FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

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FDA Virtual Town Hall Series #2–

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

Moderator: Irene Aihie

April 1, 2020

3:00 pm ET

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

listen-only mode until the question and answer session of today’s conference. 

At that time you may press Star then the Number 1 on your phone to ask a 

question. I would like to inform all parties that today’s conference is being 

recorded. If you have any objections you may disconnect at this time. I would 

now like to turn the conference over to Irene Aihie. Thank you, you may 

begin.

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

Welcome to the FDA’s second in a series of virtual town hall meetings to help 

answer technical questions about the development and validation of test for 

SARS COV-2 and the updated policy on COVID-19 diagnostics policy for 

diagnostics test for coronavirus disease 2019 during the public health 

emergency.

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

Radiological Health in CDRH’s Office of Product Evaluation and Quality will 

present an overview of the guidance. Following the brief presentation we will 
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open the line for your questions related to information provided during 

today’s presentation. Now I give you Timothy.

Timothy Stenzel: Hello and welcome to our ongoing series of town hall meetings. We intend to 

do these weekly at this time until we’ve addressed all questions which may be 

a while. I am only going to introduce some brief remarks today. The guidance 

of 16th of March is available. I can address questions that are specific to that. 

We did cover it in detail last week.

I do want to point out a couple of things though that are of importance. First 

of all please continue to check out our Frequently Asked Questions page at the 

FDA. We update these regularly. We do send out notices when these updates 

occur and so we try to alert people that way. But I would save the tab and 

check it frequently. As these updates get more and more it is hard a little bit to 

track, you know, where those updates occur. So I will in these weekly 

addresses I will briefly point to where the updates are and when helpful I will 

give a little bit more detail.

So since last week there are updates to what laboratories are offering testing 

under Pathway A. Also there is an update to which states have chosen to 

authorize laboratories under Policy B. Also there are updates on what 

commercial manufacturers are distributing test kits under Policy C prior to 

submission. And then there’s also an update to what serology assays are being 

offered under the policy in Policy D.

There’s also an update on how we go about authorizing and stating when there 

is a point of care or near patient device. I did want to read through this 

because we get a lot of questions about that and have received a number of

questions about that. And then I want to finish up after that with a discussion 

on serology testing and then we can jump into questions and answers.
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“So under this when FDA authorize - authorizes a SARS CV test for use at the 

point of care does that mean it is CLEA waived?” That’s the FAQ question. 

The answer is the FDA does not CLEA categorize tests authorized under 

EUA. Instead the settings in which an EUA authorized test may be used are 

described in the Letter of Authorization. This Letter of Authorization by the 

way is available on our EUA authorization Web site under each test 

developer.

We note that the terms “Patient care settings outside of the clinical laboratory 

environment,” “near patient testing,” then “point of care,” in the UAs policy 

for diagnostic test for coronavirus and are generally - and generally refer to 

settings that are equipped with the instrumentation as needed and 

appropriately trained personnel necessary to perform the test and may include 

settings such as hospitals, physician offices, urgent care outreach clinics and 

temporary patient care settings. These terms generally do not apply to home 

specimen collection or at home testing unless otherwise specified.

Okay, I would like to say something about serology. And these are typically 

the serology tests that are listed under Policy D on our Frequently Asked 

Question page. These are typically rapid finger stick tests for IgG and IgM

and IgM antibodies. The FDA we recognize that these types of devices have a 

critical place in the fight against coronavirus. These tests results should not be 

used alone to make a diagnosis but are helpful in identifying who may have 

already been infected and their immune status response.

The FDA’s diagnostics policy allows these tests to be used, and I have a 

quote, without FDA authorization as long as these tests are labeled 

appropriately, including a statement that they cannot be used as the sole basis 

for diagnosis or exclusion of infection. Results should be obtained and used in 
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complication with the healthcare provider. No at-home serology test are 

exempt meaning they need authorization from the FDA for the setting.

To date we have not in fact authorized a serology assay. That should change 

in the relatively near future though as some of these are - have begun coming 

through our EUA process. So be on the lookout for that. Also I would say that 

we are starting to hear complaints from a number of different sources that 

these rapid serology tests that are listed under Policy B under our frequently 

asked Web site that they’re making claims that they are authorized by the 

FDA and that they can be used for diagnosis. Those seem to be not in line 

with our policy and when we find out about this we will be contacting those 

companies and correcting their misinformation. So hopefully that has clarified

this policy around these - this particular non-EUA authorized category of test. 

And with that I turn back over to Irene and the operator to take questions. 

Thank you.

Irene Aihie: Thanks Timothy. (Jennifer) we’ll now take questions from our participants.

Coordinator: Thank you. We will now begin the question and answer session. Please note 

that you will be allowed to ask one question at a time so if you would like to 

ask a question please press Star 1, unmute your phone and record your name 

clearly. If you need to withdraw your question please press Star 2. Again to 

ask a question please press Star 1 and it will take a few moments for questions 

to come through. Please standby.

Irene Aihie: And while the operator is getting the questions in queue, we did have a few 

questions come through via the chat and as you mentioned we’ll only be 

taking questions by the phone, but while she gets folks into the queue,

Timothy the first question that we had is does the lab need to validate each 

transport media or to CDC EUA test?
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Timothy Stenzel: So labs under our updated guidance are able to make such changes on their 

own to an EUA device. That could include their own EUA that they’ve

attained if they’re laboratory developed test or if they obtain an EUA kit from 

a manufacturing source. They are - we expect that they will do the appropriate 

validation before they implement those changes under a so-called bridging 

study. You can reach out to the FDA if you have any questions about that.

We do not ask for those bridging studies to be submitted to the FDA although 

if you do them and you think it might be useful to other labs and you wish to 

share that data and that information if you send that voluntarily to the FDA we 

will review that data and if we can put that on to our Frequently Asked 

Questions page based on the data that you generated we will in order to help 

all labs and perhaps only one lab really needs to do this.

But if it is something that is already on our Frequently Asked Questions page 

we view those as mix and match. And we thank CMS and CLEA who have 

updated through an announcement that they are allowing lab directors to make 

the decision about whether additional validation is needed in the case where 

the FDA has already listed these options on our Frequently Asked Questions 

page. So hopefully that addresses that question appropriately. Thank you.

Coordinator: Thank you. The first question over the phone comes from (Amanda Barton). 

Your line is now open.

(Amanda Barton): Hi. I was wondering if there is any updates as far as larger scale serology 

testing coming through the United States.

Timothy Stenzel: Hi (Amanda). We are very interested in that and we’re talking to a number of 

developers and we’re very eager to get such a platform into the United States 
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and that of course would come through the EUA authorization process. So 

something like that could happen in the relatively near future so stay tuned. 

Hello?

(Amanda Barton): Sorry, thank you very much. Sorry.

Timothy Stenzel: Okay it - does that address your question?

(Amanda Barton): Yes.

Timothy Stenzel: All right, thank you.

Coordinator: Thank you.

Irene Aihie: Operator we’ll take our next call.

Coordinator: Thank you. The next question comes from (Brandt Mitler). Your line is now 

open.

(Brandt Mitler): Hello. I have a two-part question. Number one under Policy B once a 

manufacturer has notified you with all of the requisite information what are 

you calling your response? I realize it’s not authorization. What are you 

calling the response and how can one track the progress of that notification?

And number two if one or more foreign manufacturers were - are interested 

and they are in participating in a clinical trial at - of the validity and accuracy 

of these foreign tests in a US major medical school laboratory is there a 

contact officer person at the FDA that we can talk to?

Timothy Stenzel: Absolutely. We would welcome such a study in order to show if - which of 

these tests -- maybe all hopefully have high accuracy. And so I’ll address the -
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I think the second part of the question first. You can simply contact us at our 

email address for EUAs and that is cdrh-euatemplates, the word templates 

with an S at the end @fda.hhs.gov. And if you or someone else were to do 

such a study we would welcome it of course. We would if you want to discuss 

how best to maybe design such a study we’d be happy to give you our 

thoughts about that.

I would just say in general that we would expect to see a minimum for good 

testing of these devices a minimum of say 30 positive patients, positive with 

some obviously IgM alone some that are going to have IgM and IgG. The 

number of patients in the US now with only IgG is probably limited and we 

understand that and we wouldn’t necessarily expect to see that. You know, 

that’s a bare minimum. It would be nice if possible to get 30 IgMs and 30 

IgGs and some of them can be overlapping.

The other general advice that we’re giving for the validation of these kinds of 

devices is that it may be very difficult to get panels of immune serum. In 

particular we want to know if there’s cross-reactivity with any non-SARS 

coronaviruses that normally circulate during respiratory season than perhaps 

other times of the year. There are four main types that we - I think we have 

listed in our - in one of our - in our templates and we would of course love to 

see immune serum against those in more than single isolates.

That would be the best test to know if the SARS COVID-2 rapid tests are 

specific for (Com) SARS CV2. But in the absence of that we are allowing 

developers to test a panel of at least 75 non-SARS CV patients who should be 

negative for antibodies against SARS CV2. We would expect to see as much 

variety in those negatives as possible and where possible know the immune 

status for some of the common respiratory viruses. So could you let me know 

if I’ve addressed all of your questions?
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(Brandt Mitler): Yes the - only the first one was - thank you very much on that. The first part 

was what is this process that your - that we call or that you’re calling after 

notification during this pending period where the manufacturer is waiting back 

to hear from you under Policy B?

Timothy Stenzel: Yes, so what we’re doing is we’re taking a look at their marketing materials 

and making sure that they fall appropriately under this policy and that they be 

following this policy and we try to turn that around quickly. And once we 

have made that decision and informed them we will issue them a number. 

That is not an EUA number as some have confused that. That is not EUA 

authorization number, but that is a number so that we can identify that device 

going forward in the future.

(Brandt Mitler): Thank you very much.

Timothy Stenzel: You’re welcome.

Coordinator: The next question comes from (Chen Zang). Your line is now open.

(Chen Zang): Hello. Yes my question - hello. I think first I would like to say thank you to 

FDA reviewers and managers for your dedicated hard work during this time. I 

know a lot of people are working around the clock. Thank you. And my 

question is about Section D serological test. And so if the test use an 

instrument to measure like the flu resin signal or to make a detection should 

the instrument be listed separately as under its own instrument product code?

And my second question is we made minor changes to the package insert after 

notification like extending the shelf life and but no big changes like remove 
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the limitation language, not those big changes. Are we allowed to make 

changes to the package inserts after notification? 

((Crosstalk))

Timothy Stenzel: Yes, yes you can if you’ve notified us under Policy D we would view the 

instrument that performs that testing as part of that - just as part of the policy 

and should be linked unless you want to come in for an EUA and then it 

would be a little bit different. And changes, minor changes to shelf life and 

things like that if there are performance differences for which we usually 

review package inserts prior to putting your name up on our Web site we 

would like to know if there’s any performance changes. But minor changes 

such as shelf life do not need to be - we don’t need to be notified about that. 

Hopefully that helps you out.

(Chen Zang): Thank you.

Timothy Stenzel: You’re welcome.

Coordinator: Thank you. The next question comes from (Hector Moldinaro). Your line is 

now open.

(Hector Moldinaro): Yes thank you so much. Thanks for the invitation and again I want to also 

acknowledge your guys’ hard work, dedication and tireless efforts so thank 

you all for what you’re doing.

Timothy Stenzel: You’re welcome.

(Hector Moldinaro): So I work for SD Biosensor and I just wanted to clarify. So we have four 

different devices. We have one that’s an immunofluorescence assay testing 
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quantitative. It is approved in Europe. It’s been out for quite some time. So 

I’m also in the National Guard. I’m a part of the military for the last 24 years. 

So I sent an email earlier when I was a commander or guardian in New York 

City in 9/11 and we had very limited resources. It would be really nice to get a 

lot of stuff in as quick as we could. So every night I hear Governor Cuomo 

saying that there is a shortage of tests and the national guards are exposed. So 

am I clear in that under the EUA policy D that we could bring our test in for 

military use?

Timothy Stenzel: So...

(Hector Moldinaro): What’s the (unintelligible) needed?

((Crosstalk))

Timothy Stenzel: Go ahead.

(Hector Moldinaro): Yes so my question is what’s needed and what are the steps to import tests

from Korea?

Timothy Stenzel: Okay well first of all thank you for your service. Second let me just follow-up. 

So this is an IgG IgM that would fall under a serology test that would fall 

under Policy D?

(Hector Moldinaro): Yes so it’s yes IgM IgG it’s a dual FIA test.

((Crosstalk))
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(Hector Moldinaro): It’s - so it’s basically the same as an HIV test which we also have that’s 

widely used throughout the globally really. So what’s the...

Timothy Stenzel: Yes, no I mean if you want to follow Pathway D you just, you know, you 

notify us and you label the test appropriately. Since you have - I think you 

mentioned CE mark in your remarks that you have CE mark for this you may 

have enough data to seek an EUA authorization and we’d invite you in. In the 

military setting what kind of setting would it be? 

(Hector Moldinaro): So my concern is for all of the guard units that are mobilized now. So 

when I see them on TV these are young kids. Maybe they’re - it’s not going to 

affect them but they do have parents that are elderly. They have grandparents 

that are elderly. So at least having it for our first line leaders and the use for 

military to test these young...

((Crosstalk))

Timothy Stenzel: Okay. Well I would expect that you would have some sort of temporary 

healthcare facility that you would set up in such an environment and it would 

be covered under our thoughts of near patient testing that I explained first 

thing on the call which is on our FAQ page. We are not - at this point we do 

require EUA authorization for at-home use so and also the requirements are 

that a healthcare professional be involved in the testing with this Pathway D.

So that’s where if this testing is done and that sort of location it does need to 

be under the supervision of a health care professional.

(Hector Moldinaro): Yes, so for military use it would be under whether it’s a physician 

assistant or a unit surgeon or something like that there would be...

((Crosstalk))
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Timothy Stenzel: That sounds good to me.

(Hector Moldinaro): ... medics. Okay, so just follow Policy D and apply the...

Timothy Stenzel: Yes.

(Hector Moldinaro): ...the EUA authorization?

Timothy Stenzel: No, you just notify us and then you’re allowed to import it. If you have any 

issues of importation reach back out to the notification email as I mentioned 

earlier and we will address those important issues as soon as we can.

(Hector Moldinaro): And how long roughly is the turnaround time for that authorization?

Timothy Stenzel: I don’t know what the averages. Obviously we try to do all of these things as 

quickly as possible. We are quite busy and everybody’s important. And we 

have a number of these devices already on our page so we’re gratified that so 

much - so many EUAs have already been authorized and so many labs have 

notified us that they’re doing their own LVT, so many companies have 

notified us that they intend to file EUAs and that they’re on the market, et

cetera.

So we have - we are working with hundreds of different developers right now 

and we have a great team and they’re really dedicated. So if it’s taking a little 

bit longer than you think, just send us another email, you know, to make sure 

that we haven’t forgotten about you which we don’t but don’t hesitate to ping 

us again if you’re not getting an adequate response time.

(Hector Moldinaro): Okay, great. Thank you very much -- appreciate it.
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Timothy Stenzel: You’re welcome.

Coordinator: Thank you. The next question comes from (Sue Warner). Your line is now 

open.

(Sue Warner): Yes hello thank you. My question is related to Part D of the guidance as well. 

And my question is if a serological test is validated for whole blood can they 

be used for capillary blood?

Timothy Stenzel: Yes, what does the manufacturer’s instructions for use say, just whole blood,

not capillary?

(Sue Warner): Whole blood, correct.

Timothy Stenzel: Yes so capillary blood can obviously perform a little bit differently than a 

venipuncture sample for some devices. So if you’re going to change the test in 

any way I would suggest that you do some sort of bridging study between 

venipuncture and capillary so that you can ensure yourself but the two tests 

will perform equivalently. That sort of bridging study is you’re not required to 

submit that to the FDA for review and any sort of EUA authorization but 

again if you do that sort of study to update, you know, a sample type like that 

we would love to see that data voluntarily and in order to continue our 

assessment of the performance of these devices on the market.

(Sue Warner): Okay thank you.

Timothy Stenzel: You’re welcome.
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Coordinator: Thank you. The next question comes from (Elliot Cowan). Your line is now 

open.

(Elliot Cowan): Hi thanks. Another Part D considering that it EUA isn’t necessary for the IgM

IgG test that are used - are the sole basis for clinical decision-making and the 

test is labeled like that, should the manufacture label be used for IVD use or if 

not what other labeling recommendations do you have?

Timothy Stenzel: We are allowing them to be marketed as IVDs in the United States so yes for 

IVD use is appropriate.

(Elliot Cowan): Got it, thank you.

Coordinator: Thank you. The next question comes from Chris Emery. Your line is now 

open.

Dr. Chris Emery: Dr. Chris Emery from Indiana University. Yesterday there were multiple 

media reports about an EUA authorization for body sphere that a rapid point

of care test actually had been authorized. I’d just like some clarity on that 

because in this presentation it was stated that no serological assay has yet been 

authorized.

Timothy Stenzel: That is correct. We have not authorized any serological tests right now and the 

- if someone should be listed under our Pathway D list they should not be 

saying that it is EUA authorized. And we have heard about that complaint and 

they are following-up on that.

Dr. Chris Emery: Okay and just one more question because I’m a clinical pathologist and 

laboratorian. Can you give us perhaps any possible projection on when we 

might be seeing some of these applicants for EUAs actually authorized?
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Timothy Stenzel: Yes, I’m hoping this week.

Dr. Chris Emery: Okay.

Timothy Stenzel: Maybe even today but no promises.

Dr. Chris Emery: Thank you.

Timothy Stenzel: You’re welcome.

Coordinator: Thank you. The next question comes from Dr. (Jonathan Wiener). You line is 

now open.

Timothy Stenzel: Hello?

Coordinator: It looks like the line disconnected. The next question comes from (Eric 

Cabrins). Your line is now open.

(Eric Cabrins): Thank you so much for the sessions and for your leadership during this time. 

My question is can the FDA speak to the reporting expectations of positive 

diagnoses or presumptive positive diagnoses to the CDC and or state health 

agencies for the manufacture of an at home nucleic acid test that’s paired with 

a mobile application connected to the cloud?

Timothy Stenzel: Okay so you’re interested in an at-home test. Do you have such a test already 

produced and ready to be used?

(Eric Cabrins): We’re in the process of development right now and have started the 

conversations with FDA.
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Timothy Stenzel: Great, great. So again what are your specific questions because we certainly 

welcome this kind of development? We think that the appropriately - the 

appropriate testing in the home environment or self-testing is - will be a part a 

strong part of our response to coronavirus. So...

(Eric Cabrins): Okay.

Timothy Stenzel: ...can you just rephrase your question?

(Eric Cabrins): Yes thank you for your support. My question is regarding the reporting 

expectations of presumptive positive diagnoses. As the manufacturer of an athome test it isn’t clear how those laws apply to us.

Timothy Stenzel: Yes, okay so first of all the technology is it molecular?

(Eric Cabrins): Yes.

Timothy Stenzel: Okay.

(Eric Cabrins): Yes it’s a nucleic acid test.

Timothy Stenzel: Nucleic acid test okay yes. Proteins or molecules too and nucleic acid is what 

I should say. You know, so part of this will depend on the performance of the 

assay. Is it - does it perform in comparison to a central already central lab 

already EUA authorized device or you can use one of the point of care already 

EUA authorized devices as a comparative tour. If you want to do that that 

would be ideal but it’s not necessary. You can also follow our regular 

guidance and that’s sufficient for this particular use.
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In the in-home setting I’d also say that we are look at actual user safety. So if 

there’s an instrument user safety is important. If there’s any collection 

devices, user safety is also important whether it be the actual collection 

instrument or what’s in the collection article. Those are all important 

questions.

If the performance is sufficient and if and they can be relied on the only real 

issue is how that result is reported back into the healthcare system. So perhaps 

you have some ideas that you want to share or thoughts or ask questions about 

but it’s really how do you link a result that’s obtained in-home use to an 

individual patient?

Now I have heard I think this is public knowledge that there are some 

telemedicine portals that are being proposed to be able to do this even under 

supervision and guidance of a clinician or a healthcare professional so that the 

testing is done appropriately, that the results are understood and can be 

interpreted by the healthcare professional. And do you have any follow-up 

questions on what I’ve said?

(Eric Cabrins): Yes this is very helpful. I think maybe in the interest of letting other people 

ask questions I’ll follow-up with you and your team in our subsequent 

meetings but thank you very much for this information.

Timothy Stenzel: You’re welcome, you’re welcome.

Coordinator: Thank you. The next question comes from (Michael Roth). Your line is now 

open.

(Michael Roth): Hi. Thank you very much for the time. A very simple question as you may 

have heard a number of us we’re on the Webinar and heard nothing. So is this 
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going to be recorded and made available or can you possibly go over the 

opening remarks which none of us heard?

Timothy Stenzel: Really?

(Michael Roth): Yes really.

Timothy Stenzel: Operator are you on? Did we start recording from the beginning?

Coordinator: Yes sir. We have recorded from the beginning. There will be no audio heard 

over the WebEx however.

Timothy Stenzel: What do you mean by no audio over the WebEx?

Coordinator: During the live call there is no audio provided through joining the WebEx. It 

all needs - it is all provided by dialing in.

Timothy Stenzel: Oh calling in...

Coordinator: The recording will have both the audio and the WebEx together.

(Michael Roth): We’ll honestly we - a number of us did dial-in and heard silence. We were on 

the WebEx and we heard silence and then somebody in the group in the chat 

provided a secondary dial-in number which is what I’m on now. And basically 

I got in at the very end of your remarks and I think a lot of people would very 

much like to hear your opening remarks...

Timothy Stenzel: I will go back...

(Michael Roth): ...because I think they answer a lot of questions.
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Timothy Stenzel: Yes I’m sorry about that. There’s a lot of people using these kind of sessions. 

So I will go through them again. Did you have any other questions while I 

have you on the line otherwise I will...

(Michael Roth): Well I don’t want to waste anybody’s time. I really wanted to hear the 

opening remarks because I...

Timothy Stenzel: Okay.

(Michael Roth): ...from what I heard on the tail end they were very salient.

Timothy Stenzel: Okay well let me just briefly go through their first remark and I won’t go 

through all the updates to the FAQs but do check the FAQs. There have been 

updates since last week. One of those updates had to do with what we mean 

by near patient testing or point of care testing. We will note terms like patient 

care setting outside of the clinical laboratory environment or near patient 

testing or point of care in our EUA authorizations. And this generally refers to 

settings that where appropriately trained individuals are able to perform the 

tests and may include settings such as hospitals, physician offices, urgent care, 

outreach clinics and temporary patient care settings.

These terms generally do not apply to home collection, specimen collection or 

home testing unless otherwise specified. I also talked about the proper 

advertising and marketing of the rapid serology tests. These if they’re under 

Policy D are not to be advertised as EUA authorized because they are not. 

They have not received FDA authorization. They should not be making these 

claims.
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You can say that the FDA has allowed this to be marketed under Policy D. 

That would be very correct. And then let’s see what was the other thing that I 

covered? I think those were the main things. But anyways it will be recorded 

and transcribed so you can check that later on if I missed anything that was of 

importance.

(Michael Roth): That would be great. A quick question about that did our pharmacies with 

proper personnel included in point of care?

Timothy Stenzel: Yes. But it’s maybe a practice of medicine question. That’s not something 

that’s under the FDA jurisdiction.

(Michael Roth): Okay.

Timothy Stenzel: So look at your state laws.

(Michael Roth): Correct. Thank you very much and keep up the good work.

Timothy Stenzel: Thank you.

Coordinator: Thank you. The next question comes from (Becky Habert). Your line is now 

open.

(Becky Habert): Hi. So I work for a company in Canada. And we don’t currently provide any 

FDA approved or cleared products. So we’re working on a quality 

management system to prepare for eventual approval or clearance. But what 

I’m hoping you can help me out with is clarification on the description of the 

waived elements for the COVID-19 EUA. I’ve looked at a number of 

authorization letters and it seems that some elements of A20 are being waived. 
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And so I guess what specific sections of 21-CFR 820 does FDA expect to see 

from a company providing tests under the EUA?

Timothy Stenzel: Okay and so this would be something that would come in for this would be a 

lab developed test or this would be a manufactured test for distribution?

(Becky Habert): Kind of a mix I suppose. I mean we would be developing the test and then 

likely finding a lab partner in the US to actually...

Timothy Stenzel: Okay.

(Becky Habert): ...provide the test.

Timothy Stenzel: Okay. All right well that’s you would potentially be described as a 

manufacturer.

(Becky Habert): Okay.

Timothy Stenzel: And may be held to if you’re - it depends on how you develop and produce 

the test. If you’re manufacturing the reagents and shipping them to a lab then 

you would be judged as a manufacturer. I am not actually up to speed on what 

parts of A20 are required under EUA. And I would suggest that you ask for a 

very good question to our cdrh-eua-templates email address.

(Becky Habert): Okay.

Timothy Stenzel: And I will actually learn something in the process as well about what we 

waive under EUAs.

(Becky Habert): Okay thanks very much.
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 22

Timothy Stenzel: You’re welcome.

Coordinator: Thank you. The next question comes from (Sarah Kalil). Your line - her line 

just disconnected. The next question comes from (Les Wilson). Thank you.

(Les Wilson): Thank you very much and I want - I send my appreciation for all your hard 

work. My question has to do with the serology test and does the FDA have a 

source or can you recommend a source of positive material that we could 

acquire for validation? And is there any restrictions in importing this positive 

material for QC validation?

Timothy Stenzel: So obviously negatives in the United States should still be easily obtained 

especially if they are banked from prior to the epidemic. We are aware that 

our - there are foreign suppliers of panels of serologies that would be 

appropriate for this however we don’t necessarily know the quality of that. So 

we would certainly look to you to ensure that the quality of these panels is 

good and accurate for what you intend for it to do.

If you were to have any trouble importing those do let us know at our cdrheua-templates address and we will work with you on any potential import

issues so that you can do this validation. We are reaching out to a number of 

entities in the United States in order to facilitate the collection and 

development of panels of immune serum for SARS COV-2. This is actually 

an interagency effort now involving CDC, BARDA, ASPR and the FDA. And 

we are in the beginning stages of this work and so I can’t report any success at 

the moment but we will be updating our Frequently Asked Questions page 

with regard to resources that could be used.
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 23

In the interim I know that there is at least one lab in New York that has begun 

offering a test probably because New York is one of the states that can 

authorize their own SARS CV tests. So there may be others in New York that 

are under this or when we are able to authorize the serology test whether that’s 

an LDT or a manufactured test that could - anybody who utilizes that test or 

that testing service could potentially identify such immune serum.

(Les Wilson): And so you’re saying that I need to keep in touch with the - your Frequently 

Asked Questions page and when you have anything like that posted it would 

be there. Is that correct?

Timothy Stenzel: Yes exactly. We’re looking at how we can develop panels that could 

potentially share with developers and/or labs that could do that testing as a 

third party. So we are in the initial planning stages of how to roll that out and 

initial discussions but this is a large federal effort at this time.

(Les Wilson): Thank you very much and once again great job.

Timothy Stenzel: Thank you.

Coordinator: Thank you. The next question comes from (Mark Coudier). Your line is now 

open.

(Mark Coudier): Hi. My question is actually in regards to the part D Pathway. I think a lot of us 

in the laboratory community are curious how thoroughly this validation data 

submitted by manufacturers is being evaluated by the FDA. And what 

measures are in place to ensure that were not going to see any manufacturing 

quality control issues that cause significant damage in Spain and Italy with 

regard to inconsistent products and citizens offices performing it without any 

experience in monitoring such quality?
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 24

Timothy Stenzel: Yes, no that’s a very excellent question. We came up with this pathway to 

expedite tests that were not for sole diagnosis to get onto the market. We have 

a parallel path where there is a full EUA authorization review that’s open to 

these developers. And we would encourage them to come through that 

pathway. But for the time being they cannot claim FDA authorization. We are 

solely allowing them to be marketed. So I would urge those that buy these 

tests is to do some sort of verification of the performance. That’s not required 

but I think it’s only wise.

We are aware of the Spanish situation and particularly the business insider 

article. And it’s why we are currently standing up this federal effort. We hope 

and we have already begun inviting these serology test providers to come in 

voluntarily to undergo a third party validation program. We are just in the 

beginning stages of that. Once that program is up and running and we are able 

to verify the performance that are stated in their package inserts we will make 

that information publicly known.

(Mark Coudier): I totally understand and agree with that. I think the problem is, is that is 

assuming that these are being marketed, purchased and performed by 

laboratory personnel and unfortunately we’re seeing in our community that’s 

not the case, that they’re being aggressively marketed to small physicians’ 

offices. There is no technical laboratory expertise and the physicians are 

essentially unboxing, running and taking it as gospel and I think that’s really 

scary.

Timothy Stenzel: Thank you for sharing your concerns. They’re not necessarily unwarranted 

and it’s why we’re standing up this effort right now. If you hear of any false 

claims or if you hear of any absolute performance issues we will - we would 
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 25

like to hear about that and you can send it to us at our cdrh-eua-templates 

email address. And we will absolutely investigate complaints of that sort.

(Mark Coudier): All right thank you.

Timothy Stenzel: You’re welcome.

Coordinator: Thank you. The next question comes from (Sarah Kalil). Your line is now 

open.

(Sarah Kalil): Thank you very much. Can you hear me? Hello, can you hear me?

Coordinator: Yes, we can hear you.

(Sarah Kalil): Excellent thank you. My last time I got cut off. I have a two-part question on 

sample collection. And the first part is does the FDA have any data on the 

acceptability of a saliva sample for detecting SARS CV2? Hello?

Coordinator: Excuse me I have joined Tim back to the call. Thank you.

Timothy Stenzel: Hello everyone, sorry about that technical issue. Somehow I was knocked off 

the call and then I couldn’t call back in because there’s too many people on 

this call which is a good problem to have. Anyways I’ll take additional 

questions in the time remaining.

(Sarah Kalil): Great Tim. This is (Sarah Kalil). And first thanks to you and your colleagues 

at the FDA. The response has been amazing. I represent industry. And so my 

first question and it’s actually a two-part question first is does the FDA have 

any data on the acceptability of saliva as a sample type for detecting SARS 

CV2?
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 26

Timothy Stenzel: We’ve been - I presume you mean by nucleic acid methods?

(Sarah Kalil): Yes thank you.

Timothy Stenzel: Okay. So we have developers both for serology. You can, you know, do 

things like IgA in saliva but we have quite a bit of interest in other sample 

types for nucleic acid-based testing. We in the United healthcare group study 

which I still don’t know if it’s been published yet we looked at what was it 

tongue swab which may simulate somewhat saliva or it may not because 

there’s not a whole lot of volume there and more volume of saliva make a 

difference. But anyways in that comparison there was not good correlation 

between the cycle thresholds of the tongue sampling and a swab and the

nasopharyngeal comparator. There was actually no correlation to CT. So we 

became a little bit concerned at least with the tongue swab.

I do not know if a higher volume of saliva would work better. We do have 

parties who are interested in going forward with saliva tests. Because it is a 

new anatomical site we would want to do for any LDTs or any manufactured

tests we would want to have an EUA amendment to review that data before 

we authorize it. And then obviously once we make saliva available as a 

reliable sample type from an anatomical site then we can make that widely 

known. Hopefully that addresses your question.

(Sarah Kalil): Sure it does. And I think that if the agency could provide guidance to industry 

that desires to collaborate on that it would be wonderful because that’s 

certainly opens up a number of possibilities with sample collection. The 

second part is on the subject of sample collection and in the case of a 

nasopharyngeal sample if the agency were to agree to a home setting sample 

collection is there a feeling that that would have to be observed via 
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 27

telemedicine? You know, what is the sentiment on the nasopharyngeal sample 

collection in a remote setting?

Timothy Stenzel: Yes that’s a great question. Have you ever had a nasopharyngeal sample 

performed on you?

(Sarah Kalil): I haven’t but some of my colleagues have described it and I do understand that 

it’s highly uncomfortable, hard to inflict upon yourself and so that really 

raises the question of would it need to be observed from a telemedicine 

perspective?

Timothy Stenzel: It’s not the - I mean of course if someone comes in with data and says that 

patients can do this and they have no on results but I don’t I would advise 

against it. There - I think there is - there’s danger of self-harm or from 

someone else doing it improperly. Also it tends to make patients sneeze and

cough which could...

(Sarah Kalil): Right.

Timothy Stenzel: ...make, you know, infectivity increase. So we have already seen data that 

says the interior nasal swab particularly the only swab that has been validated 

in that in a (unintelligible) site right now is the round foam swab. We know of 

others who are validating other swabs that could be used for interior nasal but 

I think in the home care setting if someone wants to pursue that, an interior 

nasal swab in both nostrils need to be sampled. And then, you know, if it’s a 

simple safe device, that’s something that in the home setting that we want to 

take a look at.

But the United Health study already demonstrated that interior nasal swab 

could be self-collected. So that’s not approved. What we are looking for is on 
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 28

home collection at this point for something like that because that is the media 

that’s used, is it safe for the home environment? And is a sample that is 

returned from a home setting through a shipping is it intact so that you have 

no false negatives from that transport of that.

And if it uses - happens to use media that’s already been FDA cleared for such 

transport then maybe that isn’t needed but it’s usually typically a simple in lab 

bench study to demonstrate that the temperatures that the sample may be 

exposed to near the LOD of the assay with a sufficient replicates that you can 

demonstrate adequate performance from a shipment from the home setting.

(Sarah Kalil): Terrific, that’s incredibly helpful. Thank you Timothy.

Timothy Stenzel: You’re welcome.

(Sarah Kalil): The next question comes from (Erika Almardi). Your line is now open.

(Erika Almardi): Hi. Thank you and thank you Tim for holding these. Getting back to serology 

there, two related questions. One is you spoke of an EUA for home use and 

that’s on the forefront is there an FDA template for EUAs from the serology 

side or do we just use our best knowledge of how to do that? And then related 

to that if you wanted to go the EUA route for a professional use that would 

take you beyond the notification. Is there a template for that or would they be 

the same or how would one go from a notified serology to an EUA?

Timothy Stenzel: Yes that’s a great question. So home use serologies introduce some additional 

variables that are important to demonstrate safety her.

(Erika Almardi): No absolutely. I was just asking. I don’t want to take up everyone else’s time 

so...
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 29

Timothy Stenzel: But I do want to - I think it’s important to say that how you collect the sample 

which is usually a blood sample, I mean this isn’t necessarily performed 

routinely by anybody other than maybe a diabetic.

(Erika Almardi): Right.

Timothy Stenzel: And then the use of such a device that’s intended for healthcare setting and the 

reading of it is not usually intended for the home use and we are open to it. 

There are clinician observed methodologies in the home they could be called 

upon. And I would urge you to consider those and to reach out through our 

email address to ask about how you might design and market such a device 

and do the study to show that consumers, lay users with simple instructions 

and perhaps in the right situations, you know, under observation can perform 

these testings - testing at home.

(Erika Almardi): Okay, but as of today there is no prescribed templates for that?

Timothy Stenzel: No, we haven’t been approached by multiple developers in this area. And the 

other thing is how does a patient interpret the result too? So that’s why it’s 

really important for a clinician, healthcare provider to be involved in that part 

of the assay as well.

(Erika Almardi): Okay great. Thanks very much.

Coordinator: And our last question comes from (Marade Oxu). Your line is now open.

(Marade Oxu): Hello. Hi.

Timothy Stenzel: (Unintelligible).
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 30

((Crosstalk))

(Marade Oxu): First of all I want to thank you so much from the bottom of my heart for 

everything you guys have been doing since this unfortunate have started 

happening. I have a couple of questions. I’m going to try my best to 

summarize it. 

First one is that you mentioned about the Policy C on Frequently Asked 

Questions on your Web site. And I’m actually checking out your Web site 

right now and I have been checking it for the past couple of weeks. And how 

often does that section get upgraded updated because there’s a company -- I’m 

not going to give name at all of course. There’s a company they received DUI 

authorization on March 26 last week. And that company’s name still on that 

Frequently Asked Questions section. It’s not been updated at all.

Timothy Stenzel: So okay so they previously notified us and it’s they’re - are they notified of 

the EUA page as well?

(Marade Oxu): Yes, yes on the UA page the date shows March 26 they received it but on the 

Frequently Asked Questions the company’s name still there saying that FDA I 

cannot read it right now. The FDA has not reviewed the valuation of this test 

or these manufacturers or issued EUA for these manufacturers and there’s a 

name there. But same manufacturer that received EUA on March 26 last 

week.

Timothy Stenzel: Okay, thank you for pointing out that error. I’ll alert our Web folks and they’ll 

make that correction. Thank you.
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 31

(Marade Oxu): Sure, sure okay. Real quick, second one is, I’m curious about the product 

called Q as in Question, Jay as in James, R as in Richard. Does that mean that 

this product has been EUA approved?

Timothy Stenzel: Those product codes have to do with the type of a device and the analytes. 

And it specifies our regulation that we follow. So it simply is a way for us to 

classify devices so that they are reviewed by the correct experts within our 

office and they are all handled equivalently as far as FDA regulations go.

(Marade Oxu): I see okay I have noticed but I was just wondering what it means. Last one is 

that it’s a general question I’m trying to understand this timeframe. Once the

manufacturer - under again the question is under Policy C. Once the 

commercial testing kits manufacturer does all their verification and validation 

through their own clinical evaluations, clinical trials and officially submits to 

you guys their EUA application from that timeframe how long does the FDA 

have to approve this manufacturing testing kit? Is that 15 days business days 

or 15 calendar days?

Timothy Stenzel: So the 15 business days are the time between the manufacturer notifying the 

FDA and when they need to - the deadline for what they need to submit the 

application to the FDA for EUA review. Because we have listed that 

manufacturer on our Web site already there is - and you’ve been able to be on 

the market for three weeks before we’ve even seen the package...

(Marade Oxu): Yes.

Timothy Stenzel: ...there’s a benefit to that. We are typically not in a rush to review that 

package. We will take a high level review to make sure that there’s nothing 

that looks like it may be incorrect. Once we receive it you should receive a 

notification that we’ve received it and that we have begun our review. And if 
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 32

you have not heard from us you can stay on the market but we do to the quick 

high level review to make sure that there are no showstoppers.

And then we try to do it as quickly as possible. And we are getting some of 

those out but they are going a little bit longer then our normal EUA pathway 

where a company has expressed or we’ve expressed the need to do the 

authorization upfront. But now that companies can notify us we feel the 

pressure of our review other than a high-level review when we receive it is off 

so that we can appropriately use the resources in the best possible way.

(Marade Oxu): Oh I see. So there’s no would you say timeframe for the notification you’re 

saying pretty much?

Timothy Stenzel: So yes once we receive the EUA package we do not have a clock. Our normal 

- just so you know our normal 510K clock and that’s in this situation with 

novel coronas the first...

(Marade Oxu): Yes.

Timothy Stenzel: ...submission would actually be a de novo submission and I believe that may 

be 180 days of FDA time. But for our following that de novo 510Ks have a 90 

day clock.

Of course for our non-coronavirus applications right now there may be some 

developers out there that are wondering what we’re doing with those. We 

obviously are - it’s all hands on deck addressing...

(Marade Oxu): Yes.
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 33

Timothy Stenzel: ...coronavirus. And unless that there is some urgent unmet need equivalent to 

this emergency there may be some delays in the reviews of those noncoronavirus applications. We just - it’s an opportune time to say giving people 

a heads up and we hope that they are understanding of that situation.

(Marade Oxu): I see. I understand, okay. It was just again I’m not here to give any names but 

there was just a specific question about this specific company. I mean they’re 

pretty much on their Web site already doing what you guys are required them 

to do mentioning all these 100% specificity on 100% quality everything else.

And they have been selling all around the world and they have all the CE 

mark and they already submitted all their clinical successful evaluation,

verification, validation with your help with your guidance already on March 

20th and still no response from you guys. And I was wondering when would 

that be...

Timothy Stenzel: If you - so has this company notified us through Policy C and have they listed 

on the Web site? Hello? Am I knocked off again? No?

Coordinator: No. No that caller has been disconnected sorry.

Timothy Stenzel: Okay. Well anyway if you have questions about any sort and you haven’t been 

able to ask your question please submit them to 

cdrh.eua.template@fda.hhs.gov. Thank you so much, appreciate everybody 

participating on this and again we’ll meet again in a week. Thank you.

Irene Aihie: Thank you everyone. This is Irene Aihie and we do appreciate your 

participation and thoughtful questions. Today’s presentation and transcript 

will be made available on the CDRH Learn 

webpage@www.fda.gov/training/cdrhlearn by Monday, April 6. If you have 
FDA CDRH

Moderator: Irene AIhie

04-01-20/12:15 pm ET

Page 34

any additional questions about today’s presentation please use the email cdrheua-templates@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/cdrh Webinar immediately following the conclusion of today’s 

live discussion. Again thank you for participating and this concludes today’s 

discussion.

Coordinator: Thank you for your participation. You may disconnect at this time.

END