FDA Virtual Townhall

Moderator: Irene Aihie

4-08-20/12:15 pm ET

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FDA Series – Virtual Townhall Series 

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

Moderator: Irene Aihie

April 8, 2020

12:15 pm ET

Coordinator: Welcome and thank you for standing by. I would like to inform all 

participants that your lines have been placed on the listen-only mode until the 

question-and-answer session of today’s call. Today’s call is being recorded. If 

you have any objections you may disconnect at this time. I would now like to 

turn the call over to Irene Aihie. Thank you, you may begin.

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

Education. Welcome to the FDA’s third in a series of virtual town hall 

meetings to help answer technical questions about the development and 

validation of tech for SARS CV-2 during the public health emergency. Today 

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

Radiological Health here in CDRH’s Office of Product Evaluation and 

Quality will present an overview. Following brief remarks we will open lines 

for your questions related to information provided during the presentation. 

Now I give you Timothy.

Dr. Timothy Stenzel: Thank you Irene. Also joining me today is our Offices Chief Medical 

Director. That’s Dr. Sara Brenner. She will be making some brief remarks and 
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addressing certain questions when they come up. So first of all here at the 

FDA we continue to work extremely hard to do our part to get the country 

back to normal as soon as possible. We are reviewing EUA applications as 

quickly as we can and as you see we continue to authorize them on a daily 

basis.

I wanted to address briefly serology tests. They are growing in importance for 

our response to this emergency in order to aid the determination of patient 

immunity and prior exposure. And as a result accurate testing is very 

important. We do continue to welcome all EUA submissions for serology tests

both point-of-care and high volume central lab test development. We think 

both of these are going to be necessary to address the upcoming need in very 

high volumes.

Serology tests have been able to come to the market through different 

pathways. On our March 16 guidance either Pathway C or Pathway D. Many 

have come through the Pathway D where they notify the FDA that they have 

completed validation and then once there is a few exchanges to understand 

that everything is being addressed according to the guidance then those 

developers are - receive a confirmation message and are able to market in the 

US.

We’ve seen a huge number come into the US this way. There has been some 

concern about the accuracy of some of these tests. And so the FDA in 

collaboration with other agencies is standing up a volunteer - a voluntary 

interagency program to help address and verify error accuracy. Developers 

involuntarily participate in this program. They can send their point of care test 

kits and any instrumentation that might be needed to a central location. And 

we are putting together a panel of positive sera and plasma and negative 
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serum plasma in order to take a look at performance of these tests through an 

independent assessment.

If you are a developer and are interested in this program please send an email 

to our general EUA address. That is cdrh-eua-templates with an S

@fda.hhs.gov.

I am going to cover a few of the frequently asked questions in the past week. 

First I’m going to turn it over to Sara to cover a specific topic and then we’ll 

open it up for questions and answers in an attempt to address your current 

needs under this emergency now and stimulate further development and 

further validation of tests and to address this emergency. So let me just pull up 

that.

All right, so there are general questions that we recently received having to do 

with what developers are required to do with regard to validating alternates 

supplies and reagents such as alternate viral transport medias, swabs or 

extraction reagents and instruments and PCR instruments. We do address this 

on our Frequently Asked page but we continue to get questions so I wanted to 

address this. So if you are a holder of an EUA authorization or have submitted 

an EUA and you’re a laboratory you can simply do a bridging study with the 

alternate reagent or supply validate it to your standards into clear standards 

and then you can begin using that. You do not need to submit an amendment 

or an application to the FDA.

If you are using someone else’s EUA authorized device you could do the 

same thing without submitting if you’re a laboratory submit - and submit that 

you don’t have to if you’re a laboratory you don’t need to submit anything to 

the FDA. However in both situations we would love to see the validation 

instrument validation data that you generated in order that it might be helpful 
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to others and with your position would like to add that alternate supplier 

reagent on to our Frequently Asked questions page. So it’s not required to 

submit your data but we would love to see it. If you are a test manufacture and 

you have an alteration to your product yes that does require validation and it 

does require a submission to the FDA usually in the form of a supplement and 

we also work closely with you to address those additions as quickly as 

possible to make more options available.

Next set of questions that are recurring have to do with whether or not home 

collection is allowed and we have said that collection and/or home testing 

require a UA authorization. So if you are interested in this pathway please 

reach out to us at our general EUA address and we’ll work with you to design 

the appropriate studies to ensure that home collection is safe and is accurate 

and that the shipping return to the laboratory is also considered and is 

validated so that we know that when the samples are returned to the laboratory 

accurate results are obtained and false negatives are avoided.

So we do welcome these. We do encourage these however we have stated that 

any EUA authorization is required. We are working with a number of 

developers now and hope to have some positive news in the near future with 

these amendments or these authorizations.

We generally get a number of questions about when you hear back after you 

have submitted your EUA. If you are allowed be on the market with your test 

and do not require an EUA authorization before you can test in the way that 

you want we are triaging those that need our immediate attention. You can 

always reach out to us through the general EUA address or to - if you’re going 

to sign the reviewer to reach out to your reviewer to get an update about 

where you stand.
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We continue to get questions about what states are authorized to review tests 

from that state. You can check our Frequently Asked Questions page for an 

update but currently as far as I know there are six states Connecticut, 

Maryland, Mississippi, Nevada New York and Washington State and then 

there is a question about whether validation should be sent to the state or to 

the FDA. Of course even if your state is willing to authorize tests within your 

state you are always welcome to submit an EUA application to the FDA. And 

then Sara that kind of sums up what I was going to say in prepared remarks. 

Do you want to anything at this time or should we move into Q&A?

Dr. Sara Brenner: Yes, thanks Tim. This is Sara. I was just going to make a few comments on,

brief comments on folks that have reached out regarding 3-D printing and 

additive manufacturing approaches to help address supply chain issues. I 

wanted to quickly point out that FDA has recognized that many stakeholders 

are interested in designing and producing 3-D printer devices and other types 

of and devices that are made through other nontraditional manufacturing 

methods as well.

So what we have done to try to accept different input from the community is 

form a partnership under an MOU with the Department of Veterans Affairs 

innovation ecosystem and the NIH 3-D print exchange to share data and 

coordinate on open source medical products for the COVID-19 response. So 

these agencies were working with closely as well with American made 

supervise resources that will help connect healthcare providers and 3-D 

printing organizations.

So we already have an FDA Q&A that’s available on our Web site for 3-D 

printed medical devices including PPE, decontamination and reuse of 

respirators information, optimizing respirator decontamination and so on and 

so forth. So I would point you to our Web site for additional information on 
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engaging us and our sister agencies on those efforts. Also on a related note 

we’ve been made aware that there is a growing number of institutions from 

academic sector including universities and academic medical centers who are 

interested in contributing personnel expertise, resources and other things at 

their disposal across the country to try to address both local and national 

shortages. So we’ve engaged in dialogue at this point with the AAMCA AAU 

and APLU with regards to how we can all work together collectively across 

the university system as well to help address emerging challenges. Thank you.

Dr. Timothy Stenzel: Thank you Sara. Irene and the operator we’re ready to take questions.

Coordinator: Thank you. As a reminder please limit yourself to one question. Our first 

question comes from (Daniel Simpson). Your line is open.

(Daniel Simpson):Yes hi. Thank you for taking my questions. My question is regarding a 

manufacturer that chooses to do Policy C for EUA of a serology kit. And if 

they have initial validation data that may not complete do you recommend 

doing pre-EUA conversations with that data to understand what additional 

data FDA is requiring?

Dr. Timothy Stenzel: Well if they think they have a complete application they can put in a 

submission using the - I guess we don’t have a template but if you send - if 

they send in an email to our general EUA templates we do have a fact sheet 

that we can provide to them. But if you do think you have a complete 

submission you can make a submission to our - to the submission email and 

we will all take a look at it and if there’s anything missing we can look at - we 

can reach out back out to the developer. On the other hand you’ll also are able 

to do that through the pre-EUA. So whatever pathway you think is most 

efficient for you we’ll work with you on that.
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(Daniel Simpson):Okay thank you very much.

Coordinator: Thank you. Our next question comes from (Heather). Your line is open.

(Heather): Hi there. This is (Heather) from Clinical Reference Laboratory and you may 

have already answered this so my apologies. But I was curious if we are 

looking at alternate sample types I’m guessing that a bridging study will not 

suffice and we will just need to work closely with you to design an 

appropriate study?

Dr. Timothy Stenzel: Yes that’s a great question. So for any sample type that we’ve already

authorized so whether it be NP swab, mid-turbinate, mid-turbinate selfcollected and then healthcare increment nasal swab or a self-collected nasal 

swab in the healthcare environment nasopharyngeal swab or sputum I believe 

that’s a complete list of what we’ve authorized so far.

We have seen some data with regard to a tongue swab and there are interested 

parties in saliva. Some of these alternate samples may not perform as well as 

others so at this time yes we would like to engage on - with the developer on 

an alternate sample type if it’s not one of the ones that we’ve already

authorized. If we’ve already authorized that sample type and you simply want 

to say switch swabs that’s something that you can perform your own bridging 

study if you’re it LDT developer or if you’re altering an EUA authorized test 

and you don’t need to submit that to the FDA. Did that address your question?

(Heather): Yes perfectly. Thank you very much.

Dr. Timothy Stenzel: Okay, and of course if it’s a home collection or a home testing if that’s the 

kind of development work you do yes we also want to authorize those for the 

EUA platform in process.
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(Heather): All right, thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Autumn). Your line is open.

(Autumn): Hi there, thank you. I had a question regarding research components available 

for the development of test. I understand that the March 2020 FDA guidance 

indicates that CLIA laboratories they need to utilize RUO components for 

development of their assays. But similarly does apply to manufacturers and 

specifically instruments? So with the wide availability and cost benefits of 

RUO instrumentation is it possible for kit manufacturers to develop kits for 

use with RUO instruments?

Dr. Timothy Stenzel: Well that’s a great question. Yes laboratories are able to utilize RUO 

components in their lab developed tests as RR manufacturers. Now typically -

oh the excuse me, I’m going to put you on mute and cough. I just had a little 

allergy there I think. Typically outside of an emergency situation we would 

require more work for and an RUO instrument however under the emergency 

authorization Program we will work with developers, manufacturers to 

validate those instruments as well for use with their assays. Does that address 

your question?

(Autumn): So to follow-up would manufacturers be able to develop a test and make 

available that test while issuing an EUA within 15 days or would the FDA 

preferred to engage with those manufacturers before EUA issuance?
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Dr. Timothy Stenzel: They - that’s a great question. Yes, they can follow Pathway C, complete 

their validation and then within 15 business days submit that application. And 

as long as everything looks good we’re good.

(Autumn): That answers my question. Thank you very much.

Dr. Timothy Stenzel: I would add though that there may be challenges once the EUA might 

come to an end. I don’t expect that the emergency declaration will end 

anytime soon. However there is a provision in the EUA statues and regs that 

allows for specific technologies once they come through for a full 

authorization, normal authorization whether that’s usually their de novo first 

and a 510K that there is an option for that particular type of device to be 

removed from the emergency declaration and require full submission. So as 

developers are developing this they should keep that in mind with regard to 

research use instrumentation but there may be a limit beyond an emergency in 

which they could use that other than labs that validate RUOs. They are

potential pathways, it’s just that it’s good to talk to the FDA about those 

pathways ahead of time and be prepared for them. Okay, next question.

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

(James): Hello. 

Dr. Timothy Stenzel: Hello.

(James): Hi. My question is whether serology tests on the testing for the - of the FDA 

guidance can be used in labs with moderate complexity all we were 

(certificate)? I understand that FDA’s statement in the FAQ Web site that 

these tests have not been reviewed by FDA and therefore theoretically they 

are high complexity by default however most of the serology tests are 
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designed to be used in public care that are not high complexity. And it was 

probably not the intention of the guidance to limit the use of serology tests in 

high complexity labs because the guidance does state that serology tests are 

less complex than molecular tests. So that’s my question.

Dr. Timothy Stenzel: Yes, that’s a great question and it’s a challenging question and a 

challenging answer. So under the EUA authorizations we are not making 

CLIA class CLIA classifications as far as high, moderate or waived. And also 

if we do not authorize through the EUA process a test we cannot deem 

something to be CLIA waived which is an alternate pathway under the EUA 

provision. So all tests are typically thought to be or assumed to be high 

complexity tests unless through the EUA authorization process we deem them 

as moderately complex or waived.

This deeming is only something that’s allowed under regs and statutes for 

tests that are authorized by the FDA. And so certainly it was not our intention 

to limit the use of these serology rapid serology tests that are otherwise 

designed to be used in a point-of-care setting. However because of the limits 

that we have in law it is the opinion of CMS that these can be performed in 

high complexity labs.

If a developer wishes to come through a full EUA authorization process with 

their point-of-care test that is always a pathway open and at that point if the 

test is appropriate for a patient or a point-of-care setting we can deem that test 

to be that category and make that clear in the labeling and that then allows the 

device to be used in a near patient point-of-care setting.

We are looking at potential alternate pathways to achieve the same end. I 

mentioned that we have an interagency effort to verify performance of these 

tests. We may have a pathway open through that that we’re looking at. And 
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we encourage all serology point-of-care developers to participate. It’s a 

voluntary program but that would be most helpful I think to everyone. 

Hopefully I answered your question...

(James): Yes.

((Crosstalk))

Dr. Timothy Stenzel: ...but maybe not in the way that you wanted.

(James): It’s okay thank you. Just one quick follow question is when - do you know 

when the template for EUA serology test can be available?

Dr. Timothy Stenzel: So you can send us an email request at our EUA CDRH EUA email and 

we can provide you with a document that lays out what we think is - are the 

studies that are recommended and the manner in which to do them.. We are 

working on a template and as soon as we can we will post that.

(James): Thank you.

Coordinator: Thank you. And as a reminder please limit yourself to one question. Our next 

question comes from (Jeff). Your line is open.

(Jeff): Hi. Yes, similar to the academics with resources that are looking to get 

plugged in I represent a group of roughly 150 lab technicians, lab IT people 

with both hospital lab and independent lab expertise. We’re looking to get 

plugged in on a meaningful and voluntary basis. You know, we’re now 

looking to sell you anything but we’re just trying to get plugged in. You 

know, we can assist with test selection, test validations electronic reporting.
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What’s the best way to do that? I know you have the tool for academics to get 

involved. Is there a portal for those of us in industry that want to get involved?

Dr. Timothy Stenzel: Well we certainly welcome your - the opportunity to work with you and 

your great attitude to try to help on this. Sara do you want to address how to 

connect up with (Jeff)?

Dr. Sara Brenner: Yes, that’s great. And thank you (Jeff) for volunteering this information. It 

might be most expedient if you would shoot me an email and we can pick up 

the conversation from there. Sara, S-A-R-A.brenner, B as in Blue, R-E-N-NE-R@fda.hhs.gov.

(Jeff): Thank you.

((Crosstalk))

Coordinator: Thank you. Our next question comes from (Alice). Your line is open.

(Alice): Hi. Yes thank you. My question deals with the applicability of the tests that 

are currently available whether they be nasopharyngeal or serology testing 

about their applicability and validity on deceased patients since none of those 

kits have cateveric indications for use at this point?

Dr. Timothy Stenzel: That is correct. That is a question I’m going to take back and get prepared 

for. And (Alice) if you were to shoot us an email to our cdrh-eua-templates 

address we will answer you directly. and on the next call after we’ve been 

able to provide some advice and guidance we will respond more globally with 

an answer to that.
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So it’s a great question. I know we’ve authorized an Ebola test for such a 

situation but to my knowledge we have not specifically authorized that. If 

you’re a lab that is using an EUA authorized device, you’re and LDT lab you 

have the ability to validate that through some sort of bridging study or 

whatever validation that you think is worthy of that and no FDA submission is 

required for that particular application.

(Alice): Okay, thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Scott). Your line is open.

(Scott): Thank you. My question’s already been answered.

Coordinator: Thank you. Our next question comes from (Jackie). Your line is open.

(Jackie): Hello? Is this...

Dr. Timothy Stenzel: Hi (Jackie).

(Jackie): Oh hi. Thank you. I work for ET healthcare and our product is a fast highvolume test that actually gives us (unintelligible) readout. We got the 

notification clearance under Pathway D but we would like to submit an EUA 

is a quantitative test. And if the EUA proficient under Policy D does not allow 

the serology test is a quantitative test do we have to just submit a five 10K to 

be a quantitative test on a COVID assay?

Dr. Timothy Stenzel: You’re measuring IgG IgM quantitatively?
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(Jackie): Yes.

Dr. Timothy Stenzel: Okay. And...

(Jackie): I - excuse me, sorry.

Dr. Timothy Stenzel: Oh that’s okay. I’m - I think that is something that we can authorize if you 

want to submit something. That is - whether that’s covered under that 

particular Pathway D I would want to double check for sure. So if you were to 

send an email to our cdrh-eua-templates address and ask that specific question 

I’d like to verify.

(Jackie): Okay.

Dr. Timothy Stenzel: And then once again once we’ve been able to address your specific 

question we can make that more broadly, that information more broadly 

available through one of our town hall meetings.

(Jackie): Okay, I asked that question and the answer was that FDA is not reviewing any 

quantitative tests at the moment.

Dr. Timothy Stenzel: Okay. Well ask them to contact - go back to that email address and asked 

them to bring me involved okay Timothy Stenzel. Ask them to involve me 

okay? 

(Jackie): Oh, thank you so much Dr. Timothy Stenzel. Thank you.

Dr. Timothy Stenzel: You’re welcome.
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Coordinator: Thank you. As a reminder if you’d like to ask a question please press Star. If 

your question’s already been asked and you’d like to remove yourself press

Star 2. Our next question comes from (David). Your line is open.

David Grenache: Hi. Thank you. This is David Grenache out in TriCore Reference Labs at 

Albuquerque. FDA requests that antibody class specificity studies for 

serological testing performed. Are laboratories that are validating 

commercially available tests expected to do that or is that an expectation of 

the manufacturer? And I ask because some manufacturers have indicated they 

have not done that.

Dr. Timothy Stenzel: Yes. That is part of our guidance to manufacturers. And I am not 

necessarily up to speed on what our guidance is to say an LDT. And I would 

want to give you a very direct and transparent and clear answer to that David. 

Could you send an email to our EUA address and ask for me to be involved in 

answering that question and we’ll get back to you really, really quickly.

David Grenache: Absolutely, thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Nikki). Your line is open.

(Nikki): Good afternoon. We’re representing some companies from a foreign 

manufacturer. And - or so different kits. Each of them have notified per Policy 

C, but they are not - obviously they don’t have the EUA issued yet but there is 

- they have notified that they want to distribute and they’re not showing up on 

the section of the Web page that shows the companies that have intended to 

distribute. So I’m wondering I just want to be sure that I’m understanding 

correctly that once someone notifies per Policy C notifies FDA of an intent to 
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distribute while they’re preparing the EUA or while the EUA’s being 

reviewed that it should show up under the FAQ page. Is that correct?

Dr. Timothy Stenzel: And this is a serology test or serology tests?

(Nikki): No it’s a PRC test (unintelligible) test.

Dr. Timothy Stenzel: I’m sorry 

(Nikki): I’m sorry it’s the diagnostic test the...

Dr. Timothy Stenzel: Is it a molecular test?

(Nikki): Yes, sorry yes.

Dr. Timothy Stenzel: Yes. I don’t know that we’re posting those. And I forget. Let me pull up 

the FAQ page right now. We probably are. And I’m - I know that we’re 

tracking them internally but I just do not remember...

(Nikki): Yes it’s under the question that says what commercial manufacturing or 

distributing test kits under the policy outlined in Section 4C of the policy for 

diagnostic tests...

Dr. Timothy Stenzel: Yes, yes.

(Nikki): ...for coronavirus disease.

Dr. Timothy Stenzel: Yes, and we’re listing those. So if we have not listed them yet please ping 

us at the EUA template and ask for them to be listed.
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(Nikki): Okay, thank you.

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

(Peggy): Hello. Yes my question is regard - in regard to home use serology test. As you 

noted Timothy, they are not - there are no home use serology tests that have 

received an EUA. And my question is can states override that because I have 

heard of a company in New York creating test kits that then gets shipped

across the country and then shipped back to them to do the testing but the 

collection is done at home. Is that allowed? 

Dr. Timothy Stenzel: So that is also a great question. It has not been to our knowledge 

something that the states are doing. And I was not aware that New York was 

doing that. We of course are working with states who are able to authorize 

tests and we will reach out to New York about that. But we would ask that 

developers of home use test that they reach out to the FDA. And then if 

there’s something that a state may be willing to do we can interact with that

state to make a decision.

(Peggy): Okay thank you.

((Crosstalk))

Dr. Timothy Stenzel: (Unintelligible) halfway.

Coordinator: Thank you. Our next question comes from (Frank). Your line is open.

(Frank): Hi, thank you. Just as a follow-up on the serology question regarding CLIA 

complexity. We have a lot of people telling us kits are being distributed with 

the understanding that these are moderately complex that actually waived tests 
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when we know that there’s only one test that’s been approved and that is only 

approved for moderate use. Is there going to be any type of notification to 

alert that at least the doctors’ offices that these kits are not being used in the 

proper settings?

Dr. Timothy Stenzel: Okay, we’ve point out some notifications already. I am not aware that we 

have said that they are currently high complexity. And so I will check into that 

and if we can we’ll make that more public. It is on our FAQ page though 

already.

(Frank): Well and the FAQ page has on one, question one says that the test is waived 

and on the second question it says that it’s high complexity. So a lot of people 

I think are getting confused because they look at the one answer and then they 

don’t go any further to look into it.

Dr. Timothy Stenzel: I agree. We’ll try to resolve the confusion on that Web site.

(Frank): It is a possible can we use third party approvals, a third-party review to review 

a submission for a serology test? 

(Frank): Wow that is a fantastic question. That’s the first time I’ve gotten that question. 

I do not know if we’re using third parties for EUA. We - I will address that. I 

will look into that question on my next quick address which I have about three 

or four of a week now.

(Frank): Great, thank you.

Dr. Timothy Stenzel: I will include that in many of them and if we can update our Web site

we’ll do that okay. Well alternatively you can also go to the email address and 
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ask that specifically you get that specifically address but that’s a great 

question.

(Frank): I’ll do that. Thank you.

Coordinator: From (Abby), your line is open.

(Abby): Hello.

Dr. Timothy Stenzel: Hi.

(Abby): I was just curious I noticed that on the Frequently Asked Questions page the 

FDA is now recommending phosphate buffered saline pacifically over normal 

saline. Do you have data or bridging studies to show its superiority and if so 

do you have a specific formulation of PBS that you’re recommending?

Dr. Timothy Stenzel: I think we provided a couple vendors with a PBS and/or an equivalent if 

I’m correct. Normal saline will work it’s just that our thoughts are that if a 

buffered saline could be used that that is probably preferable but normal saline 

is still allowed.

(Abby): Okay, we did have - we’re a manufacturer and we had some of our customers 

say that their saline studies weren’t as efficient as their PBSF. So I did know if 

you had a recommended formulation. But I’ll look at those ones that you have 

listed.

Dr. Timothy Stenzel: Okay.

(Abby): Okay, thank you.
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Dr. Timothy Stenzel: Thank you.

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

(Margot Enright): Hi. This is (Margot Enright) PTS diagnostics. In my question is if two 

subsidiaries of the same larger company, two smaller subsidiary desire to 

market the same or similar test do both of them need to file an EUA followedup by the 510K or just one of them file it?

Dr. Timothy Stenzel: Well is at the same test or different?

(Margot Enright): It’s one is manufactured outside the US and the other will be manufactured in 

the US. So there’s different manufacturing sites and the raw materials may 

come from different sources. 

Dr. Timothy Stenzel: Can - oh that’s interesting. I’m not aware of listing two manufacturers. 

That’s best addressed to our templates email address to be certain. I don’t see 

necessarily issues. We would again, you’re going to seek EUA authorization 

for these? 

(Margot Enright): Yes, one of them is already - one of the subsidiaries has already filed and...

Dr. Timothy Stenzel: Okay.

(Margot Enright): ...our subsidiary has not filed. And our question was since typically you can 

only have one 510K on the same product is at the same as for an EUA or is 

the - does the difference in the manufacturing site being US and having 

different source of raw materials does that make it a different product and 

should we file our own EUA?
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Dr. Timothy Stenzel: You know, I don’t know the best answer to that. I mean I would think that 

there would be easy routes to go through if it’s the same design manufactured 

in separate places. It actually may just be a paper question of who’s the legal 

manufacturer. If it needs to be two different EUA’s the one entity can refer to 

the data in the first entity’s package and basically submit a shell is what I’m 

thinking. But I would want to confirm all of that with our staff.

(Margot Enright): Okay thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Brandt). Your line is open.

(Brandt): Hi. First I want to thank the people who man the 24/7 helpline. They are 

uniformly helpful and patient and great. I want to go back to follow-up on 

(Frank)’s questions about serology tests. Just to be perfectly clear if we look at 

the (Selex) EUA and now apply this statement to all of those under the 

notification arm it says testing is limited to the laboratory certified under 

CLIA. So is it fair to say that if you’re in the notification arm and you have a 

test kit it can only be used in laboratories, that a physician cannot get the 

blood and do the test and interpret the test for the patient unless the physician 

is in a laboratory or associated with the laboratory certified as moderate or 

high complexity?

And in another part I was informed that -- and I just want to verify -- capillary 

blood finger sticks are not allowed. And is that put anywhere in big bold type 

you cannot use finger sticks? Thank you.

Dr. Timothy Stenzel: Okay, well regarding the single EUA authorization for serology that we’ve

granted that was designated by us as suitable for a moderate or high 
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complexity environment but not a CLIA waived environment so we did not 

deem it as waived. It’s my understanding the CMS requires a certificate no 

matter where the testing is performed even if it is a CLIA waived test there 

must be a certificate of CLIA waiver in order for the test to be performed even 

a CLIA waived designated test to be performed in that setting. And so that is 

coming, that’s our understanding what CMS opinion is on this. I would refer 

any questions to them though on this.

As far as capillary, so going back to the notification path for serology test that 

could potentially be used in point of care and could potentially have capillary.

It is because we again because we have not authorize these under an EUA we 

cannot deem them as CLIAs and therefore they revert to high complexity 

tests. And as far as the use of capillary is concerned capillary or finger stick 

blood as long as tests are validated and for capillary they could be used even 

in a high complexity type environment.

A high complexity lab could set up a finger stick station to be able to do these 

tests under their high complexity certificate. Again these test should be 

validated for capillary. If a developer wants to have a point-of-care test for 

serology or another test - well it would be serology here. We utilize a finger

stick. That’s an acceptable sample type as long as it’s been validated and then 

be used in that CLIA waived environment and we authorize it, we review the 

data and we are able presumably we’re able to deem it as a CLIA waived test. 

So hopefully that address your question.

(Brandt): Thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Kevin). Your line is open.
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Dr. Timothy Stenzel: Hey (Kevin). 

(Kevin): I’m with a kit packing company called PAP Tech. And as you know there’s a 

shortage of UTM around the country. I’m just wondering what is the FDA’s

stance on bringing in UTM from a foreign manufacturer that may not be listed 

or registered. Is there any kind of fast track process that we could get this 

authorized to bring it in?

Dr. Timothy Stenzel: That is a great question. If you have a vendor in mind and you want to 

have us make this determination if you send in that to our EUA templates 

address we will route that to the team that is working on alternate ETM 

sources. And also they aid in importation of such and they can address this 

question specifically.

(Kevin): Okay thank you so much.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Next question comes from (Ethan). Your line is open.

(Ethan): Yes, it’s a follow-up question from a previous caller. So my question is if we 

use the serology test at an appropriate site - I’m out here in California working 

with the local public health trying to expand increasing our ability to have 

more testing sites. Will we be able to use telehealth for the physician consult 

given that the serology tests are least for the ones that are not EUA are 

approved to be used for diagnosis? You know, I’m just kind of concerned how 

we can kind of increase our resources and also limit exposure?
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Dr. Timothy Stenzel: So we have not yet authorize the serology test as a sole basis of diagnosis. 

There are scientific challenges with that although if a developer wants to 

pursue that we will certainly engage in conversation. But obviously before 

antibodies are developed to SARS CV-2 the patient can be infected and that 

also antibody tend - antibodies tend to persist for long after an infection. And 

so they can be antibody positive but be completely cleared of the virus.

As far as telehealth or alternate sites or home use if something is within - is 

deemed as CLIA waived because it has been authorized by the FDA and it can 

be used therefore in a CLIA waived setting it that setting is going to be staffed 

by health care folks who are able to perform that testing. Usually telehealth 

would be used in more of the home situation and those as we stated before 

require EUA authorization for a home-based test. We are very open to a 

home-based serology test. The important factors are, you know, how easy for 

this a patient, untrained patient to perform the testing? How easy is it to them 

to read the test results and how easy is it for them to interpret those results?

Now for a typical rapid serology test there’s questions in each of those places 

and also we do look at safety. But we are very open to telehealth especially 

with a video link to assist patients in performing a serology test at home, 

reading the results of the serology test and then also interpreting the results for 

what it means. Hopefully that addresses your question.

(Ethan): Thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Mehti). Your line is open.
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(Mehti): Yes hi. Firstly, thanks for your time, your efforts and all the great info you’re 

providing. This is really useful. If I heard it correctly you mentioned that 

you’re porting a panel of positive and negative plasma together. Is there 

something that the serology assay developers are going to have access to or 

this is for FDA to try the kits that developers are submitting?

Dr. Timothy Stenzel: So this is an interagency program involving multiple agencies. We are 

collaborating on this. The first priority is to be able to collect enough of these

samples to be able to test at a central lab various tests that can be sent to this

facility. If you’re willing to participate you can email us at their EUA 

templates address and volunteer to be a part of that. We are hoping that there 

will be enough remaining plasma and/or sera to develop panels that we could 

send to developers. So at this point it’s probably best to stay tuned. If there is 

such panels that can be shipped to developers we will make that publicly 

known.

(Mehti): Right, thank you.

Dr. Timothy Stenzel: You’re welcome.

Coordinator: Thank you. Our next question comes from (Marcos). Your line is open.

(Marcos Lopez): Hi. My name is (Marcos Lopez). My question is about the serology test 

specifically the ones that are just going through the notification step. The 

thing is I’m representing a couple of clinical labs and I don’t know if you guys 

are aware but here in Puerto Rico we have noticed that a whole bunch of 

different distributors not even related to the medical field are bringing a whole 

bunch of the serology test. And since we have a really big shortage of the 

molecular testing now we have a whole bunch of companies selling different 

serology tests.
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Thing is that my question is we know that we have a whole bunch of 

companies that have been selling kits in Puerto Rico since the beginning of 

March. However what we are - the situation that we have is that if those 

companies have not been notified to FDA by that time since and the clinical 

labs already have this testing and they were issuing reports and things like that 

to people and we even have some positive patients do we need to go to those 

patients again and tell them, “Hey, your report isn’t invalid because probably 

this company has, you know, did not notify FDA and it was not - the company 

was not allowed to commercialize the kit by that date?” And I mean the 

follow-up will be can you tell us the exact date that each of the companies 

were notified or okay to commercialize the serological test through this route 

in the Web site or something? Hello?

Dr. Sara Brenner: Hello? Tim, are you there?

(Marcos Lopez): Tim?

Dr. Sara Brenner: Operator are you there?

Coordinator: Excuse me this is the operator.

((Crosstalk))

Coordinator: It looks like his line is disconnected. I will give him a call back moment 

please.

Dr. Sara Brenner: Thank you.

(Marcos Lopez): Okay.
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Dr. Sara Brenner: This is Sara. I can pick up for a minute until Tim is able to rejoin us. So that is 

an excellent question and a very challenging couple of questions and we’re 

working as quickly as we can with our partner agencies to try to figure out 

how to assist with essentially figuring out which serology test will be best for 

folks and with the realization that many have already been rolled out.

(Marcos Lopez): Yes, but the thing is what we really want to do I mean we already issue a 

whole bunch of reports.

Dr. Sara Brenner: Yes.

(Marcos Lopez): But what we really want to know is that, you know, we know that some of the 

companies because now there is a big situation in Puerto Rico going on about 

companies that were not related to (unintelligible) that were bring in this test 

to Puerto Rico.

Dr. Sara Brenner: Yes.

(Marcos Lopez): And we know or we suspect that probably some of this test are were brought 

into Puerto Rico and they were not tests that are already from - or companies 

that already notify FDA by the date we were - they were purchased by clinical 

labs. So the question will be, you know, can we get in the Web site that they -

that this company were okay to start commercializing the test in the US? And 

the second will be should we - I mean if we check that the company the kit 

was sold before the notification okay that will be like an illegal thing probably 

not related to the company manufacturing the kit but for to - these other 

people that are...

Dr. Timothy Stenzel: This is Tim. I’m back on. Can you hear me?
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(Marcos Lopez): Yes.

Dr. Sara Brenner: Yes, we can hear you Tim. So there...

((Crosstalk))

Dr. Sara Brenner: ...was a question and a related question on serology tests that rolled out in 

Puerto Rico starting in early March that had not notified the FDA.

Dr. Timothy Stenzel: Yes.

Dr. Sara Brenner: So how to handle those results that...

Dr. Timothy Stenzel: Yes.

Dr. Sara Brenner: ...have already been reported to patients?

Dr. Timothy Stenzel: Yes, that’s an off-line question I think. So if you send an email to cdrheua-template at...

(Marcos Lopez): Okay.

Dr. Timothy Stenzel: ...fda.hhs.gov with that question and ask that, I or Sara be involved will 

work with you to resolve that issue okay?

(Marcos Lopez): Thank you. Thank you, appreciate it.

Dr. Timothy Stenzel: You’re welcome.
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Coordinator: Thank you. Our last question comes from (James). Your line is open.

(James): Yes hi. I have a question also on serology Pathway D looking at the 

opportunity to set up a US-based production facility. And I noticed in the -

one of the recent approved EUAs that the GNPs were waived. And I was 

wondering if there was further clarification on what that meant or will there be 

further guidance issued on that?

Dr. Timothy Stenzel: Yes, so under an EUA to waive any of the GNP requirements. One 

important element that must be retained is that you have a complaint handling 

system and adverse reporting, adverse event reporting so that your monitoring 

the performance of your tests on the market and if there are issues and you’re 

required to report from the FDA that you do report in a timely way to the 

FDA.

If you look at any of the decision statements on our FDA Authorization Page 

you will see what provisions are waived. I don’t have them off the top of my 

head but if you look at those you will see what provision of GNP and CFRs 

are waived in an emergency situation. And if that doesn’t address your 

question well enough you can come back to our EUA templates address and 

we’ll answer any further questions.

(James): Thank you. I also was wondering if you guys have sources for bulk COVID19 protein antigen for the serology test? Is that an effort being pursued by 

government agencies with a private partnership?

Dr. Timothy Stenzel: So I know that we are trying to obtain some of those for our own internal 

interagency work but at this time we don’t have plans to distribute that. Those

are usually proprietary. I know that there is at least one entity out there that is 

publicly announced that they are willing to transfer their serology tests to 
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others so you can certainly look at those public announcements and reach out 

to them.

(James): Thank you.

Dr. Timothy Stenzel: And if you - and I don’t want to publicly state their names just because I 

want to be fair to everybody so okay?

(James): All right.

Dr. Timothy Stenzel: All right.

Coordinator: Thank you. That was our last question. Irene I’ll pass it back to you.

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

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

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

by Monday, April 13. If you have additional questions about today’s 

presentation please email cdrh-edu-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/cdrhwebinar immediately following the conclusion of today’s 

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

discussion.

Coordinator: That concludes today’s conference. Thank you for participating. You may 

disconnect at this time.
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END