FDA CDRH

Moderator: Irene Aihie

3-25-20/3:00 pm ET

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FDA Virtual Town Hall Series –

Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

Moderator: Irene Aihie

March 25, 2020

3:00 pm ET

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

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

in a listen- only mode until the question- and-answer session of today's 

conference. At that time you may press Star-1 on your phone to ask a 

question. I would now like to turn the conference over to Irene Aihie. You 

may begin.

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

Welcome to the FDA's first in a series of virtual town hall meetings to help 

answer technical questions about the development and validation of tests for 

SARS-CoV2, and the updated policy on COVID-19 diagnostics policy for 

diagnostics test for coronavirus disease 2019 - during the public health 

emergency. Today, Elizabeth Hillebrenner, Associate Director for Scientific 

and Regulatory Programs in the Office of the Center Director and Timothy 

Stenzel, Director of the Office of In Vitro Diagnostics and Radiological 

Health in CDRH's Office of Product Evaluation and Quality -- both from 

CDRH -- will present an overview of the guidance. Following the brief 
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presentation, we will open the line for your questions related to the 

information provided during the presentation. Now I give you Elizabeth.

Elizabeth Hillebrenner: Thank you, Irene. And I wanted to thank all of the participants. At 

FDA, we really appreciate the great involvement from the community in 

working with us and working together to try to address this emergency to the 

best we are all able to as a team. And we do appreciate everyone's efforts and 

feel like we really are all in this together. 

So as background for this presentation, first wanted to mention that of course 

we issued a guidance first on February 29 that described a policy regarding

laboratories certified under CLIA to perform high complexity testing 

immediately using the tests they develop and validate while they go ahead and 

pursue an emergency use authorization. And this was in order to achieve more 

rapid testing capacity in the United States. This guidance was the subject of 

two previous webinars. 

And today we want to talk about the guidance that was updated on March 16, 

2020, which maintained that policy that we've already talked about with you 

and also introduces three additional policies. One is regarding states taking the 

responsibility for tests developed by certain labs in their state. Another is 

regarding manufacturers immediately distributing tests they validated while 

they pursue an EUA. And the last policy is regarding certain serology tests. 

Like the guidance that was issued on February 29, the March 16 update is 

issued immediately in effect. FDA determined that prior public participation 

for this guidance was not feasible or appropriate given the public health 

emergency, and therefore issued the guidance without prior public comment. 

That said, the guidance does remain subject to comment in accordance with 

our good guidance practices. 
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Next slide, please. So the first policy in the guidance is just maintaining the 

policy from February 29. This is in Section A of the updated guidance, and it 

includes recommendations regarding validating a newly developed SARS -

CoV2 test prior to clinical use, notifying FDA when clinical use of the 

validated test begins, and -- because this is a lab that it is certified under CLIA 

to perform high complexity testing that is developing and running their own 

text -- we're asking in this case that the lab confirms the first five positive and 

first five negative samples with an EUA authorized test. 

We're also asking that the test report include a statement to the effect that the 

test has been validated, but independent review by FDA is not yet complete.

We ask the lab to submit an EUA to FDA within 15 business days -- or three 

weeks -- of initiating testing. And here we're just talking about submitting that 

validation data that the lab said it had prior to initiating testing. So, three 

weeks to just put that into an email and send it to us. 

Elizabeth Hillebrenner: All right. And just to wrap up the discussion of the policy for high 

complexity labs that are running their own LDTs, we also in the guidance 

outlined some steps to take if any specimens fail confirmatory testing --those 

five positives and five negative done with an EUA test -- or if upon receipt of 

the validation, FDA is unable to authorize the EUA. 

Next slide, please. All right. Now, Section B of the new guidance outlines the 

new policy for state authorization of CLIA high complexity labs to perform 

testing without submitting an EUA to FDA. So this section includes 

recommendations for states or territories regarding optionally choosing to 

authorize labs within their state or territory to develop and perform a test for 

coronavirus under authority of its own state law, and under whatever process 

that state or territory establishes. 
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FDA will not be reviewing the process adopted by that state or territory, but 

we do expect that the oversight process would require laboratories to validate 

tests prior to use. FDA continues to believe that all tests need to be validated 

prior to clinical use. 

This guidance also includes recommendations that the state or territory notify 

FDA if they choose to use this flexibility to expedite testing in their state or 

territory. And we also encourage laboratories within such states or territories 

to notify us as well when they start clinical testing under this policy. 

Next slide, please. In Section C of the guidance we've outlined a new policy 

for commercial manufacture, development and distribution of tests prior to an

EUA submission. So this policy really parallels the February 29 policy for 

LDTs for manufacturers in this case. 

So again, the guidance includes recommendations regarding making sure the 

test is validated prior to clinical use, notifying FDA when distribution for 

clinical use of a validated test begins. In the case of the manufacturer, we ask 

that they post the instructions for use -- including a performance summary --

on their Web site, and indicate in the test report that the test has been validated 

but independent review by FDA is not yet complete. 

And again in the situation we would ask for an EUA submitted to FDA within 

15 business days of initiating distribution for clinical testing. 

Next slide, please. Thank you. In Section D of the guidance we have outlined 

a new policy for either commercial manufacture or a laboratory development 

and use of serology test without an EUA. So the recommendations here 

include of course validating the newly developed serology tests that detects
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antibodies to the coronavirus prior to clinical use, again, notifying FDA when 

clinical use of a validated test begins, and indicating in the test report 

information along the lines of the following. 

The test has not been reviewed by the FDA. Negative results do not rule out 

SARS-CoV2 infection, particularly in those who have been in contact with the 

virus. Follow-up testing with a molecular diagnostic should be considered to 

rule out infection in these individuals. Results from antibody testing should 

not be used as the sole basis to diagnose or exclude SARS-CoV2 infection or 

to inform infection status. Positive results may be due to past or present 

infection with non SARS-CoV2 coronavirus strains, such as a list of specific 

strains. 

Next slide, please. So to summarize these different policies and bring out 

some of the highlights, the first three policies -- the one for LDTs, the one for 

state authorizations and the one for manufacturers -- are for any technology -

molecular, antigen, antibody. The last policy for serology is specific to 

antibody test. In all cases we would expect tests to be validated prior to 

clinical use. That does not change. 

In all cases we expect some form of notification so that we can maintain an 

awareness of the testing that's going on for this emergency response. In the 

case of Policy A for labs who are developing and running their own test, the

notification would come from that lab. In the case of the state authorizations,

we're asking for notification from the state, and we encourage notification 

from the labs as well. 

In Policy C, we're looking for notification from the manufacturer who is 

distributing a validated test kit. And in Policy D for serology test we're 

looking for notification from the developer - be it a manufacture or high 
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complexity CLIA lab. The next column addresses whether or not an EUA 

from FDA is required. 

In the case of an LDT developing a test and running it in their lab or a 

manufacturer in Policy C developing a test and distributing it for clinical use,

we would like to see an EUA within three weeks of initiating testing or 

distribution. In the case of states taking responsibility (unintelligible) Policy B 

of LDTs in their state, an EUA to FDA is not required. 

Similarly in the case of serology test -- whether they're developed by a 

manufacturer for distribution or a high complexity lab -- if they meet the 

recommendations outlined in the guidance, specifically that they're validated 

and that the labeling includes the recommended statements -- then an EUA to 

FDA is also not required. For LDTs -- whether they are being offered under 

Policy A or Policy B under their state authorities -- these policies only apply 

to high complexity labs. 

In the case of the manufacturers who are distributing kids under Policy C or 

any developer who has a serology test under Policy D, if the tests are 

validated they could be used in a variety of different locations, including 

different types of clinical labs -- not necessarily only high complexity -- they 

could be used at the point of care under these policies provided the tests are

validated for such use. 

However they are not appropriate for home use within this policy. If a 

developer is interested in a home use test, we would ask that they work with 

us through the EUA process at this time. 

Next slide, please. The guidance also includes recommendations for test 

validation. The recommendations for molecular testing remain the same as 
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those outlined in the February 29 guidance, but we've also included additional 

recommendations to address antigen and antibody tests as well. 

So for all technologies, we would be looking for or recommend validation of 

clinical agreement and cross reactivity. For molecular and antigen tests, we 

recommend limit of detection studies. Fr molecular tests, we recommend 

inclusivity. For antigen tests, we recommended microbial interference studies. 

And for antibody tests we recommend class specificity. 

Next slide, please. So this slide is intended to just give you some information 

about how to send in notifications or an EUA if that is something that you are 

pursuing. For a notification -- whether it's from a state or a lab or a 

manufacturer -- we ask that you use the mailbox cdrh-euatemplatesfda.hhs.gov and follow the recommendations in the guidance for the 

minimal information that we're looking for here. 

And then for an EUA, we would ask that you submit that - normally an EUA, 

we would require submission to the document control center with certain 

requirements for how it's being submitted. Given the public health emergency 

that we are in right now, we have made a policy change just for this particular 

emergency, where we're accepting everything via email right now to oiroperations@fda.hhs.gov - we're trying to streamline things as much as 

possible for our submitters. 

We do need to see the form 3514 - the link is provided here. And we 

recommend the EUA template, for which another link is provided. 

Next slide, please. So I wanted to give you a status of where things stand as of 

yesterday evening So far in Policy A which have labs who have notified us 

they're running LDTs, we have 98 notifications. And those labs who have 
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agreed to us posting their names on the Web site are listed, and I have the 

links for you in the slide. We have four states who have notified us under 

Policy B. Again, those are listed in our FAQs online. 

In Policy C, we have four manufacturers to have notified us that they are 

distributing kits. Again, those are available in the FAQs. And for Policy D, we 

have 12 developers who have notified us that they are distributing or using 

serology test. We also have 16 EUA authorizations, and these numbers are 

growing every day. We have more notifications and authorizations daily, so I 

encourage you to monitor through our Web site links here. 

Next slide, please. I did want to take a moment to talk about modifications. So 

as noted in the March 16 guidance, we do not intend to object to the use of a 

test without a new or amended EUA if the test is validated using a bridging

study to an EUA authorized test. 

So a lab can take an authorized test -- whether it's CDC's or somebody else --

make some changes to it -- whether it's a new platform, a new component --

and if they do the appropriate bridging study or rely on somebody else who 

has done a bridging sorry for that change, then they do not need to come in 

with an EUA or notification. 

As noted in the guidance, we would like to see the validation data of that 

bridging study informally through an email to our CRH-EUA templates 

account. We would review that data, and if it does appear that it supports the 

modification, and if the laboratory or other entity who owns that data agrees to 

FDA sharing that information on our Web site, we would intend to update our 

Frequently Asked Questions site so that other labs can refer to that validation 

for their testing without having to conduct their own bridging study for the 

same modification. 
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So we're essentially looking to serve as a clearing house where if one entity is 

able to validate a particular tweak to an authorized test and they are willing to 

share that -- they don't have to share the raw data with the public, but if they're 

willing to allow others to leverage their findings -- we can serve as that 

clearing house, check that the data are good, and put it up on our Web site so 

that others can benefit and that everybody doesn't have to reinvent the wheel 

for every modification. 

So right now on our Frequently Asked Questions Web site we have a list of 

potential alternatives for swab, transport media, RNA extraction, PCR 

instruments, and validation and control materials. We urge you to share 

whatever data that you have with us so that we can keep adding to our 

Frequently Asked Questions and help everybody out. 

Next slide. The guidance also addresses manufacturer modifications to their 

own distributed kits. And here if a manufacturer has an EUA and they want to 

make a change, they can go ahead and implement that change when they send 

us the amendment for that change. They can go ahead and start implementing 

it right away while we do our review. 

Next slide, please. This is just a list of resources. Our Frequently Asked 

Questions page, I would really encourage folks to check that out. We are 

updating it almost daily with new information. So please continue to monitor 

that. Of course there's a link to the guidance document, the general EUA 

guidance document, and our novel coronavirus Web page. 

Next slide please. Okay, I seem to have lost my connection to WebEx so I -

actually it looks like we're now turning it over to questions. So operator, if 

you could open the lines for questions, please? 
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Irene Aihie: Operator, are you there?

Coordinator: Can you hear me?

Irene Aihie: Is this the operator?

Coordinator: Yes, this is the operator. Can you hear me?

Irene Aihie: Yes, we can hear you. Are you there?

Coordinator: Okay, thank you. Yes, thank you. If you'd like to ask a question on the phone,

please press Star-1. Please make sure your phone is unmuted and record your 

name to ask the question. Again that is Star-1 to ask a question. If you wish to 

withdraw your question, please press Star-2. One moment while we wait for 

questions to come in. Again, that is Star-1 to ask a question, unmute your 

phone and record your name. 

One moment please. Our first question comes from (Crystal Nguyen). You 

may go ahead.

(Crystal Nguyen): Oh, thank you so much thank you for doing this. My question is regarding the 

serology test. So is there a template - I know there's a template for the 

molecular test for the EUA submission. Is there a template for the serology 

test? Can you hear me?

Timothy Stenzel: Elizabeth, you may know that. Yes, I can hear you.

Elizabeth Hillebrenner: Yes, we are working on a template, but we do not have one 

available at this time. The idea was with this policy that most people would 
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likely choose this policy and not actually come in with an EUA. So we have 

been focusing our efforts elsewhere. But we have one in development. If you 

have a serology test that you believe needs to come through the EUA process,

I would encourage you to reach out through the template mailbox and we will 

be happy to help you.

(Crystal Nguyen): Okay, great. Thank you so much.

Timothy Stenzel: Yes, I would just add that most of the serology tests coming through now are 

IGGIGM, not for sole diagnosis, and a submission is not needed. 

(Crystal Nguyen): Right. So as long as the notification is done. Quick question - what about - so

the validation, can it be done by the manufacturer overseas? Like, let's say the 

manufacturer is in South Korea, and they have done the clinical study, can 

that be used?

Timothy Stenzel: Yes, it doesn't matter where the validation is done, just that a proper validation 

is done and that you notify the FDA and then you follow the other information 

in the guidance as far as labeling and the proper claims that you can make. 

(Crystal Nguyen): I see. And then what about the registration? Do you know from - like the 

medical devices registration that has to be also done?

Elizabeth Hillebrenner: Yes, if you notify us that you have a serology test, we will respond 

to you with information about registration and listing.

(Crystal Nguyen): Okay. Now that's for the distributor. How about the manufacturer in the other 

country? Do they - I assume that they have to go through the registration 

process and listing also? 
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Elizabeth Hillebrenner: Correct.

Timothy Stenzel: Once you - yes, correct. Once you notify us, we'll work with you and the 

manufacture to address all those concerns.

(Crystal Nguyen): Okay, got it. Thank you so much, guys. Thank you.

Coordinator: The next question comes from (Erica al Marati). You may go ahead.

(Erica al Marati): Thank you - thanks again, you guys, for doing this. My question also pertains 

to serology. Can you hear me? Hello?

Timothy Stenzel: Yes. 

(Erica al Marati): Oh, great, sorry. I heard a buzz. My question also pertains to serology. The 

notification states that the devices can be distributed to labs or health care 

providers. How widely is health care providers defined? Specifically, can it be 

sent directly to doctors' offices to test their patients if they do or don't have a 

CLIA certificate? How does that work?

Timothy Stenzel: Elizabeth, do you have...

Elizabeth Hillebrenner: This policy does not change any of the CLIA requirements in our 

guidance. So the developer would have to make sure they're meeting whatever 

the requirements are.

(Erica al Marati): Okay. So it sounds like you can sell to a doctor who's operating under a 

CLIA-waived or CLIA-moderate certificate, but not a doctor that is not. Is that 

how we're defining that?
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Timothy Stenzel: That sounds correct. If that really matters, send us a note at the templates 

email and we will follow up with (unintelligible).

(Erica al Marati): Yes, I asked that question specifically yesterday, but I understand you guys 

are up to your eyeballs with stuff. So if I don't hear back, I'll send another one. 

Thank you very much. 

Timothy Stenzel: Well - yes, that - I'll tell our team to be on the alert for that question. Thanks.

(Erica al Marati): Thank you very much.

Coordinator: Our next question comes from (Michael Messerman Smith). You may go 

ahead. 

(Michael Messerman Smith): Hi, thank you very much for doing what you're doing. I know you 

guys are really busy and I really appreciate expeditious and the updates that 

are coming through, and the clarity. My question is regarding the policy which 

was addressed in a previous question, but is there any guidance coming from 

the FDA to states regarding allowing CLIA waivers or activating - or some 

sort of process that is allowing the states to use ISO 17025 BSL-2 certified

labs to be activated to expand capacity?

Timothy Stenzel: I think you're talking about non-CLIA accredited labs? Is that correct?

(Michael Messerman Smith): Yes, that's the question that I have, is with these - would it be 

possible for these labs to be activated? We're talking to my - I'm in California,

and I work with an organization trying to network variety of CLIA/non-CLIA 

labs. And one of the circumstances that we might go to the state with is the 

procedures for activating non-CLIA labs or something like that. It's a work in 
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progress, but is that something that the FDA would be helping the states with 

or providing guidance to allow that to happen, given (unintelligible)...

Timothy Stenzel: Yes, it's actually not under the FDA's authority. It would be under CMS. And 

I know that a number of interested parties have approached CMS, so you may 

want to approach CMS with this question as well. My understanding is that 

there - that you could - and I can't speak for CMS, but one of the things you 

could ask for is if you have an existing laboratory CLIA license and you want 

to expand that to include additional personnel or space, you could potentially 

ask that question. I can't promise a response. 

And then if you are a facility that would like to become a CLIA lab, you can 

make an application for that, and ask if that can't be expedited. So again, I 

cannot speak for CMS, but those are at least two potential pathways you might 

pursue in discussions with them. Hopefully that's helpful. But again, this is not 

under the FDA's authority about where the testing is done. That is CMS. 

(Michael Messerman Smith): All right. Thank you very much.

Coordinator: Next call us from (Tom Sidebottom). You may go ahead.

(Tom Sidebottom): Thank you to the presenters and the information today. Very helpful, and 

appreciate the responsiveness and assistance from the email address and 

online. My question specifically is this. For foreign manufacturers that are 

registered and have an EUA or are developing an EUA, are the import 

processes aligned with getting the items through the courier hubs in a 

streamlined and efficient fashion?

Timothy Stenzel: Yes, we're working on that and aware of those issues. So if you encounter any 

problems, do send us an email at the templates email address and we will 
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endeavor to assist you. Elizabeth, do you have anything else to add? Not sure 

if Elizabeth's still on. She may have got kicked out. So hopefully that's 

helpful. But we are working through that with multiple parties now so that 

that's not an issue in getting into the United States. 

(Tom Sidebottom): Okay, great. Thank you very much. Appreciate you taking the time for the 

question today.

Timothy Stenzel: You're welcome.

Coordinator: Next question comes from (Ken Yao). You may go ahead.

(Ken Yao): Hi. Questions regarding - I'm working at a CLIA-certified lab and I would like 

to purchase the EUA kit and reagents to perform, but I don't have the

approved piece of equipment. So I do have other equipment can be used. Is it 

the same validation procedures, like reporting the first five or comparing the 

first five positive and first five negative with an EUA-approved test result?

Timothy Stenzel: So as Elizabeth explained, you're welcome to share the data the bridging study 

data, but if you're using an EUA authorized kit and you're validating it for a 

new piece of equipment, as long as everything validates well, go ahead and do 

that. 

Since it is - you are validating something new, it wouldn't hurt to go ahead 

and just confirm the first five positives and first five negatives with someone 

else who is already set up and using a completely EUA-authorized assay as a 

check. But I don't know - I wouldn't say right here and now that it's required. 

Yes, if you were developing your own LBT from scratch and doing it, that's 

clearly something that we want you to do. 
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But I would not require it for you using an EUA-authorized test. If you want 

to voluntarily share that validation data with us -- as Elizabeth mentioned --

we'll make that available to more folks if everything looks good. So hopefully 

that answers your question. Thank you. 

(Ken Yao): Thank you.

Coordinator: Next question comes from (Charlene Yao). You may go ahead. Hello? Please 

check your mute button. Okay, our next...

Timothy Stenzel: Hello?

Coordinator: Hello, is there anyone on this line?

Timothy Stenzel: This is just Tim.

Coordinator: Okay, Tim. Just a second, let me go to the next one, because this person's not 

answering us. So one moment please. Our next question comes from (Luiz 

Furlan). You may go ahead.

(Luiz Furlan): Yes, hello. I have a - first I want to thank you for doing this. It was very 

helpful. I want to ask about the serology test. Maybe I misunderstood, but I 

think if the person said earlier that the initial intent was for serology tests to 

not go through EUA, and that was the reason why there was no template. But 

I'm a bit confused because section D seems to be about that. 

Timothy Stenzel: Yes, so there's two different pathways for serology tests. One is just notify and 

don't submit an EUA - and that's for a test where you are just reporting the 

presence of IGG or IGM antibody. If you wish to make a claim as a sole 

diagnostic, then we would want you to come in to the EUA process. 
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So if you look for that section - and I'm not sure if I can pull it up right now quickly. There is a 

section where it's just notifying us. See if I can - I'm pulling that up now. Yes, 

so commercial manufacturing development distribution for use of a serology 

test without an EUA. It's Section D. So if you follow everything in Section D,

you do not need to come in with an EUA. 

(Luiz Furlan): Okay. And then - that's just CLIA, and I just use it in my lab. Is that it?

Timothy Stenzel: Well, if you are purchasing such a serology test that follows under D and then 

and that company has notified us and is following it, you are not required to 

do an EUA. It's just for the developers of this - or if you're a lab that's 

developing such a serology test, yes, and making just these claims, then you 

don't have to come in with an EUA.

(Luiz Furlan): Okay. And if I have a client who's a commercial manufacturer of such a 

serology test, is that the same - that seems to be what Section D is for.

Timothy Stenzel: Yes, if they're just going to claim the presence or absence of IGG and IGM for 

coronavirus -- for SARS-CoV2 -- then this is a pathway that they can use, and 

no template is needed.

(Luiz Furlan): Excellent, thank you. I have a small comment in closing. The electronic invite 

that I received did not have a link for the slides. So I did all this without 

slides. It was only phone number availability. So if you can perhaps provide 

more guidance in the next update of the FAQ for how to connect with full 

visuals for the next one of these, that would be great.

Timothy Stenzel: Oh, for the next town hall? Okay, yes, thank you.
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(Luiz Furlan): Thank you so much. 

Coordinator: Our next question comes from (Jackie Chou). You may go ahead.

(Jackie Chou): Hi. We are a commercial manufacturer for an IGM and IGG serologic test, 

and we plan to pursue the Policy D, which is notification path first .But can 

we upgrade it to Policy C -- which is the EUA path -- after we get the 

notification clear? Because the data is pretty much for - yes. 

Timothy Stenzel: Yes, if you want to follow - if you want to notify - if you're just claiming IGG 

and IGM detection and you're following the guidance under Section D, but 

you also want to get a formal EUA authorization, you can come through 

Policy C. Okay? And submit for EUA. 

(Jackie Chou): Okay. And then the start time - the 15 days completion date, is it from when 

we submit the first thing EUA? So we fill out the template and then we have 

15 days to send the data, but we already get all the data from the notification. 

So (unintelligible)...

Timothy Stenzel: If you want to follow Pathway C, you can simply notify us that you're 

following that pathway. Then you have 15 business days to submit your EUA

package. All the while, you can stay on the market as long as you follow the 

guidance on your Pathway C - which is you post your package insert along 

with your performance.

(Jackie Chou): Okay. This is very helpful. Thank you for everything that you do. Thanks.

Timothy Stenzel: You're welcome.

Coordinator: The next call comes from (Fasita). You may go ahead.
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(Fasita): Yes, thank you so much for your time. Again my question is also related to 

the serology tests that are being imported into the United States from outside. 

Are these products - can these products be imported easily, or will there be 

any questions if you have already sent the notification to the FDA? Do we 

need to show any evidence for getting the product inside?

Timothy Stenzel: Are you acting as an importer?

(Fasita): Yes, as an importer and distributor in the United States. 

Timothy Stenzel: Okay. Right. So if you encounter - once either you or the manufacturer

notifies us that you intend to market in the United States under Policy D, then 

we'll work with you to work through all those import issues.

(Fasita): Okay. And as soon as they send the notification, we are able to bring the 

product in to the United States and distribute?

Timothy Stenzel: Yes. But if there are additional notifications of border control and customs, 

then in order for them to be not held up, we'll work with you.

(Fasita): We have to work with you. Okay. So it's better for us to wait until we clear 

that up with you?

Timothy Stenzel: No. It's - you can go ahead and notify, and in real time, let's work through 

those issues. So you notify us, and then in your notification you can ask - and 

what additional do we need to do to ensure that the products can be imported 

into the United States?
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(Fasita): Okay. That's what we didn't do. We sent the notification, but we did not ask 

that question. Okay, so I will follow up with that question.

Timothy Stenzel: All right, thank you.

(Fasita): I have one more question, and I don't know if it's the right place to ask it, but

it has to do with the Medicare codes for this type of test. Would you have any 

guidance on that, or you know that?

Timothy Stenzel: No, that's again not in our purview. I would defer to CMS or one of the 

carriers on that. 

(Fasita): Okay, great. 

Timothy Stenzel: Or one of the professional societies.

(Fasita): CMS, okay. And just one last request - all the questions -- the very good 

questions asked by everyone -- will they be posted on the FAQs for 

everybody?

Timothy Stenzel: The questions on this call - this call will be transcribed, and so all the 

questions and answers will also be transcribed. But they will not be on the 

FAQ page. But through the mechanism to obtain the transcript from this call,

this will be provided you in writing, yes.

(Fasita): The answer I was looking for I guess is about the CLIA (unintelligible) 

several people asked, the plan for distributing this serology kit to the CLIA 

(unintelligible) labs, if it's allowed or not. That is really my specific question.
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Timothy Stenzel: If it's CLIA-waivable, then yes. But it does need to be a lab that can that's

accredited to handle CLIA-waived tests.

Coordinator: The next caller is (David Schutten). You may go ahead.

(David Schutten): Thank you. So under the guidance, we're not allowed to say that an IGG/IGM 

serological tests is CLIA-waived. But we've had questions from physicians 

asking -- who are capable of running CLIA-waived -- whether they are 

allowed to use the test. But it's not labeled as CLIA-waived, which a similar 

test would probably be labeled that way. Is there any advice to the physicians 

that we can give them to assure them that they're not going to be penalized for 

using these tests?

Timothy Stenzel: That is an absolutely great question, which I will take offline and bring to our 

experts. The CLIA-waived decisions are made in our office -- the Office of In 

Vitro Diagnostics at the FDA -- so we have the expertise to address that 

question. And I will ask that we can post this up on the FAQ page as soon as 

possible.

(David Schutten): Thank you.

Coordinator: Next question comes from (Peter van Hoering). You may go ahead.

(Peter van Hoering): Can you hear me?

Irene Aihie: Yes, we can hear you. 

(Peter van Hoering): Okay. So, this has been partially addressed but we're coming from a nonCLIA laboratory side and wondering about the activation side. I know right 

now the plan is to potentially purchase the Thermo Fisher kit for real-time 
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Moderator: Irene Aihie

3-25-20/3:00 pm ET

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PCR to do the clinical diagnostics testing for the virus. But as we're not a 

CLIA-certified laboratory, I was wondering - is there any discussion about 

potentially relaxing some of the requirements to help enable and activate the 

non-CLIA-accredited laboratories? 

Timothy Stenzel: So again, that is not something under the FDA's authority, but it's fully under 

CMS's authority. One pathway you can do -- if you can't work with another 

existing CLIA lab to have your operation run under their license by some 

mechanism -- is to actually apply for a CLIA license for your facility.

(Peter van Hoering): Okay. And what is the typical turnaround time to acquire the CLIA license 

and certification? Because I know time is of the essence.

Timothy Stenzel: It is. I'm under the impression that it's not long. But I would defer to CMS on 

what the turnaround time is here.

(Peter van Hoering): Okay. We'll reach out to them. Thank you.

Timothy Stenzel: Yes, you're welcome.

Coordinator: The next question comes from (Denise Ghast), and please limit to one 

question.

(Denise Ghast): Oh, well, I was going to make it a two part question does that count? I know 

the FDA has come out with multiple sample (unintelligible) and you keep 

adding to the list of things that could take place. Are we to assume that the 

FDA has done any kind of validation on those? Because I get the feeling when 

you say that some of those may not have good RNA return and if so when you 

say that you want five positive, five negative for that first group, are we to 
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Moderator: Irene Aihie

3-25-20/3:00 pm ET

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assume that that should be each specimen type, and using the different kinds 

of media and swabs?

Timothy Stenzel: Yes. First on the five and five question - we didn't really go down to that 

granularity. But it wouldn't hurt to - so we said first five positive and five 

negative. So I would follow that advice. And then - I mean, certainly if you 

had any questions about whether that applied to a more challenging specimen, 

you could do that as well. 

But I would assume that any new specimen type that is not listed as allowed 

on our FAQ page, that you would do a validation for, and then you would 

have validation data that would support the use of that sample type. I would 

say that we've tried to be very clear on the FAQ page as far as sample types, 

and where there is insufficient data to recommend something, we made that 

clear. 

But as of late on Monday night -- very late -- we updated it to say that while 

nasopharyngeal or NP swabs are still the preferred swab of choice, you can 

now do mid-turbinate and anterior nares -- or the lower nose -- in addition. 

And those appear to us to be -- looking at study data, which is not public yet,

but which United Health Group will hopefully publish very soon -- looks 

equivalent in performance to nasopharyngeal swabs. 

So we do make these decisions based on scientific - sound science and data 

when we have it, and the literature when the literature is appropriate.

(Denise Ghast): Okay, thank you. That really helps. 

Elizabeth Hillebrenner: I would add to that that the mid-turbinate and nares locations are 

for symptomatic patients. 
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Timothy Stenzel: Yes, thank you, Elizabeth. 

(Denise Ghast): Thank you. Appreciate it. And thank you for holding these town halls. Very 

helpful.

Coordinator: The next question comes from (Anthony Nguyen). Please limit yourself to one 

question. 

(Anthony Nguyen): Hello. Just a quick clarification question. So in California we have a lot of 

biotech labs in companies that are interested in developing these diagnostic 

tests. So how do we know which lab can go to the state and which can go to 

the FDA directly, given the guidance that was updated on March 16?

Timothy Stenzel: Well, you could come in through our templates email and ask if your state has 

that, but your state should provide that information to labs in the state. Well, 

they can provide that to labs in your state. We don't specify that. But if you 

have any questions about whether your state is doing that, just send an email 

to us at the templates email address and we'll let you know.

Elizabeth Hillebrenner: And we are posting the states that have notified us under Policy B . 

We are posting that in our FAQs. I believe so far it's New York, Washington 

state, Nevada and Maryland. But the link to that is in the presentation, and so 

you can monitor that Web page. And as more states notify us, we will add it to 

our FAQs so that everybody is clear about which states have opted into Policy 

B.

Coordinator: Thank you. That will be the end of the question and answers. Ms. Irene Aihie 

will now take over the call again. Thank you.
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Moderator: Irene Aihie

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Irene Aihie: Thank you. This is Irene Aihie, and 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, March 31. If you have additional questions about today's 

presentation, please email cdrh-eua-templates@fda.hhs.gov - and as always 

we appreciate your feedback.

Following the conclusion of today's presentation, please complete a short 13-

question survey about your FDA CDHR 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: You may now disconnect. Thank you all for participating, and have a 

wonderful rest of your day.

END