FDA Webinar 

Moderator: Ivory Howard

09-29-20/12:00 pm ET 

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FDA Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for 

Health Care Personnel Use During the COVID-19 Pandemic

Moderator: Ivory Howard 

September 29, 2020 

12:00 pm ET 

Coordinator: Welcome and thank you all for standing by. At this time all participants will 

be in a listen-only mode until the question-and-answer portion of today’s 

conference. During the question-and-answer portion if you do have a question 

you may use Star 1. 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 Ivory Howard. Thank you. You may begin. 

Ivory Howard: Hello and welcome to today’s FDA Webinar. I’m Ivory Howard of CDHR’s 

Office of Communication and Education. Welcome to the ninth CDRH

Webinar in a Respirator Webinar series. The FDA along with the Centers for 

Disease Control and Prevention National Institute for Occupational Safety and 

Health, NIOSH and the Occupational Safety and Health Administration 

OSHA will be available to answer your questions related to respirators and 

other PPE for healthcare personnel use during the COVID-19 pandemic. 

Following a few opening remarks we will open the line for your questions 

related to information provided during today’s discussion. I now give you Dr. 
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Binita Ashar the Director of CDRH’s Office of Surgical and Infection Control 

Devices and the Office of Product Evaluation and Quality.

Dr. Binita Ashar: Great thank you and welcome everyone. As (Ivory) mentioned this is the ninth 

session in our biweekly Webinar series on Personal Protective Equipment or 

PPE. At our prior Webinars we have spent the first part of the session 

discussing policies and scientific considerations related to filtering face piece

respirators, facemasks, gowns and other apparel and then taking live question 

and answers for the remainder of the session.

The format of today’s Webinar is more of a town hall where the entire session 

will be devoted to answering your questions related to PPE. As (Ivory) 

already mentioned we have on the line with us FDA representatives and our 

federal partners and colleagues from CDC, NIOSH and OSHA. To get started 

I have some frequently asked questions that I would like to run through first 

before turning it over to the question and answer session.

So the first question is, “Can I reuse a cloth gown?” And the answer is yes 

cloth gowns that will not be used in a sterile field such as surgery can be 

reused if they are laundered in enzymatic detergent or per the hospital 

standard operating procedures. 

Okay second frequently asked question, “Are surgical masks required to be 

NIOSH certified?” No surgical masks are Class II medical devices subject to 

510(k) review. During the COVID-19 public health emergency surgical masks 

may also be marketed under the FDA enforcement policy guidance and/or the 

emergency use authorization for surgical masks. NIOSH certification is not 

applicable to surgical masks.
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Third question, “Can a surgical mask or a facemask claim conformance with 

NIOSH filtration efficiency standards?” No. Masks cannot make any claims to 

meet a NIOSH filtration efficiency standard. Such claims can only be made 

for a respirator when the respirator meets the specified filtration efficiency.

Next question, “What masks can be decontaminated and with which 

decontamination system?” The answer according to CDC’s recommendations 

decontaminated respirators should only be used when unused - with new FDA 

cleared N95 respirators, NIOSH approved N95 respirators or other FDA 

authorized respirators are not available.

The decontamination systems authorized for emergency use by FDA are only 

authorized to decontaminate non-cellulose compatible N95 respirators. As 

such healthcare personnel should not reuse a respirator that is incompatible 

with an authorized decontamination system but has nonetheless been 

decontaminated using such a system. Users of any respirator whether or not it 

has been decontaminated should always assess for proper fit after placement. 

Respirators with poor fit, visible soiling or damage should not be used. 

Additionally please check the scope session of the letter of authorization in the 

fact sheet for each individual decontamination system. If you are not sure 

please contact the manufacturer of the decontamination system. Note that for 

vaporized hydrogen peroxide based decontamination systems cellulose-based 

respirators cannot be decontaminated. Please note that FDA has not 

authorized any decontamination system for decontaminating surgical masks or 

facemasks.

And the last frequently asked question, “I would like to import masks for 

COVID-19 what do I need to do?” The answer to avoid delays of legitimate 

shipments we urge importers to review the importing supplies for COVID-19 
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and instructions to importers for important information about importing 

product including facemask and surgical masks to ensure the proper 

documentation is submitted at the time of entry. 

The FDA is ready and available to engage with importers to minimize 

disruptions during the importing process. If you have questions related to the 

general importation process you may email covid-19fdaimporting inquiries all 

one word at covid-19fdaimporting inquiries@fda.hhs.gov. If you have 

questions regarding an active entry please contact the FDA office covering 

your port of entry by visiting the FDA Import Offices and Port of Entry page. 

With that we are going to switch over to our live question and answers. 

Operator can we have our first question please? 

Coordinator: Thank you. We would now like to open the phone lines for any questions. If 

anyone does have a question please unmute your phone, hit Star 1 and record 

your name when prompted. Again that’s Star 1 to ask a question and Star 2 to 

withdraw your question. One moment while we wait for the first question.

And it looks like we have one queuing up, one moment. And our first question 

is from Mr. (Glenn Fey). Your line is open. 

(Glenn Fey): Yes this question relates to power air purifying respirators specifically for 

biological for COVID-19 issues? And basically we were - it’s very unclear 

does the EUA cover that or do we have to go through NIOSH and get that - go 

through the standard application procedure? And then the other question I 

have is if we do the standard application procedure how long would that take 

for testing?
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Dr. Binita Ashar: This is Binita Ashar. Thank you Mr. (Fey) for your question. I’m going to 

direct your question to Dr. Cynthia Chang and Afton Ross. Can one of you 

address it please?

Dr. Cynthia Chang: Hi. Yes this is Cynthia Chang. Thank you for the question. I can start. So 

we do have an EUA that allows for the use of NIOSH approved powered air 

purifying respirators which would be authorized under our EUA for use in 

healthcare settings. That is for NIOSH approved power air purifying 

respirators.

So if you have NIOSH approval then you are authorized under the FDA EUA. 

If you are not authorized then you should seek NIOSH approval 

(unintelligible) NIOSH. And I’ll...

Dr. Binita Ashar: And then... 

Dr. Cynthia Chang: Go ahead. 

(Jeff): Cynthia this is (Jeff)... 

Dr. Binita Ashar: Please (Jeff) go ahead. 

(Jeff): So I’ll go ahead and chime in. So, you know, as Cynthia said if you’re 

interested in NIOSH approval of a powered air purifying respirator that offers 

particulate protections in accordance with our regulation there’s several 

factors that play into the time considerations with approval of a device like 

that. So we do have a prioritization policy on our Web site. And you’ll note

that, you know, folks that do all of their manufacturing, quality assurance and 

design and development activities domestically certainly are getting priority.
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So I - the second thing I want to reinforce is that the NIOSH approval is much 

more than just a testing scheme. So we are also interested that you meet all the 

minimum quality assurance requirements within the standard. So that’s 

typically where the most - that’s typically the most challenging aspect of 

achieving approval. So certainly if you have additional questions after, you 

know, this Webinar you can reach out to myself and I can provide you some 

more details about the process.

(Glenn Fey): Okay thank you. 

Coordinator: Thank you. And again that is Star 1 if you have a question on the phone. And 

next we have (Maher Diudi). Your line is open. 

(Mayor Diudi): Yes hi. Can you hear me? Hello. 

Dr. Binita Ashar: Yes we can hear you. 

(Maher Diudi): All right great. So a question for you guys so the CDC and NIOSH had a new 

rulemaking of the PAPR of 100 on April but they’re still talking about using 

the HEPA filter NERVH17. Now the crew we are working with and we’ve got 

basically a PAPR system that is literally 3000 times better than what’s kind of 

out utilizing a more advanced filtration system. The problem is the NIOSH

rules basically are stated that you have to have an LPM range that you have to 

stay within but we need to be over 170 LPMs in order for this to work. But 

this is 99 like 99.99999% it captures COVID so that’s one.

And then two we’ve created an open source (unintelligible) self-oxygen 

concentrator anybody could build utilizing common parts around you 

including, you know, at Home Depot and online. There’s several people who 

kind of our building these. Proven it works great. It filled the oxygen gap. So 
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it is a DIY open source model we’d like to see how we can get, you know, 

more of this out there. This has been actually like - people from the World 

Health Organization and there’s some really big - we’ve got like 200 very 

strong readers chief medical directors backing this as well.

Our chief medical director is the chief residency director for Kaiser. And so

but everyone is like this is what’s needed right? So it’s - I guess we’ve got 

awesome products here we’d like to push through before the second wave 

obviously. But how do we – we need some help to navigate through the 

regulations to get these out. And of course adjust - I mean that one rule would 

you guys adjust that rule of the 170 LPM to allow it just allow an increase in 

LPM for the PAPR to work?

Dr. Binita Ashar: This is Binita Ashar. I think you have several questions embedded in there but 

perhaps I’ll turn it to my CDC colleague Dr. (D'Alessandro) to perhaps talk 

generally about the rule and common considerations related to filtration 

systems. And perhaps part of the question may need to be taken off-line to 

discuss your particular circumstances but let me turn it to Dr. (D'Alessandro). 

Dr. Maryann D’Alessandro: Binita, Jeff is going to take this one thanks. 

Dr. Binita Ashar: Okay wonderful. Thank you. 

(Jeff): So hi. I’m Jeff again. So, you know, essentially I think one of your concerns 

was, you know, the minimum airflow rate correct? 

(Maher Diudi): It’s actually the maximum airflow rate is at 170. It needs to be more than - we 

need more than that. 
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(Jeff): Actually a misinterpretation. So the minimum airflow rates for a tight fitting 

powered air purifying respirator are 115 and for a loose fitting system 170. So 

if you’re maximums are a bit higher that’s fine as long as you would continue 

to stay in the realm of not creating too much noise within the hood if the hood 

goes over the ears. That’s one of the concerns along with, you know, drying 

out eyes and such. 

So, you know, what I think I, you know, from based on what you said if 

you’re greater than 170 we should be good and we can take this discussion, 

you know, off-line to discuss specific details. In terms of, you know, the open 

sourcing question that’s not the way that a NIOSH approval is set up to work. 

So whoever the approval holder is owns the design, controls the design and 

controls the manufacturing. So in terms of open sourcing product that’s not 

possible to achieve under a NIOSH approval it would need to be controlled by 

the approval holder. 

(Maher Diudi): Okay. So how - when you’re saying take it off-line how can I get in touch 

with you and (unintelligible) and have a kind of designer engineers on there as 

well?

(Jeff): So I can certainly give you my email address. Binita is it better to do that in 

some other manner or can we say it out loud here? 

Dr. Binita Ashar: I think what we might have this individual do is make sure that the operator 

has your contact information and so that we can circle back with you. 

((Crosstalk))

(Maher Diudi): And if you want can I just give you the - my email address. It’s very simple 

Maher M-A-H-E-R@shieldmission.com. Does that help? 
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(Jeff): Sure thank you. 

Dr. Binita Ashar: Great thank you

(Maher Diudi): You’re welcome.

Dr. Binita Ashar: I think we’re ready for the next question. 

Coordinator: Thank you. And our next question is from (David). Your line is open. 

(David): Hi there. Thanks for making the time this afternoon. I had a quick question to 

confirm whether the reusable quarter face piece elastomeric respirators would 

be considered to be within the product code MSH and if not which would be 

appropriate product code for the thinner product. 

Dr. Binita Ashar: I think I’m going to first turn to my FDA colleagues to see if somebody from 

OHD4 knows the answer to that question. Dr. Chang, would you know the 

product code? 

Dr. Cynthia Chang: Hi. This is Cynthia Chang. Maybe I can try to address the question. So for 

elastomeric respirators they do not fall under MSH. That is for filtering face

piece respirators such as N95s that are surgical respirators. At this time there 

is not a specific product code for elastomeric respirators however they are 

covered by the umbrella EUA for NIOSH approved air purifying respirators.

So if you have an elastomeric respirator that is approved by NIOSH then your 

elastomeric respirator would be covered or it would be authorized for use by 

healthcare personnel for the duration of the public health emergency. 
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(David): Perfect. And then a quick follow-up, what would be the most prudent thing to 

pursue in preparation for the emergency period being lifted provided we 

would have NIOSH approval? 

Dr. Cynthia Chang: Yes I would recommend that you contact our Office of Surgical and 

Infection Control Devices for specifics about the marketing of their specific 

device.

(David): Perfect. Thank you. 

Coordinator: Thank you. Our next question is from (Jose Chavez). Your line is open. Mr. 

(Chavez) your line is open. 

(Jose Chavez): Hello. Good morning.

Dr. Binita Ashar: Good morning.

(Jose Chavez): Good morning everybody. I was overhearing the conversation regarding 

prioritizing domestic firms specifically for the, you know, the appropriate 

approval processes for pursuing NIOSH approval for face piece respirators. 

I’m unsure whether that same type of policy is being applied for the nonNIOSH approved respirators under the EUA Appendix 1. I have been noticing 

a tremendous influx of approvals for respirators that are specifically from one 

jurisdiction. In fact there was one jurisdiction a whole standard created for one 

jurisdiction.

Now for the KN95 type of respirators but for the Appendix 1 which is the - 

which was release I believe or updated in June 6 of 2020 that lifted EUAs or 

our approvals have not really changed. Actually as of August 21 there has not 

been any recent updates to any approved manufacturers or establishments that 
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have submitted products for review under that EUA. And I’m starting the 

question - the prioritization here because for example our firm submitted an 

EUA under Appendix 1 for respirators back in August 10 and it’s now 

September 29 and we have not gotten a response that would quantify either an 

approval or a rejection.

Dr. Binita Ashar: Hi. This is Binita Ashar. I can start and then I might turn it over to my 

colleague at FDA Dr. Ross to chime in. So, you know, it’s very difficult to be 

able to tell a particular - any company the exact duration of time it’s going to 

take to review an EUA application simply because companies may have a 

different amount of preparedness if you will with their application. So they’re, 

you know, sometimes applications are set and ready to go all of the 

information is present and it’s a matter of processing in other cases the teams 

and several individuals are involved in the review and there’s a lot of back and 

forth discussion. I think as we said at prior Webinars we are however very 

committed to making sure that we have good communication with the 

applicant so that you know the status of your file. 

Now with respect to prioritization specifically for non-NIOSH approved 

respirators I’m not aware of any particular prioritization related to domestic 

versus outside of the US but I’ll have Dr. Ross may be comment on that. 

Afton Ross: Thank you Dr. Ashar. So just to make sure that everyone is clear. I think the 

caller might understand this but I think that the way it might have been posed

might be a little confusing for others. So I just want to make sure that 

everyone understands that the EUA that’s being referenced is for imported 

respirators. So these are from countries other than China. So we’re not talking 

about domestic manufacturers here. I just want to make sure that that point is 

clear.
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And certainly as Dr. Ashar said we have staff that are working on these 

submissions. We are getting a good number of submissions and it takes time 

to work through those. We will try to be as communicative as we can. And 

certainly if we have questions or need additional information as we review 

your submission we will reach out with regard to that. But certainly, you 

know, we are recognizing the importance of these products but as Dr. Ashar 

said it does take some time and we are receiving a good volume of 

submissions. 

(Jose Chavez): If I may ask, you know, we – despite the fact that the full - the manufacturer it 

is foreign us our company is here in California is the design holder. And we 

have begun communication was Dr. Attwood to pursue the appropriate CDC 

NIOSH approval which encompasses the quality management system as well 

as the product approvals. But just it’s a little bit - we haven’t had - we haven’t 

received a straight answer yet from anybody from the FDA on this.

(Jeff): Okay. 

(Jose Chavez): And we followed the - we followed the guidance document that was provided 

and updated on August 21 verbatim. And so that’s why I’m - it’s a little bit 

disheartening and trying to understand what is it that we’re, you know, we did 

not provide that is postponing aside from understanding the workload that 

both, you know, the Center for Disease Control and the Food and Drug 

Administration are undertaken during this pandemic. So I – it’s a degree of 

communication yes. But it’s also in reference to I have not – have made it as 

straightforward as possible so that reeling our package would be user-friendly 

for lack of a better word. 

Dr. Binita Ashar: Right so this is Binita Ashar. I think we’re talking about two different things 

there. So I just want to make sure that we’re very clear so the authorization 
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process involving these respirators that is something that you would come to 

FDA for. Now what it sounds like is it sounds like you’re looking for actual 

approval of your respirator. And that would be a CDC led effort. And so I will 

turn to my CDC colleagues and see if they have any additional advice or 

feedback regarding the approval process?

(Jeff): So this is (Jeff). So Mr. (Chavez), you know, we can - if you could contact me 

off-line that would be great. We can talk about the details. You know, 

certainly I think we are providing every effort to correspond with everybody 

who makes a request and share with where they may be deficient in their 

request. For what it sounds like you’re trying to achieve is approval of some 

type of respirator and you’re trying to get your manufacturing code in order to 

pursue that. 

So, you know, there is a process for that. The questionnaires need to be 

completely, you know, filled out. And typically what happens if there is a 

deficiency identified that is communicated. So, you know, if, you know, there 

again I think this is a better conversation to have off-line to talk about the 

details but certainly we can see where you’re at if you contact me and try to 

provide some clear guidance if that’s the case the needs to happen.

(Jose Chavez): My apologies I think I may have misplaced my question. I guess I didn’t 

explain myself properly. We’ve submitted a request to be added to Exhibit 1 

of the authorizing import non-NIOSH disposable face respirators. And that 

was updated on August 21. So we have a very short list of companies that are 

on that list so establishments excuse me manufacturers.

We are in parallel coordinating or actually we already initiated the 

questionnaire process with Dr. Attwood. So my - and we understand the 

priority of those domestic versus nondomestic manufacturers, establishments 
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design holders of face piece respirators especially in this context N95s. My 

concern -- and what’s probably coming out as a little bit of frustration -- is the 

really the lack of appropriate response or review on the FDA side on 

reviewing our applications within the confines of the FDA not the CDC.

Dr. Binita Ashar: Okay well I think what I would encourage you to do is to circle back with 

your point of contact at FDA because like I said before we are committed to 

letting you know what the status is of your application. You know, I know 

that, you know, it is frustrating. We have a lot of work that we’re trying to 

plow through and, you know, it’s never as fast as we all wanted to be. But our 

staff are working around the clock and are committed to their jobs and to 

being responsive. So I think I would, you know, do whatever necessary to 

communicate to the team the urgency around your request and solicit any 

feedback from them regarding what might be necessary to move your 

application forward. 

(Jose Chavez): I appreciate that. Thank you.

Coordinator: Thank you. Next we have (Michelle Lott). Your line is open. 

(Michelle Lott): Hi. I have been working on several different types of submissions between 

EUAs and actual 510(k) submission. And I’m getting a wide variety of 

feedback about the ASTM 2119. And the FDA’s interpretation of the AQL

sample size as well as the interpretation of three nonconsecutive lots. And I’ve 

worked in masks a long time before health crisis and this is the first time that 

we’re getting feedback like this. I know that ASTM is subject to be rewritten 

October 20 but can the FDA speak to these changing requirements that might 

be happening behind the scenes right now internally and then how you’re 

going to consistently implement them, you know, moving forward? 
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Dr. Binita Ashar: Thank you for that question. This is Binita Ashar. I’m going to turn it to my 

colleagues in OHT4. Dr. Jiping Chen, can you comment on this? 

Dr. Jiping Chen: Yes sure. This is Jiping Chen. Thank you for the question. So your question is 

about our, you know, the sampling size and the large media to demonstrate the 

performance of the surgical mask.

So this request is consistent to the way ASTM (unintelligible). For the broader 

penetration testing we request three - two samples per lot for the testing which 

is based on the ASTM (unintelligible) which would extend the referenced in 

the (unintelligible) 100 applicant is also FDA recognized standard. So the 

sample size - so there’s two samples per lot for the test.

Then for the left the performance testing including the particulate 

(unintelligible) testing and the bacteria filtration testing (unintelligible) testing 

et cetera. And based on the ASTM (unintelligible) 2019 version. And for each 

of the performance testing and you need to (unintelligible) 4% based on the 

then the sample size should be selected based on the product and lot size and 

(unintelligible). 

And then ASTM can be 100 also reference the site here two standard for the 

examples of acceptable sampling plan is this to standards size here in the 

ASTM 100 are also FDA recognized. So what we request is based on the FDA 

recognized standards on the ASTM 100. 

And also when we do the 510(k) review we will also consider the - your 

claim. For example if your claim ASTM can be one Level I. And if you can 

claim the conformance standards to expect here all the testing should be 

conducted in accordance to the standard new (unintelligible) new claim 

conformance. So this is – and look regarding the lot size, you know, it is our 
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general recommendation you need to demonstrate a loss to market perform to 

demonstrate your mask can perform as intended consistently across the 

different production lots. 

So this is the basis the scientific basis and the regulatory basis for our request. 

We people are asking if we are raising the acceptance bar for the surgical 

masks under review we are not and all the requests in consistent with the 

industry consensus standards and also consistent with our regulatory history 

too. Our regulatory history is based on, you know, the (unintelligible) identify 

and also and the claim you try to made. And to demonstrate your device is 

safe and effective and the performance well or better than the private device 

identified.

Woman: Thank you for that. And just to bring it to the agency’s attention I know that 

it’s always desirable to be able to count for lot variation between test methods 

or test sample sizes. However particularly for masks most of this raw material 

comes off of rolls and a single shipment of raw materials might not capture 

the lot variation that the agency may be anticipating and would be a 

significant investment for industry to give the quantity of raw materials to 

capture this type of variation. 

Dr. Jiping Chen: And this is Jiping Chen again. Thank you for your comment. But just for FYI 

our 510(k) (unintelligible) for the substantial equivalents is based on the final 

finished device. So our review is not based on the raw materials will use 

and/or each of the raw materials you use.

So all the performance testing should be based on the final finished device 

because the final finished device after going through all the manufacturing

processes including sterilization if we’re (unintelligible) and the main change 

here the (unintelligible) of the raw materials. So all the performance testing is 
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expected to be conducted based on the final finish of device - product you 

intended to put on the market. 

Dr. Binita Ashar: This is Binita Ashar. I just wanted to, you know, thank you for the feedback 

regarding the, you know, the testing may appear burdensome. But I do want to 

point out just one thing is that we have several we - during the pandemic now 

we have developed several pathways by which these important devices are 

able to be marketed.

If you want to look at it this way the lowest bar would be adherence to our 

enforcement policies. So those exist for surgical masks. And then there is the 

umbrella EUA for surgical masks. And those requirements are a little bit more 

than what is required in the enforcement policy. 

And then finally is there the 510(k) requirements which allow your masks to 

be marketed beyond the public health emergency. And the 510(k) 

requirements have been the same requirements that we had even before the 

pandemic. So I think that, you know, you’re doing the right thing. You’re 

already marketing your device either under our enforcement policy or under 

the EUA and you’re moving to meet the requirements of the 510(k). 

But these have been very standard requests for our 510(k) review practices. 

And while we encourage manufacturers to submit 510(k)s we are not 

changing our requirements for the purposes of the pandemic because we 

already have done so with respect to the enforcement policy and the umbrella 

EUA. But we do appreciate your feedback and thank you for the question. 

(Michelle Lott): Thank you. You bet. 

Coordinator: Thank you. Next question comes from (Russ Olmsted). Your line is open. 
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(Russ Olmsted): Yes good afternoon everybody. Thanks for providing this forum and really 

appreciate the convergence of OSHA, NIOSH, CDC and FDA on this. I think 

it’s very helpful. I have two questions. The first one is have the agencies 

looked at or worked with professional organizations around other types of 

respiratory protection in the surgery suite specifically PAPRs or elastomeric

respirators in those settings? I know there’s theoretical concern about 

contamination of the surgical site when those are worn but I - there is some 

preliminary evidence that that probably is not a major issue certainly for 

people that are not directly involved in the procedure like the surgeon and first 

assist but just curious on that one. 

Dr. Binita Ashar: I think it’s a great question. Thank you for asking it. I’m going to turn to my 

OSHA and CDC colleagues to see if they wanted to address that question? 

Andy Levinson: So this is Andy Levinson from OSHA. And from OSHA’s perspective our 

authority and jurisdiction is only for the workers in the surgical suite. And 

from a worker safety and health perspective there’s no concern. I think the 

infection control issues you’re raising are more going to wind up being FDA 

and/or NIOSH issues.

(Russ Olmsted): Great. 

Dr. Maryann D’Alessandro: This is Maryann from NIOSH. We do have some preliminary data 

that is saying that it is not an issue to use these devices in the surgical suite. 

But currently the CDC guidance is that if you are using them you’re using 

elastomeric respirator you should have a surgical mask over the respirator a 

surgical mask with ties so it does not compromise fit. And if you’re using a 

PAPR then you should have one underneath the PAPR. 
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So again we do have some preliminary data. We do believe in the future they 

guidance will be updated but at this point in time those of the CDC 

recommendations. Thank you. 

(Russ Olmsted): Great very helpful. That sounds good. And then part two is - we from our 

supply chain leaders within our health system have - are aware of some 

pending or concerns about a shortage of raw materials related to the 

development or production of gowns and other materials such as - that involve 

spunbonds for example. Are FDA and CDC kind of revisiting their 

contingency in crisis strategies if we do end up with for example on the 

surgical site or surgical suite where we may not have foot covers or gowns 

available, you know, traditional materials but just curious if there’s any 

awareness or discussion on those?

Dr. Binita Ashar: This is Binita Ashar from FDA. I think, you know, our CDRH team is always 

monitoring and, you know, for potential shortage issues. Now whether or not 

they’re familiar with this one this specific item I am uncertain. I don’t know if 

Dr. Ross you have anything to add around this potential shortage issue? 

Afton Ross: Thanks Dr. Ashar. So as Dr. Ashar said we continue to engage with various 

public health stakeholders to understand where there might be supply chain or 

product availability concerns as well as what might be some of the root causes 

of that. Very early on in the pandemic FDA had communicated about 

alternatives for consideration when you have short supply of various types of 

PPE certainly linking to CDC guidance as appropriate for regard to that.

We continually look at that information to see whether it makes sense based 

on new information that may come in to make any updates. So we haven’t at 

this time but certainly please know that we are monitoring the situation that 

we can evaluate the mitigations that have been put forward to see whether 
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Page 20 

there might be other options depending on where we are in the pandemic 

scenario.

(Russ Olmsted): Great very helpful. Appreciate it. Thanks so much. 

Coordinator: Thank you. Our next question is from (Ricardo Romero). Your line is open. 

(Ricardo Romero): Well good afternoon. So my question is (unintelligible) the 510(k) while 

we know right now in the pandemic and the universe for these the 510(k) but 

we’re actually searching through the forest fires in this process to export from 

our manufacturing company per the US. And we would like to know how 

much time do you think it actually takes? We’ve been told around from six to, 

six months to eight months but we want to hear it from. 

Dr. Binita Ashar: And thank you. I think your question was is how long is the review time for a 

510(k) submission on a Personal Protective Equipment device. Maybe I’ll 

have Dr. Chang would you like to address that question? 

Dr. Cynthia Chang: Yes hi. This is Cynthia Chang. So for 510(k) the – during the public health 

emergency we were recognizing the importance of prioritizing these

submissions. And so we are doing that. We are, you know, putting a high 

priority on PPE 510(k)s.

The typical review time for a 510(k) is 90 days for FDA’s review. If there is 

the need for additional information to be requested or any additional testing 

then we might place the file on hold to stop our 90 day review clock to allow 

the company to, you know, get that additional information and respond back. 

So at this time as I mentioned we are actually prioritizing PPE submissions. 
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The, you know, the time that it takes for a particular submission really 

depends on the completeness of the submission when it comes in. So if you, 

you know, have most of the testing done and most of the information or all of 

the information and all of the testing available at the time of submission then 

the review process is going much faster than the typical 90 day review clock. 

However, you know, if it’s not complete then it might actually take longer as, 

you know, we have to work with the companies to bring them, you know, to 

the point it may be cleared. We are working interactively with (unintelligible)

to get them across the finish line as much as possible because we do recognize 

the intensive need for these PPE devices. Thank you. 

(Ricardo Romero): Thank you. 

Coordinator: Next we have – go ahead. 

(Ricardo Romero): Yes (unintelligible) thankyou much. So I was wondering if you already 

got all that you need for our submissions speaking ASTM testing and all the 

paperwork. I just want to know like the approximate time to the really didn’t 

hear it’s (unintelligible)... 

Dr. Binita Ashar: Okay this is Binita Ashar. I think what you’re asking is the specific status of 

your file related to some of the testing that you’ve provided. So what I would 

do is I would reach out to the lead reviewer that’s been assigned to your file 

and ask them if they have all the information that they need. As Dr. Chang 

pointed out we are looking to be interactive with the submitter so that if there 

is a question that we will pick up the phone, give you a call, ask you to 

provide the information on the order of days so that we can continue to move 

forward and progress the application.
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(Ricardo Romero): All right that sounds perfect. Thank you. 

Dr. Binita Ashar: Thank you. 

Coordinator: Thank you. Next we have (Janel Bentz). Your line is now open. 

(Janel Bentz): Hi. Thank you. My question is related to the sampling plan question. ASTM 

F2100 references 16 CFR Part 1610 for the flammability testing. That 

standard very specifically talks about how many samples to test for the 

testing. And it’s up to 14 but it usually ends up being nine. With the request 

for 32 samples from the FDA is there a proposal from them about how to 

modify the standard to accommodate that? 

Dr. Binita Ashar: This is Binita Ashar. I’m going to ask my colleague Captain (Claberle) if she 

could answer this. I know that she’s aware of some of the work that’s being 

done by the standards organization. 

(Claberle): Hi. Thank you so much for the question. And I’m going to just so I can make 

certain that I respond to you correctly would you please remind repeating the 

question for me please?

(Janel Bentz): I would love to. With the questions about sampling size ASTM F2100 

references 16 CFR Part 1610 for flammability testing. That CFR speak 

specifically to the number of samples to be tested. Usually ends up being for 

four preliminary testing and then five samples and there’s potential for there 

to be five more for a total of 14. But just wondering if the FDA has a 

recommendation for accommodating either, you know, going back to that 

requirement for the CFR without that AQL or modifying that CFR to allow 

for AQL testing?
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Page 23 

(Claberle): Okay very, very good question. So right now we are actually working with the 

standards organization. We are looking at the standard of to see whether or not 

– we’re looking at the standard right now because as you know ASTM is 

thinking about making some changes to the standard. And we hope to be able 

to come out with better guidance in the very near future but as of right now 

we’re continuing to follow the standard that’s current. And I’m going to ask 

Dr. Chen if she has any more visibility on anything in addition to what I said 

from the standards organization? 

Afton Ross: Sorry if I could just clarify before Dr. Chen there are two standards here 

F2100 talks about an AQL of 4% but the CFR that’s referenced gives a 

specific number to test. So it’s confusing to know which standard to follow 

when the testing standard gives a number to test but we’re being asked to test 

a different number.

(Claberle): Dr. Chen... 

Dr. Jiping Chen: Yes thank you for the question. So actually this is related to the question. This 

is something of the standard that show that, you know, will make more 

collaboration in the next division. So regarding the flammability testing the 

standard efficacy 100 the referenced for the CFR 1610 for the standard 

method. So yes for the standard method (unintelligible) we also agree and 

they should follow the method of the 16 - CFR 1610. 

But the CFR 1610 standard itself is not recognized by the FDA yet. So 

regarding the sampling plan the efficacy 100 says it’s 4% says the sampling 

size should be collected based on the production lot size and also the standard 

(unintelligible) in the two standard (unintelligible) in the efficacy 100 for the 

sampling plan. 
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Page 24 

So my recommendation is if you believe your sample size is adequate then 

you provide certification during the 510(k) to follow 510(k) submission. But 

right now and we, you know, think that the ASTM efficacy 100 is your - the 

ASTM is the most current and we should be recognized and generally we will 

go with the efficacy 100 until it is realized and recognized by the FDA. 

But always while the standard if you reference the ASTM efficacy 100 and 

claim the performance to the standard (unintelligible) if you do the testing 

based on your conformance to the standard. I mean always you can provide 

the originals for any (unintelligible) made from the standard we will review 

your scientific (unintelligible) and also the (unintelligible) to see if it’s 

acceptable.

(Janel Bentz): Thank you. 

((Crosstalk))

Dr. Binita Ashar: Hi. Binita Ashar I just wanted to with that last question wrap up from my end 

and then turn it over to (Ivory). We, you know, again want to thank all of the 

subject matter experts who joined us today. Our next session will take place in 

two weeks on Tuesday, October 13 at noon Eastern. 

The announcement of topics will be forthcoming. And we encourage you to 

share with us those that might be of interest to you. I’d like to know turn the 

session over back to (Ivory) who will close it out.

Ivory Howard: All right thank you. This is Ivory Howard. We appreciate your participation 

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

on the CDRH Learn Web site at www.fda.gov/training/cdrhlearn by 

Wednesday, October 7. If you have additional questions about today’s 
FDA Webinar 

Moderator: Ivory Howard

09-29-20/12:00 pm ET 

Page 25 

presentation please use the contact information provided on the slide. As 

always we appreciate your feedback.

Following the conclusion of this Webinar please complete a short survey 

about your Webinar experience. The survey can be found on 

www.fda.gov.cdrhwebinar immediately following the conclusion of this 

Webinar. Again thank you for participating. This concludes today’s Webinar. 

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line and enjoy the rest of your day. 

END