crosstalk))

(Liz Friend): We're looking - okay, we're looking to deal with employers -- helping 

employers. And serology testing is only one element of the program. So we're 

not using it in...

Toby Lowe: Right.

(Liz Friend): ... Isolation in any way. But it's large-scale employers you know -- those who 

have 10,000 plus employees -- and are looking to create, so. And we're a 

physician-owned company. So we've got a lot of medical backing behind us and 

all of that. But everybody is worried about if the FDA doesn't authorize it, you 

know, we can't use it yet.

So you know what? I use all the tools in describing and I really appreciate it and 

I understand how hard you guys are working. I'm just, you know, specifically 

for large employers or people looking to incorporate some sort of testing 

program, you know, just to make that distinction, notification is still compliant, 

you know. There's a difference between authorization and compliance, that 

notification is compliant. There's nothing legal about it or as long as they're 

listed on the list. I just...
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((Crosstalk))

Tim Stenzel: Yes.

(Liz Friend): ...a simple (unintelligible). Most of the employers...

Tim Stenzel: Yes.

(Liz Friend): ...dealt with are, we get one paragraph. Anything beyond one paragraph their 

eyes are rolling in the back of their heads and they're not listening.

((Crosstalk))

Tim Stenzel: So certainly we hear your concern. So a couple thoughts -- yes, we're working 

very hard to authorize as many as fast as possible as we can. One thing to pay 

attention to when looking at technology is if you need a point of care 

application or a moderately complex application, make sure the developer that 

you've been in contact with has submitted those studies to the agency...

(Liz Friend): Yes.

Tim Stenzel: ... before review. If they haven't done that, then they may get authorized but 

they may be limited to high or at most moderately complex (unintelligible).

(Liz Friend): We're partnering with a high complexity CLIA lab so.

Tim Stenzel: Okay. That's another option to get that available as soon as possible.

(Liz Friend): Yes.
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Page 24

((Crosstalk))

(Liz Friend): I was just offering a suggestion. Thank you very much.

Tim Stenzel: Yes. We're working hard. Thank you.

Coordinator: Thank you. The next question comes from (Catherine Copley). Your line is 

open.

(Catherine Copley): Hello. I'm looking to do a finger stick study so that we can use this at point 

of care facilities. And if we have a clinical validation that's already been done 

with serums, do we still need to validate the finger stick study with (PCR)?

((Crosstalk))

Tim Stenzel: So if you want point of care, is that what you said?

(Catherine Copley): Yes.

Tim Stenzel: So serum it's not something that's point-of-care. It's either whole blood through 

a venipuncture or whole blood through a finger stick. So those sample types do 

require validation and authorization along with some other point of care 

studies. Let's see. I believe in our serology template -- and (Toby) correct me 

but -- I believe we do offer up recommendations for those various applications.

(Catherine Copley): Okay.

Tim Stenzel: If you want to use any sort of alternate validation, we do encourage you to reach 

out to the template address where we can find out more details about your 

technology and what options you want to consider for alternate validation.
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(Catherine Copley): Okay. I was just wondering if since we already validated using a serum for 

the serology test and we want to move to finger stick if we could use that. 

(Unintelligible) haven't used the (PTR) test.

Tim Stenzel: Use the serum as the comparator?

(Catherine Copley): Yes.

Tim Stenzel: I would have to defer to our experts. I'm not going to say no it wouldn't be okay. 

I just would - I'd have to go back to the details of the templates. It should 

hopefully have some clarity around that. But that's certainly an option that we 

would entertain. So if that's not clearly stated in the templates, just send us an 

email to the template email address asking us specific questions.

(Catherine Copley): Okay, thank you.

Tim Stenzel: Yes.

Coordinator: Thank you. The next question is from (Avanti Savage). Your line is open.

(Avanti Savage): Hello. Hi. Thank you for taking my question. And I really appreciate the FDA 

answering our questions. So I wanted to know, get some guidance on the 

validation for test collection. And I know that FDA Mentioned in one of the 

previous town halls that there is be a home collection template and there's 

something in the works. So could you please give us an update on that or if 

there is any other requirement or specific guidance for test collection. Thank 

you.

Man: So health collection versus home collection are potentially two different things. 
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Page 26

So self collection as our nasal, saliva, and in the presence of a healthcare 

provider is something that for lab-developed tests can be...

(Avanti Savage): Yes.

Tim Stenzel: ...done already. For home collection, I forgot your question original question. 

Sorry.

(Avanti Savage): Sorry.

Tim Stenzel: Yes.

(Avanti Savage): It was just about a home collection template. Is there...

((Crosstalk))

(Avanti Savage): ...specific.

Tim Stenzel: Yes. Home collection, yes. So yes we understand there's huge interest in home 

collection. And first of all, sending an email to the template email address today 

we can get you our thoughts. But we know that there is a desire for this to be 

made more public. And we're working very hard to make that happen as soon as 

possible.

(Avanti Savage): Okay. Thank you.

Tim Stenzel: Yes.

Coordinator: Thank you. The next question comes from (Alex Vacilli). Your line is open.
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Page 27

(Alex Vacilli): Hi. Thank you for taking my call. And before I ask you in a Newsweek see a lot 

of counties, buy these rapid test kits. And they kind of sit on the shelves because 

they're waiting for approval. So there's a number of tests with a (CE) mark. Can 

you clarify if, you know, you recommend using tests with a CE mark until you 

can get the full EUA authorization?

Tim Stenzel: Yes, we wouldn't make that statement. It's my understanding that the CE mark 

for this kind of test is a self-certification and not by an agency or a notified body 

or other third-party. So you know, it's not something that for (CE) mark for the 

contest would be reviewed prior to making those kits commercially available. 

So you know, our FDA would not.

However, I will say that where there is a review -- a country of origin review --

any other countries that do review these and make horrible decisions we do 

incorporate those decisions into our review thinking for a given test what it has 

achieved so.

(Alex Vacilli): Okay.

Tim Stenzel: That's about as satisfying an answer as you could wish for. That's how we 

handle CE marking.

(Alex Vacilli): Okay. One more quick question.

((Crosstalk))

Toby Lowe: Also important to note that, you know, those tests if they've completed their 

validation can notify, and then they can offer under the notification policy while 

their EUA is under review.
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(Alex Vacilli): Okay.

Tim Stenzel: That is correct. But I think I heard that from folks who may be purchasing kits 

out there are waiting for EUA authorization. And again, we're working very 

hard to make those decisions and make those decisions public.

Coordinator: And our last question for today is from (Jackie Chan). Your line is open.

Jackie Chan Hello and thank you (unintelligible) last question. Thank you. My question is 

that I notice in all the EUA there is a waiver cost that we've all manufacturer of 

this (GMP) requirement and the quality system requirements. I'm just 

wondering why is FDA doing that. Wouldn't it be a risk to waive that 

requirement?

Tim Stenzel: So under the emergency declaration situation, in order to make as many tests 

and other devices available, we do make efficient use. We do not waive all 

requirements. And (Toby) can fill in the details. But we still do require some 

important elements such as complaint handling and (MDR) reporting that we 

believe is an important safety element to keep. And there are other provisions 

that we have or will have made requirements for that are above what we usually 

consider in an emergency situation.

But practically speaking, if we didn't allow some flexibility when it comes to 

those regulations and compliance with those regulations, we wouldn't be able to 

address some of the significant needs in an emergency such as this. (Toby) do 

you have anything else to add?

Toby Lowe: Yes, that's correct. It's part of the benefit-risk evaluation under the emergency. 

And as (Tim) said we are not waiving all requirements. We do consider which 

requirements may be appropriate to waive in this particular setting.
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Jackie Chan Okay. Thank you. Thank you again for everything, everyone at your agency 

does. Thank you.

Tim Stenzel: You're welcome. Thank you.

Coordinator: Now I will turn the call back over to Irene Aihie. Ms. Aihie, please go ahead.

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

thoughtful questions. Today's presentation and transcript will be made 

available on the CDRH Learn web page at www.fda.gov/training/cdrhlearn by 

Tuesday, June 2. 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 the 

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

discussion.

Coordinator: Thank you. All participants you may disconnect at this time. Speakers, please 

stand by.

END