FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 1

FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus 

(COVID-19) Diagnostic Tests

Moderator: Irene Aihie

April 15, 2020

12:15 pm ET

Coordinator: Good afternoon and thank you for standing by. As a reminder, today's 

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

this time. Your lines are on a listen-only mode until the question-and-answer 

session of today's conference. At that time you may press star followed by the 

number 1 to ask a question. Please unmute your phones and state your first and 

last name when prompted. It is now my pleasure to turn the conference over to 

Irene Aihie. Thank you. You may begin.

Irene Aihie: Thank you. Hello. I'm Irene Aihie of CDRH's Office of Communication and 

Education. Welcome to the FDA's fourth in a series of virtual town hall 

meetings to help answer technical questions about the development and 

validation for tests for SARS-CoV-2 during the public health emergency.

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

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

provide a brief update. Following his remarks we will open the line for your 

questions related to today's discussion. Now, I give you Timothy.

Timothy Stenzel: Good day. Welcome again to this town hall. Thanks to everyone involved in 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 2

responding to this pandemic. We are in this together and together we will see 

our way through it. We at the FDA as everyone else in our field are keenly 

interested in doing what we can to accelerate a return to normalcy.

I've witnessed amazing collaborations and sacrifices today to get to where we 

are today. And I know that additional collaborations and sacrifices will need to 

be made to get all the way through. So thank you so much for what has been 

done so far and thank you in advance for everything else that's going to happen.

My hat also goes off to the great staff here at the FDA. Our template email 

address, for example, has seen tens of thousands of emails to date and our 

backlog however of unresponded emails is incredibly small. Still, we are 

adding staff to even more quickly address questions.

Okay. Moving into updates. Yesterday we authorized five new EUAs including 

two serology essays, chem-bio and ortho-clinical. We also this week have 

authorized our first saliva EUA. I will address saliva in more detail in just a few 

moments.

Next, I would like to move into key safety messages. This may be as required a 

regular part of this town hall going forward. First up and these are going to be 

addressed in various ways either by manufacturers or on our FAQ page. We've 

heard about safety issues relating to the use of Guanidine containing transport 

media such as the prime store NPM with the Hologic Panther System. We 

advise against use of this transfer media as it can produce potentially toxic gas.

Second, for use and for specific about the Abbott ID Now Test. Abbott will be 

updating its labeling and instructions to remove the use of VTM with this test. 

The test works as intended with a direct simple use. Customers will be notified 

to not use VTM.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 3

So we've heard of issues with VTM and appears to be primarily a delusional 

issue that reduces the sensitivity of the essay.

I will address potential issues like these going forward and how you can notify 

the FDA. Of course, you can always notify the manufacturer when you 

experience problems.

Okay. As I just mentioned we do want to hear about potential issues with test. 

Please use the online FDA MedWatch System. You can simply Google 

MedWatch (M-E-D-W-A-T-C-H). It's an easy online report. You will review 

these issues in a timely manner and address them as soon as we can.

Second, home collection. While we look forward to authorizing the first home 

collection we have not done so yet. I think there may be some media reports 

otherwise. But to date we have not authorized home collection but we do think 

that it's going to happen very soon in a number of different situations.

Home testing. Likewise, we have not authorized a home test and there may be 

some confusion out there. We look forward to authorizing the first home test 

and are actively working as with home collection with a number of developers.

Saliva. Saliva remains a very interesting sample type. Obviously relatively easy 

to collect. Doesn't require any use of a swab which is sometimes in short 

supply. To date we've only authorized one saliva collection device for use with 

this specific test. The performance was quite excellent and we were pleased to 

see that excellent performance and the comparison between either 

Nasopharyngeal and Oropharyngeal swabs and the saliva.

This was used at (Rikers) where they have a particular selection device for the 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 4

use in a health care setting under observation. As well as the (unintelligible) 

coupled to thermal fisher ATPCR reagent. So this is somewhat of a hybrid 

authorization.

To date we have seen otherwise quite variable results with saliva. We don't 

know exactly why. This could be a sample stability issue. But we clearly see 

that at least in one case this works. Whether this is a combination of particular 

devices or it's resulting from the use of a device that may stabilize the viral 

learning immediately. We do not - you had known yet.

But we look forward to authorizing additional saliva collection options for 

developers. So if you are interested in saliva we do want to see those as EUA 

submission. This is a new sample type and we want to make sure that we 

address the variables seen in some devices and some uses and can assure that 

quality results are achieved.

Serology. So we continue to seer problematic claims and uses of serology tests 

particularly those that have been listed on our FAQ page under Pathway D. 

These devices are only for high complexity labs. They are not to be used with 

moderate complexity labs or in point of care near patient settings nor in a home.

None of these have been - that are currently listed on our Web site have been 

authorized by the FDA except the three serology essays that I previously 

mentioned. We are looking for ways to additionally make this very transparent 

to as many people as possible.

Next on serology. Serology specificity is highly important as there are potential 

uses of the result of this testing we inform important decisions and specificity, 

in particular, is important.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 5

False positives might lead somebody to believe that they are immune when they 

are not. Therefore there are significant risks in interpreting the results of the 

serology test.

We are looking for ways to additionally highlight these concerns and stay 

tuned.

I will just point out that even with a test that is highly specific if the prevalence 

of immune persons in a population is relatively low and we don't know the 

exact number right now or the percent of our population. Then the setting of an 

incredibly low prevalence even a very specific test can have a number of false 

positives and the positive predictive value is relatively low.

So again we will look for ways to further educate and inform all concerns about 

these issues so stay tuned.

Next I wanted to address some previous questions from last week and try to 

provide some more general clarity.

One question we had, have we authorized any tests molecular or serology for 

use with a deceased person? No, we haven't. Manufacturers should seek such 

authorization if they are going to address claims.

And that clear lab as I said last week they can validate this sample type if they 

so choose as long as it’s already a previously authorized for general use sample 

type. So we would also say that probably a nucleic acid test is collected soon 

after passing would be better than a serology. Obviously post mortem blood 

tests are challenging.

If there are samples - serology types sample - plasma serum it's available 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 6

immediately prior to death that was draw clinically, that may be a good sample 

type to use for such serology testing.

Next question was, will the FDA review quantitative serology tests? Yes, we 

will. Can we follow Pathway D? I would ask that you come and talk to us if you 

wish to follow Pathway D and you have a quantitative test claim.

Next question, are labs developing their own serology tests required to validate 

isotype? Through Pathway D labs simply can notify us once they have 

validated their serology test and a submission is not required. We do 

recommend that you do validate isotype if you are claiming and reporting 

results by isotype.

Next question is, can third party reviewers review EUAs? Unfortunately, no. 

Right now that is not a pathway that we are allowing and we would ask that 

EUAs come in through the FDA.

And finally, there was a question about what to do with serology tests that were 

authorized to allow through Pathway C or D prior to notification? You can 

reach out again to our templates email address.

Also I would like to make aware - all aware of our FDA fraud line or fraud 

email. If you have concerns about fraud or misrepresentation you can email us 

at FDA-COVIDBOVID-19-FRAUDULENT-PRODUCTS@FDA.HHS.GOV 

and that will - an email address will be in the transcript to follow.

Okay. At this point I have completed my preliminary remarks and I would ask 

to turn this over to Dr. Sara Brenner for some remarks and comments by her 

before we open the lines for questions and answers. Thank you.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 7

Dr. Sara Brenner: Great. Thanks Timothy. I just wanted to follow up on a thread that was opened 

last week on collaboration with stakeholder communities. And I think those 

who did reach out who voiced questions on the line last week and then followed 

up with emails I have been able to have conversations with quite a few folks and 

brainstorm on how we can take a whole of the community approach to 

expanding testing and improving the quality of testing.

So I just wanted to again welcome folks to reach out whether you are from a 

university, academic medical center or laboratory or test developer. We're 

being very creative in terms of looking at ways that we can work together on 

this. Timothy mentioned in improving test quality, expanding our testing 

capacity across the U.S and also report and track the results that are coming 

forth.

So that's sort of a second topic under that umbrella that I wanted to mention that 

we're looking at quite intensively now and that is how to track data that has 

been reported from tests that are being performed at a both molecularly and 

increasingly serological so that we can gain a better understanding of 

prevalence of the disease and its clinical course over time in specific regions.

And I would envision that as sort of three different tiers of diagnostics. Data 

one, at the national level that's used by decision-makers who are making broad 

sweeping national decisions.

The second, level of granularity at the state or local level that will help local 

decision-makers.

And then a hyper-local or even individual clinician and patient-level set of 

information that includes things like comorbidities, other specific Electronic 

Health Record components for each patient that can help us better understand 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 8

how accurate the testing was and follow the patient's clinical course through 

time.

So we would be asking for your input, thoughts and collaboration on those 

aspects that help us harmonize data and use it clinically as well as understand 

from an epidemiological standpoint how the course of the pandemic is 

progressing and how that can inform good science-based and evidence-based 

decision making at every level.

The last topic that I want to mention which I think was mentioned before in 

these town halls is a community engagement strategy around manufacturing, 

makers and folks who are trying to contribute in different ways to supply - to 

address supply chain shortages.

One topic that we've been spending a lot of time on here in our office is 3D 

printed Naospharyngeal swabs. So that's just one example of a type of a product 

in the IDD pipeline that folks are trying to get creative around manufacturing or 

creating for local use.

So if you have those sort of thoughts, ideas or capacities that you are trying to 

build up and you are looking to engage with FDA for guidance and direction 

please go ahead and reach out to us.

So I'll stop there and turn it back over.

Timothy Stenzel: Thanks Sara. Okay. We can open it up for questions and answers.

Coordinator: Thank you sir. At this time if you would like to ask a question or if you do have 

any comments, please unmute your phones and state your first and last name 

when prompted by pressing star 1. Again that is star 1 for any questions or 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 9

comments...

((Crosstalk))

Coordinator: Our first question comes from (Grant Metler). You may go ahead, sir.

Brant: Thank you. That's Brant (B-R-A-N-T). Mr. Stenzel, yesterday a CNN report by 

Elizabeth Cohen as senior reporter said that I quote, "On March 16 the FDA 

loosened its standards and allowed companies to sell antibody tests without 

submitting any evidence that they worked." I hope that you can dispel that 

myth. But the article also talked about testing the products and I presume that's 

a serology product. Now I have previously enquired of the FDA about the 

Voluntary Submission Program which you mentioned last week. The response 

to my query was, here is a release form send 125 test kits. My question is, will 

you also publish the protocol - the testing protocol and how exactly the test kits 

are going to be tested? Thank you.

Timothy Stenzel: Thank you Brant. So to address your first question or comment, we through 

Pathway D we allowed test developers who had validated their test for the 

intended purpose reporting our IGM and IGG and or IGG or other serology 

endpoints that they could follow this pathway to certify to us and notify us that 

they had validated their test and that they could then receive confirmation from 

us and could market it in the U.S.

The requirement for this pathway is that these tests be validated properly and 

also that they attach the limitations - there is forming limitations and that these 

claims could not include sole use for diagnosis.

So there is obviously a standard here that must be adhered to. If that standard is 

not followed, if a developer has been transparent with us that would result in 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 10

potential consequences.

So the other important feature is that the formal EUA process is also to be 

followed - I mean it also can be followed and that is a fully EUA authorization 

pathway and for FDA EUA authorization.

In addition, the Pathway D notify develop - notification for developers they 

intend - these are intended for high complexity labs in that environment high 

complexity labs can assess whether or not these tests on their own their 

performance can be verified. So we believe that with all these controls that we 

can ensure that only accurate results are reported back to clinicians and patients.

Second, the Voluntary Testing Program that has been mentioned in multiple 

forums now by multiple officials is active and we invite all developers who 

have an appropriate device to come in.

If you have specific questions about testing protocols, those individual

developers as they consider whether or not they want to be a part of this 

program can enquire for more detail.

At a high level we are trying to determine whether the results that come from 

these tests with patient samples can be relied upon and can have a level of 

accuracy that indicates that these are fit for use in the United States.

We also are looking at an alternate pathway for EUA authorization when 

participants have participated in the program and more details to follow.

Thanks so much.

Coordinator: And thank you. As a reminder that is star 1 if you would like to ask a question. 

Please limit all questions to one question. Thank you. Our next question comes 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 11

from Alice Jones. You may go ahead.

Alice Jones: Good afternoon. Thank you. I wanted to ask a question about the requirement 

for the sterile scissors that's noted in several of the manufacturer's answers and 

or CDC Web site? So obviously I think the concern there is bacterial 

degradation of the RNA from a nonsterile cutting implement if you will. 

However, there is bacterial inherent in the sample collection process. So my 

question is truly the impact of using nonsterile scissors to cut the swab to be 

able to place it into the transport media.

Timothy Stenzel: Sure. So some media has obviously has inhibitors of growth of unintended 

organisms. Also overgrowth of unintended organisms can degrade the sample. 

So I would advise that where possible to follow the instructions as indicated and 

to the best of your ability. I think Id o realize that we are in real-world situations 

here and I would just ask you do your best to follow those instructions.

Alice Jones: Okay. Thank you very much.

Timothy Stenzel: You're welcome.

Coordinator: Thank you. And our next question comes from (Peggy Magloplin). You may go 

ahead.

(Peggy Magloplin): Good morning or good afternoon. I actually have two questions. One for Dr. 

Stenzel and one for Sara. Dr. Stenzel, can you speak to the state allowances in 

regards to testing as opposed to the FDA allowances because that is very 

confusing for the general public. And Sara, you had mentioned if folks are 

working on activities that could assist in tracking et cetera to reach out to you, 

could you be more specific as to whom and what email should be used for that? 

Thank you.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 12

Timothy Stenzel: Sara, do you want to start and I will finish?

Dr. Sara Brenner: Sure. Yes. So you can just email me sara (S-A-R-A).brenner B as in Blue -

R-E-N-N-E-R@FDA.HHS.GOV and I look forward to answering any of your 

questions related to that going into more detail.

Timothy Stenzel: And (Peggy), you can call me Timothy. Yes, as far as state allowances go so we 

have allowed states to authorize LDT tests for labs within their state 

jurisdiction. This is limited to LDTs in high complexity laboratories. One such 

program is obviously well-established sort of program is New York State which 

has been reviewing LDTs for a number of years prior to - for labs in their state. 

So they are well experienced.

We have not specified how states decide how to authorize these high 

complexity LDT developed tests. We do leave that to the state.

Labs within those states are still allowed to come into the FDA for EUA 

authorization. There are certain situations where those are required such as 

home testing or home collection. Also the particular devices that might be used 

such as saliva collection we would - and new sample types that haven't been 

authorized prior to the FDA- previously by the FDA or where we see a broad 

generalized applicability of our sample type we would ask that they come in as 

well.

And we are also - I'm very open to working closely with each and every state 

that wants to do this and support their programs in any way we can to address 

any questions that we can.

So hopefully that further clarifies and potential issues there.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 13

Coordinator: Thank you. And our next question comes from (Shawn Dowen). You may go 

ahead.

(Shawn Dowen): Hello. Could you please tell me what is the FDA's preferred coding language? 

What is the common medical oriented language (COMOL) as it were for 

medical devices or biomedical diagnostic devices?

Timothy Stenzel: (Shawn), I'm not sure I understand your question.

(Shawn Dowen): Should I be coding in C, THP, Python, Rubi, SQL?

Timothy Stenzel: Oh. Okay. Okay. Software coding. I don't believe we have a preferred method. 

We have a very experienced software review team and we are just looking for, 

you know, great software to be able to - and working with great software 

developers to address concerns. But to my knowledge we don't have a preferred 

platform.

(Shawn Dowen): In that case...

((Crosstalk))

Dr. Sara Brenner: (Shawn), this is Sara. If you want to follow up with me I can help route that 

question. One of the related interests that we have is data sharing and open EPIs 

and that sort of thing. So I would be happy to route that question if you want to 

reach out after the call.

(Shawn Dowen): Okay. What is your contact information, Sara?

Dr. Sara Brenner: It was as previously given my name sara.brenner@fda.hss.gov.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 14

(Shawn Dowen): Okay. Thank you very much miss and to you too Timothy. Got it.

Coordinator: Thank you. And our next question comes from (John Norris). You may go 

ahead, sir.

(John Norris): Thank you. Hi Timothy and Sara. I'm a former Albert family member 

specializing in health policy and management and my course is sometimes 

assessed FDA health policy. In recent years actually since 1987 I have been an 

advocate around the world for fully-at-home infectious disease testing similar 

to devices used currently at home for diabetics to assess their blood sugar level.

Yesterday - excuse me, I published an open letter to the President advocating 

Fully-At-Home massive testing in the Coronavirus case. Excuse me. I intend to 

write you a letter today assessing or criticizing and supporting various aspects 

of current FDA policy related to fully-at-home testing. And I'm just saying this 

today because I hope you will take the letter in the spirit it's intended. Thank 

you.

Timothy Stenzel: Absolutely. We welcome all input and we take it all seriously. We are very 

interested in home collection and in home testing. And we are working with 

multiple parties and hope to authorize the first ones very, very shortly. So stay 

tuned.

Next question?

Coordinator: And our next question comes from (Shelly Fair). You may go ahead.

(Shelly Fair): Good afternoon and thank you for taking my call. I have a question in regards to 

quality systems and the quality program expected between an IDE and an 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 15

emergency use authorization. So the emergency use authorization guidance 

states that a quality system or parts of the quality system can be waived by 

FDA. However, IDE states that for a medical device development you should 

be following A20.30. So I just like clarity on do we need if we have a product in 

IDE study right now but the intent is to bring it forward as a emergency use 

authorization do we need to follow all of A20.30 or is there flexibility with the 

manufacturing especially when it coming through an academic institution?

Timothy Stenzel: Okay. Good question. I want to just repeat the question back. You want to know 

what are the IDE requirements when considering the EUA situation.

(Shelly Fair): That's correct because in some ways it seems as though to get a product or using 

a product with a IDE or brigaded IDE it's more stringent to follow all of A20.30 

versus well, there could be complete flexibility or whatever level of flexibility 

when it's emergency use authorization. I would just like clarity as to what 

happens if we have a manufacturer that cannot follow all of A20.30 but still we 

would like to move the product forward to an emergency use situation.

Timothy Stenzel: So we work on a high, you know, even prior to this emergency with a number of 

different entities that have significant risk devices that they require IDEs and, 

you know, that from academic institutions to RND organizations and obviously 

not just fully compliant IDT manufacturers. So we found a way to work with 

all. The primary concern for which they require an IDE are is there are 

significant risks involved and are those risks mitigated in any way.

So, you know, for those devices in this case with limited test where there might 

be significant risks and you can come to us through our templates email address 

- ERA templates email address and we will discuss with you whether or not an 

IDE may be required.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 16

But for tests I could be wrong but I'm not sure that we've had a situation where 

that's been addressed. But - so you may have specific considerations that are 

specific to your development or intended development that maybe is best 

handled offline. But overall we want to do the right thing in regard to significant 

risk situations.

Coordinator: Thank you. And our next question comes from (Hanna Fish), you may go 

ahead.

(Hanna Fish): Hi. Thank you. I think this might have been addressed in an earlier question but 

I just wanted to get clarification with regard to the voluntary program with the 

NR agency review of the serologic test (unintelligible). Can you now elaborate 

on what that review process is and how that information is going to be made 

available to the public and what we can expect as far as review of complexity of 

those tests?

Timothy Stenzel: Sure. This is primarily intended for rapid serological tests. It is an interagency 

program that's designed to do testing with actual patient samples.

Voluntary program, we have yet to decide on how this - the result of this may be 

formally made public. We will, you know, situations work with individual 

developers on that.

The sort of regulatory review of any data that may come out of this is going to 

reside with the FDA. So if a sponsor would like to - test developer would like 

for the test results from this interagency collaboration to be used for a formal 

submission to the FDA that is going to be entirely possible and we'll work with 

- the FDA will work with those individual developers to determine how that 

would happen.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 17

We are working on further announcing how that potential pathway so stay 

tuned that should be forthcoming in the not too distant future.

Coordinator: Thank you. And our next question comes from (Elizabeth Ora). You may go 

ahead.

(Elizabeth Ora): Hi. I was wondering, is there a process to remove tests authorized via EUA 

from the market if they are found to be ineffective or dangerous?

Timothy Stenzel: So there is a way to do that. We are fully are willing to deny an EUA 

authorization if on your review we cannot establish that there will be accurate 

testing. And if we determine that a test in the market is not performing I 

mentioned earlier the MedWatch we will first and foremost reach out to a 

developer and initiate conversation. And we will together try to find the best 

way forward to ensure that there is accurate testing available.

At the beginning at the top of the call I mentioned an update about the Abbott 

ID Now, this exact pathway was followed. We had a conversation with the 

developer and together we decided, you know, we make decisions together on 

collaborative beyond on the best pathway forward. So that is our traditional 

way of handling these sorts of situations. We always first want to engage the 

developer to understand what the performance issues might be to try to 

understand what the root causes if there are in these performance issues. What 

the solution to those issues might be and what is the best way to address that as 

quickly as possible so that - for the benefit of the public health.

Hopefully, that addressed your question. 

Coordinator: Thank you. And our next question comes from (Paul Barto). You may go 

ahead, sir.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 18

(Paul Barto): Yes. Good afternoon. This is (Paul Barto) calling in from McKesson. Thank 

you for taking my call. Really, it's kind of a two-part question. So the first part 

is, I'm interested to understand how the FDA is considering a long term 

authorization for serology tests. So really once emergency use authorization is 

listed and the 510K rules are applied.

And the second question is, for these serology tests, are you anticipating them 

to be used in a professional environment with point of care designation so with 

the equivalence of a clear waiver?

Timothy Stenzel: Yes. Yes. That was a great question. So first of all the long term authorization, 

so I do not personally foresee this emergency declaration going away any time 

soon or we are talking at least years. Where a potential market situation may 

occur is if a developer comes in for full FDA authorization whether that's De 

Novo or some other pathway and gets authorized. The EUA law allows for 

other similar devices to no longer be covered by the UA. This is only done very 

carefully though because we always want to assure there is plenty availability 

of test in the market as perhaps, you know, a single manufacturer though 

performance may be excellent we want to address market access to everyone to 

ensure that adequate volumes and number of tests can still be performed.

So those decisions are made extremely carefully and the benefit risk of what we

do is always addressed and we always air on the side of ensuring adequate 

availability of testing.

Second is, the use of serology tests in the professional environment i.e your 

patient testing point of care came to a clear waiver. We have the ability to when 

we authorize an EUA or a test that's amenable for use in these settings to sole 

deem it through language in the authorization. CMS has generously agreed to 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 19

allow this process to occur. We are under the (unintelligible) any authorized 

test. We have provided a designation - a letter designation H for High, M for 

Moderate and W for Clear Waived or deemed clear waived in this case other 

than high complexity. And we are very open to reviewing tests for this.

Tests that come solely through the notification process of Pathway D are not 

available for this deeming. We can only deem when we are able to review and 

authorize the test through one of the existing for an EUA authorization 

pathway.

So hopefully I addressed your questions.

Coordinator: Thank you. And our next question comes from (Steve Sjkags). You may go 

ahead, sir. (Steve Stags), your line is open.

(Steven Stags): Hi. Good afternoon. Sorry about that.

Timothy Stenzel: Hi Steve. How are you?

(Steve Skags): Good. Thank you very much for this. I appreciate your taking the time to 

answer these questions. I had a follow up from last week that I haven't seen in 

the FAQs or I just missed it. We spoke about the co-validation effort being 

made that was happening with some or was planning to happen with some 

partnerships that the FDA was forging for serology tests particularly I think 

under policy D. I have not been able to find anything else out about that and I 

was curious if that was either still in the works setting it up or if I have just 

missed it.

Timothy Stemnzel: No. We have not made any formal announcements. We have reached out to 

all developers that have or should have - to all developers that have notified us 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 20

through Pathway D to invite them in to be participants in this. We have begun 

receiving test kits from at least some of these developers and we believe testing 

will begin in the very near future. And as soon as we can find a way to report 

results either through an EUA authorization or other means we will make that 

available. We also are working on a way to let the community know more about 

the details of this program.

But for now, we invite developers who want to be a part of this to send us an 

email at CDRH-EUA-TEMPLATES email address and we will connect you 

with the program and you can get all the details from them directly.

Coordinator: Thank you. And our next question comes from (unintelligible). You may go 

ahead, sir.

Man 1: Thank you for taking my question. Is the FDA or any other government agency 

providing a reference style for serology testing or maybe (unintelligible) 

development materials that can be used so what is the FDA or government 

doing to help serology essay developers in this particular case?

Timothy Stenzel: So to my knowledge such panels are not yet available. We have engaged with 

multiple parties to try to stimulate the development of these panels. We know 

that several commercial entities are looking into collecting patient specimens in 

the effort to address this need. We - as soon as such material is available for test 

development, validation and verification we will endeavor to make that 

publicly known on our FAQ page. But at the moment I believe they are still in 

development.

Coordinator: Thank you. And our next question comes from (Kassim Aleikum). You may go 

ahead, sir.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 21

(Kassim Aleikum): Yes. Hi. Thank you for giving me the opportunity of asking the question. I 

believe my question was just answered while (Paul) raised the question of the 

active 510k and the pathway for the point of care testing.

Timothy Stenzel: Okay. Any follow up questions.

(Kassim Aleikum): All right. Thank you. A follow-up question, yes, I was just discussing about 

this with our templates as well. When a company is filing for a serology E way 

under the section C what type of clinical performance study is required and is 

an IRB approval required for the clinical study if the specimens taken are 

retrospective study?

Timothy Stenzel: So we are working on templates for serology and we hope to make them 

available as soon as possible. You can - if you are interested in what our 

thoughts are about serology development and validation you can email us at the 

template email address and we can provide you with a draft document that we 

are working on or that we have already worked on. And also address any direct 

questions or follow up questions you have about that.

I'm sorry, what was the second part of your question?

(Kassim Aleikum): Is an IRB approval required when doing a clinical performance study?

Timothy Stenzel: So an interesting question. So I don't know that this is entirely within the FDA 

purview. First of all, I would address any questions with your IRB about 

whether IRB is required or, you know, if you are using residual de-identified 

clinical specimens whether a waiver of consent is required from your IRB. I 

think those your best - questions best handled by local IRBs.

I would say that traditionally when a commercial test developer develops a test 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 22

and is going to use such leftover patient material that getting an IRB 

authorization for the use in development of commercial products is at the very 

least wise.

(Kassim Aleikum): Okay. Thank you.

Coordinator: Thank you. And our next question comes from (Susan Sharp). You may go 

ahead.

(Susan Sharp): Sara and Timothy thanks both of you and your team at the FDA for everything 

you are doing to help us navigate through this crisis. Sara, this question is for 

you about the 3D printed swabs. Has the FDA decided for these swabs if they 

are going to be need to be made under GMP and have biocompatibility studies 

done before they are being able to be used in the population? Thank you.

Dr. Sara Brenner: Yes. Great question. And I think the answer that we're coming to is, yes. Yes for 

GMP sterilization and biocompatibility. We are actually working on an internal 

document to address other concerns with regards to the 3D printed swabs but 

that one is one that I think we are coming close to settling on.

(Susan Sharp): And will that information be up on the FAQ when those decisions are made?

Dr. Sara Brenner: I'm not if it' will be FAQs or how we will communicate that but certainly we 

will find channels. If you want to shoot me an email just so I can make sure to 

follow up with you specifically as soon as we're ready to release information I 

can do that.

(Susan Sharp): Thank you so much.

Dr. Sara Brenner: You bet.
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 23

Coordinator: Thank you. And our next question comes from (Maryanna Pegner). You may 

go ahead.

(Maryanna Pegner): Good morning and thank you for holding these town halls. My question is 

related to the availability of a template document. The one available for 

manufacturers on the FAQ page right now refers specifically to a molecular 

method. Are there other templates, other developments and when might we be 

able to see them?

Timothy Stenzel: So great question. We are finalizing templates for serology at this moment and 

we'll put them on our Web site as soon as possible. In the interim, you can shoot 

us an email ar cdrh-EUA-templates and you can get a draft recommended 

validation protocol.

Coordinator: Thank you. And our next question comes from (Jane Aya). You may go ahead.

(Jane Aya): Hi. Thank you so much. My question is for Dr. Brenner again related to the 3D 

printed Nasopharyngeal swabs. I'm wondering if there are any published FDA 

guidance or standards documents that are relevant specifically to the design and 

manufacturing of Nasopharyngeal swabs.

Dr. Sara Brenner: Yes. That's a great question and that's sort of what we are working on now. We 

are doing sort of a scientific structuring of what our recommendations would 

look like and the different to consider that will then go through policy, 

regulatory and legal review. So in terms of guidelines we do not have any that 

are public-facing yet at this point and we are aware that there are several 

different scenarios by which a 3D printed Nasopharyngeal swab, for example, 

might be created including the entities who are involved in the designing of 

more of the software side, those who are actually in the manufacturing world 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 24

either in a small way for local distribution or distribution with another 

institution. And then potentially commercial entities who would be producing 

at high volumes and distributing. So each of those entities will have some 

responsibility.

But on the design side that you asked about we are trying to figure out what the 

role of us and our collaborators and partners for example through the MOU 

with NIH and VA and American Mates would be with regards to helping to vet 

the designs themselves. So stay tuned for information forthcoming on that. And 

if you would like to email me directly please do and we can keep you looped in 

as that conversation evolves.

Coordinator: Thank you. Our next question comes from (Harry Davity). You may go ahead, 

sir.

(Harry Davity): Thank you Timothy and Sara for all the work you guys are doing. My question 

has been answered. Thank you.

Timothy Stenzel: You're welcome.

Coordinator: Thank you. And our next question comes from (Jennifer Stockmann). You may 

go ahead.

(Jennifer Stockmann):Hi. Thank you. I have a question about your initial remarks regarding 

potential safety concerns with the prime store tube as well as the use on the 

Hologic Panther System. I was wondering if you could provide more 

elaboration on there as well as is there any documented guidance with regard to 

this product and additionally what the findings were?

Timothy Stenzel: Yes. So we're going to update our FAQ page with a warning. It turns out that 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 25

there us bleach used in the process in the Hologic Panther System and bleach in 

combination with Guanidine can produce cyanide gas.

(Jennifer Stockmann):And then is that interaction specifically between that product and that test

only?

Timothy Stenzel: That is the only one that we are currently aware of. We are looking across all 

authorized manufacturers to see if we need to update that. So that's our existing 

up to date knowledge as of today.

(Jennifer Stockmann):Thank you.

Coordinator: Thank you. And our last question comes from (Brianna Hawkins). You may go 

ahead.

(Brianna Hawkins): Hi. Thank you for taking my call and my question. My question is do you 

anticipate having a template specific for rapid imaging detection test i.e lateral 

flow essays or detection of virus?

Timothy Stenzel: Yes. That's a great question. So we're spending a lot of time right now on 

working with developers of serology test and that's the current wave of new 

development. We see that rapid imaging direct detection lateral flow rather 

point of care type tests are going to be coming soon and we've already begun

working on to find a lead on developing the template for that category of tests.

Coordinator: And thank you. I would now like to turn the conference back over to Irene 

Aihie.

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

questions. Today's presentation and transcript will be made available on the 
FDA Virtual Townhall

Moderator: Irene Aihie

04-15-20/12:15 pm ET

Page 26

CDRH Learn Web page at www.fda.gov/training/cdrhlearn by Monday, April 

20. If you have additional questions about today's presentation please email 

cdrh-eua-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 fda.gov/cdrhwebinar immediately following the 

conclusion of today's live discussion.

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

Coordinator: Thank you for participating on today's conference call. You may go ahead and 

disconnect at this time.

END