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Moderator: Irene Aihie

06-09-20/12:00 pm ET

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FDA Webinar Series:

Respirators for Health Care Personnel Use during COVID-19 Pandemic

Moderator: Irene Aihie

June 9, 2020

12:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participant lines are 

in a listen-only mode. The question-and-answer portion will follow today's 

presentation. And at that time, you may press Star then 1 on your phone's 

keypad to ask a question during today's conference call. Today's conference is 

being recorded. If you have any objections to this, you may disconnect at this 

time. And now I would like to turn the call over to your host for today, Ms. 

Irene Aihie. Ms. Aihie, you may begin.

Irene Aihie: Thank you. Hello and welcome to today's FDA webinar. I am Irene Aihie, of 

CDRH's Office of Communication and Education.

Today's discussion will focus on the topic of respirators for healthcare 

personnel's use during the COVID-19 pandemic. Today, Dr. Jeff Shuren, 

Director of the Center for Devices and Radiological Health here in the CDRH 

at the FDA will be joined by FDA Commissioner Hahn and members of 

CDRH. We are also joined by our colleagues from OSHA and NIOSH.

Together we will share information and answer questions about emergency 

use authorizations and decontamination of respirators and the overall actions 
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that have been taken to help ensure healthcare personnel on the frontlines have 

the necessary supplies of respirators to meet the demand.

Following the presentation, we will open the lines for your questions related 

to the information provided during today's presentation. Now, I give you Dr. 

Shuren.

Dr. Jeffrey Shuren: Thank you and hello everyone. I'd like to welcome you to the first in a series 

of biweekly webinars on personal protective equipment. Our goal is to provide 

you with information and with the latest updates as well as to address your 

questions.

Today's inaugural session is focused on respirators, our authorizations, our 

policies, the changes we've made and why. Just as the clinical community in 

caring for patients with COVID-19 has been learning on the job and adapting 

as new information becomes available, we too are learning as we go, 

modifying our approach as new information and changes on the ground 

warrant. None of us has the luxury of time. We have to do the best we can 

with what we know and what we have available, recognizing that 

circumstances will change, and we will adapt with them.

To begin our dialogue with you, it is my pleasure to introduce the FDA 

Commissioner, Dr. Stephen Hahn. I'll turn the microphone over to him now.

Dr. Stephen Hahn:Yes, thank you, Jeff, very much and also for the opportunity to be with all of 

you today and help welcome everyone to this first of a series of FDA webinars 

today on respirators for healthcare use during the COVID-19 pandemic 

response.

I also want to thank our federal partners, CDC, NIOSH, and OSHA for their 
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collaboration and for joining this important dialogue. As we are all well 

aware, it has been an extraordinarily challenging time for the nation and the 

world. And a crisis of such unprecedented magnitude requires all of us joining 

together to work.

Our partnership with NIOSH and OSHA is a good example of how we work 

together towards a common goal in this assuring that our healthcare workers 

have the necessary personal protection that they need to serve on the frontlines 

of care. And my many thanks to those frontline healthcare workers who have 

just done an extraordinary job during this difficult time.

And I want to thank everybody else on the line today who's with us for your 

commitment and hard work during the pandemic. A special thank you to the 

manufacturers who are on this call, whether a traditional device manufacturer 

or one who is new to healthcare. Your continued efforts to increase the supply 

of respirators for healthcare workers and serve the American public during the 

pandemic are greatly appreciated.

And finally, I want to give a shout out to the FDA staff and the agency's 

exemplary leadership team, our center directors, and our other commissioner 

groups. They have been just extraordinary during this time. I'd barely begun 

my work as FDA's Commissioner when the COVID-19 virus appeared and 

really changed our world.

And having had the opportunity to watch, work with, and rely on the FDA's 

staff during this public health emergency has just been an extraordinary 

experience. And I hope this is a once in a lifetime experience, of course. But it 

has been just remarkable to see the FDA team at work and how the 

collaboration has been with all of you on the phone. I can say that both I, 

personally, but also the American people are in great hands with the FDA.
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We continue to be involved on many different fronts to ensure that we keep 

pace with the ever-changing landscape. And Dr. Shuren made a really 

important point which is that this will continue to change as we learn more 

and more about the pandemic. And our commitment, Dr. Shuren's 

commitment, and CDRH's commitment is that we will use all data available to 

us at the time it's available to reassess what we've done and to be flexible 

moving forward.

Special kudos to Dr. Shuren at the FDA Center for Devices and Radiologic 

Health. We've seen just how essential medical devices are to countering this 

pandemic. And CDRH has been at the forefront of our efforts to ensure that 

health professionals and others have the appropriate access to personal 

protective equipment. A major shout out to the 24-7 work that they have done.

The webinar series that we've launched today is another example of our 

continuing commitment to protect and promote the public health of all 

Americans. It underscores our focus on providing the public with the best 

possible information about the disease and have transparency in what we are 

learning about it and what we are doing to treat and prevent it.

We promise that we will continue with this level of transparency and today is 

just the start of these dialogues that we'd like to continue. One of my most 

important and fundamental professional beliefs in medicine has been the 

importance of promoting integrity and transparency in the scientific process. 

And that is an essential aspect of our work at FDA.

But to do this in the most effective way it requires a dialogue. And that's why 

it's critical that we hear from and engage with you today. And we will 

continue to do that, as I mentioned, moving forward. We want and we need to 
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know what you're observing, learn from the challenges you are facing, and 

how you're dealing with them.

This information will inform us and enhance our ability to serve the American 

people in the most useful way possible during these times of immense need. 

Our experience during COVID-19 has made clear that successful response is 

dependent in part on having respirators for which there has been such high, 

unprecedented demand to have it available for healthcare workers.

And since the early days of the crisis we have worked hard to ensure that there 

is adequate supply of N95 respirators, engaging with many different 

organizations and agencies in both the public and private spheres. We will 

continue to do our best to communicate our policies and to be transparent. 

And today is really the first step in engaging in this bilateral dialogue with 

large groups such as today.

I hope this webinar series supports that effort. And provides you and the 

public as a whole with increased understanding and clarity about FDA's 

ongoing efforts and our strong partnerships with NIOSH and OSHA as well as 

the opportunity to provide us with your feedback. We very much value the 

bilateral dialogue and exchange of information.

And we look forward to continuing our work together to ensure access to 

high-quality respirators for healthcare workers and other personal protective 

equipment. I want to thank you for allowing me to take a bit of your time. And 

now I'd like to turn it over to Bill Maisel. Thank you very much.

Bill Maisel: Thank you Dr. Hahn and Dr. Shuren. We very much appreciate your 

comments and your leadership during the COVID-19 pandemic. My name is 

Bill Maisel. I'm Chief Medical Officer and Director of the Office of Product 
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Evaluation and Quality at FDA’s Center for Devices and Radiological Health.

We're glad that you're able to join us for today's webinar on respirators for 

healthcare personnel use during the COVID-19 pandemic. And what we hope 

to cover today is again, a quick overview of the webinar series objectives. 

We'll provide introductions both to some of the people and the organizations 

that are participating.

We'll cover the terminology and provide an overview of facemasks and 

respirators just briefly so that we're speaking the same language. We will 

provide an update on FDA emergency use authorizations for respirators, our 

strategies for optimizing the supply of N95 respirators, and policies and 

authorizations for respirator decontamination and bioburden reduction.

That's a big agenda. But we will also save some time for questions and 

answers to make sure that we're able to address some of your questions. Next 

slide please.

We've already covered some of the webinar series objectives. But I think it's 

important for us to recognize that there can be an overwhelming amount of 

information - at times confusing and rapidly changing - concerning the safe 

and effective use of respirators for healthcare personnel.

It's our hope that this webinar series will help provide you with the 

information you need and answer questions you may have about respirator 

use. Because of the volume of information, it's not possible to cover every 

respirator topic in-depth during a single webinar. And we intend to conduct a 

series of webinars so that we may continue to provide updates on important 

actions impacting the needs and availability of respirators. And take deeper 

dives and more time on topics that are of interest to you.
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After today's event, the next webinar in the series is scheduled for two weeks 

from today, June 23 from 12:00 pm to 1 pm Eastern time. The bottom line is 

we all want to be able to provide support to make sure our nation's healthcare 

personnel and first responders have the information they need and the supplies 

they need to meet their demands. Next slide please.

FDA, CDC’s National Institute of Occupational Safety and Health or NIOSH 

and the Occupational Safety and Health Administration or OSHA collaborate 

to assure the safe use of respirators. We are very grateful for the close 

working relationship and collaboration with our sister organizations.

We're on the phone with each other quite literally daily and sometimes 

multiple times per day. We provide complementary perspectives and 

oversight. And have been working together very closely both before and 

during the pandemic.

We're very fortunate to have the leadership and scientific experts from each of 

the organizations present on the webinar today. And they'll be available to 

answer questions during the question and answer period at the end.

Clearly, the other important piece of background information is that the 

COVID-19 pandemic has created significant challenges to the availability of 

personal protective equipment including respirators. And each of our 

organizations has taken steps to address the shortages.

And today we'll be talking about FDA's emergency use authorizations of 

certain respirators and decontamination systems. FDA has also issued 

guidance on enforcement policies that together provide substantial regulatory 

flexibility to help facilitate access to critical, quality medical supplies. Next 
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slide please.

We'd like to take a few minutes to let you know who is on the webinar today 

from each of our organizations. And as I mentioned previously will be 

available later in the webinar to address questions. I'll also ask one person 

from each organization to take a couple of minutes to provide a brief overview 

of their organization's responsibilities.

I already mentioned I'm Bill Maisel from FDA. And we're joined today by 

Elizabeth Claverie, Assistant Director of the Personal Protective Equipment 

Reprocessing and Disinfection Devices team in CDRH as well as John 

Verbeten, Acting Deputy Director, Office of Enforcement and Import 

Operations in the Office of Regulatory Affairs.

We're also joined by Dr. Suzanne Schwartz who's Acting Director of the 

Office of Strategic Partnerships and Technology Innovation. And I'd like to 

ask Dr. Schwartz to provide a brief overview of FDA's responsibilities.

Dr. Suzanne Schwartz: Thanks so much, Bill. It's a pleasure to participate in this webinar. So 

again, I serve as the Acting Director of CRH's Office of Strategic Partnerships 

and Technology Innovation here at FDA. And FDA's oversight of respirators 

for use in healthcare spans the total product lifecycle from premarket review, 

postmarket surveillance, and compliance.

And during this COVID-19 pandemic response, FDA has employed tools that 

allow us to be far more agile in responding to a public health emergency of 

this scale so that we can be fluid when new information comes to light that 

warrants taking different approaches. In today's presentation, you will hear 

about some of the actions we have taken and our overarching effort.
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To meet the needs of the public health, we engage in broad outreach with 

many stakeholders that span the entire supply chain from manufacturers, to 

importers, distributors, group purchasing organizations, healthcare 

associations, professional and clinical societies, healthcare providers, patients, 

and our caregivers. Our work includes a broad array of cost-cutting efforts 

which includes close collaboration with our government partners, CDC, 

NIOSH, and OSHA.

We are delighted to have them participate in this webinar with us. And it's 

now my pleasure to turn to our agency partners starting with NIOSH. John 

Howard, can you please introduce yourself and your organization.

Dr. John Howard: Thank you Suzanne. NIOSH CDC is pleased to participate 

in this town hall with our colleagues from OSHA and FDA. As everyone 

knows, respirator use in American workplaces must be evaluated and 

approved for use by staff at NIOSH's national personnel protective technology 

laboratories under the direction of Dr. Maryann D'Alessandro who will be 

answering your questions today.

Some of NIOSH's COVID-19 respirator related activities include One, 

addressing over 3000 PPE related inquiries. Two, tripling the rate of respirator 

approval and denial decisions from 30 to over 100 decisions per month. Three, 

collaborating with the FDA which has developed several emergency use 

authorizations to significantly expand the inventory of respirators available for 

use in healthcare settings.

Four, promulgating an Interim Final Rule that created a new PAPR class to 

enable the approval of PAPRs more conducive to healthcare environments. 

Five, evaluating over 130 international respirator models in the past two 

months, finding that more than 50% of the models tested were substandard, 
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providing data needed to support the FDA's EUA decisions.

Six, publishing available research about respirator decontamination 

procedures. And seven, working with the Non-profit Center for Medical 

Interoperability to enhance an effort initiated in 2011 to develop the 

information technology architecture necessary to enable PPE data to transition 

from government-owned and secured system to one where hospitals are 

willing to share and exchange their respirator supply and utilization data.

Thank you again for the opportunity to highlight some of NIOSH's COVID-19 

activities in respiratory protection.

Bill Maisel: Thanks Dr. Howard. And now I'd like to turn it over to Amanda Edens on 

behalf of OSHA.

Amanda Edens: Thank you. This is Amanda Edens, I'm the Deputy Assistant Secretary for 

OSHA. And I'd like to start off by joining Dr. Hahn's thank you for all the 

workers on the frontlines that are working through this pandemic. Their work 

is really heroic and much appreciated.

Also, I'd like to thank FDA for the invitation to participate in this series. And 

also, we truly appreciate the collaboration we've had with NIOSH and FDA. 

And I think as mentioned earlier, sometimes we're on the phone multiple 

times a day trying to sort out the science as it becomes available.

Where OSHA sits in this area, as many of you probably know, we have set 

and enforce respiratory protection standards that regulate the selection, use, 

and maintenance of respirators in the workplace. However, OSHA also 

provides compliance assistance with various types of webpages and tools to 

help employers and employees understand how respirators work, how they're 
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to be put on and taken off and all that comes with that.

And in particular for COVID-19, we have issued guidance to help these 

employers and employees understand the types of respirators and other types 

of PPE that might be needed and are appropriate in certain types of workplace 

exposure to COVID-19 and how the OSHA standards would apply in those 

situations.

And we have also been working closely with FDA and NIOSH to help address 

some of the shortages in filtering face piece respirators that we've seen in 

healthcare. And in that respect, OSHA as issued a number of enforcement 

guidance memoranda to our compliance staff in the field on ways that OSHA 

can use our enforcement discretion, when appropriate, to address some of 

these shortages in the filtering face piece N95s.

We've issued a few of those and I can take questions on those. But I think as 

we have heard there is new science coming available. We'll continue to work 

with our colleagues at FDA and NIOSH to look at the changes in the 

pandemic and adjust our enforcement posture or our guidance as necessary. 

And I'll turn it back over.

Dr. Bill Maisel: Great, thanks for those comments and again, just thank you for the very 

collaborative spirit and nature of the cooperation between the agencies. Next 

slide please.

Before we get too far into the webinar series, we wanted to make sure that we 

were using the same terminology. We know we're joined by many different 

stakeholders today with different backgrounds, different knowledge bases 

pertaining to respirators. And we wanted to take a couple of minutes to set the 

foundational components of some of the terms we'll be using. Next slide.
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So a facemask is a mask with or without a face shield that covers the user's 

nose and mouth and may or may not meet fluid barrier or filtration efficiency 

levels. Face masks are to be used for source control only and are not personal 

protective equipment.

An N95 respirator is a disposable half-mask filtering face piece respirator that 

covers the user's airways, nose and mouth and offers protection from 

particulate material at an N95 filtration efficiency level both 42 CFR 84.181. 

Generally, an N95 FFR used in a healthcare setting is regulated by the FDA 

under 21 CFR 878.4040 which is FDA product code MFH.

And is either a Class 2 device that is exempt from premarket notification or is 

a Class 2 cleared device. And NIOSH, of course, also provides oversight and 

can evaluate and approve N95 respirators. Next slide please.

A face shield is a device used to protect the user's eyes and face from bodily 

fluids, liquid splashes of potentially infectious materials. Generally, a face 

shield is situated at the crown of the head and is constructed with plastic that 

covers the user's eyes and face.

And a surgical mask is a mask that covers the user's nose and mouth and 

provides a physical barrier to fluids and particulate materials. The mask meets 

certain fluid barrier protection standards in certain Class 1 and Class 2 

(flammability) tests. Next slide.

For the rest of today we'll be predominately focusing on the N95 respirators. 

However, I did want to make sure everyone was aware of FDA's facemask 

and respirator guidance. An update to the guidance was published last month 

which summarizes our enforcement policy for facemask and respirators 
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during the COVID-19 public health emergency.

It provides regulatory flexibility. And some information regarding when 

certain products require FDA review prior to marketing and under what 

circumstances the products can be marketed without FDA review. They also 

assure that the products are appropriate for their use.

There is also a description of the enforcement discretion as to certain FDA 

requirements. And as mentioned, it's in effect for the duration of the public 

health emergency. We also held a webinar on April 6 concerning the topics 

contained in this guidance. The slides and transcript are available on FDA's 

Web site. Next slide.

I will now hand it off to Dr. Suzanne Schwartz to cover the emergency use 

authorizations for respirators.

Dr. Suzanne Schwartz: Thanks Bill. Bill just mentioned the enforcement policy guidance that 

we've issued for face masks and respirators during the COVID-19 public 

health emergency. A complementary tool that FDA has used extensively in 

this pandemic response is the EUA.

The EUA has a specific construct which is based on the statutory authority 

given to FDA. We'll break that down into its component parts on the next 

slide; next slide please.

What is the basis for EUA and how does it work? Before FDA may issue an 

EUA, the HHS Secretary declares that circumstances exist justifying the 

authorization. During the COVID-19 response, this declaration has been based 

on a determination by the Secretary that there's a public health emergency.
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The specific statutory language can be found in Section 564(b) of the Federal 

Food and Drug Cosmetic Act for those who are interested. You will note that 

this information is included in the introductory framing of every letter of 

emergency use authorization that FDA issues.

The EUA authority allows FDA to help strengthen the nation's public health 

protections by facilitating the availability and use of critical medical products 

during public health emergencies when certain criteria are met. The criteria of 

issuance are the very foundational elements of the EUA;

and similarly, are included in this template of every letter of authorization. 

Number 1, that the condition is serious or life-threatening. Secondly, that 

there's evidence of effectiveness in diagnosing, treating, or preventing the 

serious life-threatening disease or condition.

The language which appears in the EUA is crafted as “may be effective”. And 

this is important to note because the EUA establishes a different threshold for 

evidence that is distinctly different from an FDA clearance or approval.

Third, that the known and potential benefit for the authorized product when 

used as authorized, outweigh the known and potential risks. And finally, that 

there is no adequate, approved and available alternative to the emergency use 

of the product.

This applies at times of respirator shortages for healthcare personnel as we 

have experienced during the COVID-19 pandemic. Next slide please.

The presence of significant national shortages of respirators during the height 

of the pandemic with rapidly increasing numbers of COVID-19 cases and 

inadequate supply to protect healthcare personnel serves as a very important 
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backdrop to further contextualize why FDA issued three respirator EUAs,

each of which has specific criteria outlining eligibility as well as denoting the 

scope and conditions of authorization.

The first EUA we issued in early March covers all NIOSH approved 

respirators. The second EUA we originally issued in late March authorized 

non-NIOSH approved disposable FFRs imported to the US, exclusive of 

product manufactured in China. It has since been updated and we'll cover 

those updates shortly.

The third EUA we originally issued in early April. And it authorized nonNIOSH approved disposable FFRs manufactured in China. It has also been 

updated and we'll cover those updates shortly.

The issuance of these three EUAs illustrates FDA's constant attention to the 

evolving needs of healthcare personnel, making every effort to address 

shortage concerns, and at the same time, ensuring that product which is made 

available to our healthcare workforce is indeed providing adequate respiratory 

protection. Next slide please.

Included within the scope of the NIOSH EUA are: NIOSH approved, nonpowered air-purifying particulate FFRs. Most commonly, these are the N95s 

as well as reusable respirators such as elastomerics. Number two, NIOSH 

approved PAPRs. Number three, FFRs that have since passed their 

recommended shelf life, that are not damaged, and they've been maintained in 

conditions that are appropriate in strategic stockpiles. And finally, FFRs that 

have been decontaminated by an authorized decontamination system. Next 

slide please.

On June 6, we updated the EUA for imported non-NIOSH-approved 
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disposable FFRs. The updates included revisions to the Scope of 

Authorization as well as the Criteria for Eligibility. Authorized respirators are 

listed in Exhibit 1 of the EUA.

Of note, no changes to Exhibit 1 resulted from the revisions to the EUA. FDA 

has however revised the Scope of Authorization in that decontaminated 

respirators with exhalation valves are no longer in the scope of product 

authorized by this EUA. Next slide please.

This second slide pertaining to the imported non-NIOSH approved disposable 

FFRs depicts the updated eligibility criteria. Criterion 1 remains as is. 

Criterion 2 was revised to confer eligibility to those FFRs that conform to 

either the PPE directive or to the PPE regulations depending upon the date 

when the FFR was put into distribution, as evidenced by a CE mark.

And Criterion 3 was newly added and confers eligibility to those non-NIOSH 

approved FFRs manufactured by NIOSH approval holders. Those of you 

who've been closely following the issuance of FDA's EUAs on respirators will 

recognize this criterion as it mirrors one already included in the EUA for 

FFRs manufactured in China. Next slide please.

On June 6, we updated the EUA for non-NIOSH-approved disposable FFRs

manufactured in China. The update included revisions to the Scope of 

Authorization, Conditions of Authorization and Eligibility Criteria. Let's walk 

through the Eligibility Criteria changes first.

Criterion 1 remains unchanged. Criterion 2 was revised to limit the 

jurisdictions to only those FFRs that conform to either the PPE directive or the 

PPE regulation, as evidenced by CE mark or it has an NMPA registration 

certification.
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Criterion 3 was further revised from the May 7th EUA update to state that for

respirators sampled by FDA and tested by NIOSH per the FDA NIOSH 

sampling plan of 30 respirators, should one respirator’s filtration performance 

be less than 95%, that results in a failure of that model and the respirator will 

not be authorized.

In addition to the revised Eligibility Criteria, FDA revised the Scope of 

Authorization to remove decontaminated respirators. And also added new 

Conditions of Authorization to require samples for testing when requested by 

FDA and to prevent distribution of shipments that failed testing, as I 

previously described.

Next slide please. We have now completed a high-level walkthrough of the 

three respirator EUAs and their recent updates. The corresponding lists of 

authorized respirators are dynamic, and we encourage you to periodically 

check these lists for additions and removals as they are posted publicly.

For the NIOSH approved respirators, a link to the NIOSH's publicly facing 

CEL, Certified Equipment List, is embedded in the EUA.

Exhibit 1 and Appendix A are updated regularly as the FDA team receives 

new requests and evaluates them for authorization under the corresponding 

EUA.

Through these respirator EUAs we continuously strive to meet the evolving 

needs of healthcare personnel. We are continuously re-examining the supply 

landscape by engaging with our federal partners and the private sector to best 

understand the state of product availability for healthcare across the nation.
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And with an unwavering commitment to our public health responsibility, we 

are continuously redoubling our efforts to ensure that our healthcare 

workforce who put their own lives at risk have access to respirators that 

provide the necessary respiratory protection. Next slide please.

Our efforts are not in a vacuum. We work closely with our federal partners, 

CDC NIOSH and OSHA so that strategies for optimizing the supply of N95 

respirators are broadly disseminated and communicated whenever we have the 

opportunity. Next slide please.

These strategies are well detailed in the CDC NIOSH recommendations and 

explain recommended measures healthcare facilities can take commensurate 

with the circumstances, be they conventional, contingency or crisis.

Of highest preference, FDA cleared or NIOSH approved N95 respirators 

should be used when they are available. However, when they are not, FDA 

recommends using FDA authorized respirators before any other alternative.

Based upon the data we have evaluated that has informed and will continue to 

inform our EUA revisions, we do not recommend using a product as a 

respirator if it has not been FDA-cleared, NIOSH-approved or authorized by 

FDA for emergency use as a respirator. Such a product could instead be used 

as a face mask to improve source control and help stop the spread of COVID19.

While much emphasis has been placed on filtration efficiency performance,

proper fit of a respirator is paramount in order for it to protect properly. 

Healthcare personnel should ensure that respirators fit adequately before every 

use. It is therefore, important to consider that it may be difficult to achieve an 

adequate fit with respirators that have ear loops instead of head straps.
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I would now like to turn the presentation back over to Bill Maisel who will 

provide an overview of FDA's ongoing efforts to further the optimization of 

supply of respirators.

Bill Maisel: Thanks Suzanne. Next slide please. As mentioned, FDA cleared or NIOSH 

approved N95 respirators should be used when they are available. And when 

they are not available, we recommend using FDA authorized respirators 

before any other alternatives.

A decontaminated respirator should only be used when there are insufficient 

supplies of new approved, cleared or authorized respirators. I want to spend a 

few minutes now talking about some of our policies that we have published 

regarding respirator decontamination and bioburden reduction. Next slide 

please.

Approximately two weeks ago, FDA issued guidance on recommendations for 

sponsors requesting EUAs for decontamination and bioburden reduction 

systems of surgical masks and respirators during the COVID public health 

emergency.

The guidance contained evidence-based approaches to decontamination and 

bioburden reduction. It provides an overview and a proposed recommended 

tiered approach for decontamination and bioburden reduction systems. And it 

provides the recommended content of a pre-EUA submission and EUA 

request. Next slide.

The guidance and our review approach rely on an evidence-based approach to 

assessing decontamination and bioburden reduction. It relies on the wellestablished hierarchy of resistance of microorganisms to germicidal 
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chemicals.

So bacterial spores and mycobacteria are more resistant than non-lipid or 

small viruses are more resistant still then vegetative bacteria and lipid or

medium sized viruses. And importantly the SARS-CoV-2 virus that causes 

COVID-19 falls into the category of lipid viruses.

And so, this hierarchy is applicable to most established microbiocidal 

processes. And the guidance uses the tiered approach for processes that 

follows its hierarchy. If you are using a process about which less is known or 

that is known not to follow this hierarchy, then we recommend that you reach 

out to FDA directly to discuss the evidence that will be needed to support your 

authorization.

But for those processes known to follow this hierarchy, the following slides 

will walk through the type of evidence that is needed for the validation data. 

Next slide please.

The FDA guidance recommends use of a tiered approach to assessing the 

validation data associated with a decontamination process and system. And 

the proposed use of the decontamination system will determine the level of 

evidence needed to support the use. And it is a three-tiered approach.

Tier 1 is the most stringent criteria and that is for decontamination of surgical 

masks and/or respirators for either single or multi-user use. It requires or is 

recommended that you provide at least 6-log reduction of the most resistant 

spores for the proposed process or greater than or equal to 6-log reduction of 

mycobacteria species.

Tier 2 is for decontamination for single user reuse and is recommended that 
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you provide at least 6-log reduction of three non-envelope viruses or at least 

6-log reduction of 2 gram positive and 2 gram negative vegetative bacteria.

And then Tier 3 is for bioburden reduction. Because the level of reduction is 

lower it is only intended to supplement existing CDC reuse recommendations 

and it is not intended to be used in lieu of CDC reuse recommendations.

You can think of it as a belt and suspenders approach. And we recommend 

providing evidence demonstrating as least 3-log reduction of non-envelope 

viruses or at least 3-log reduction of 2 gram positive and 2 gram negative 

vegetative bacteria. Or other evidence such as published literature and other 

scientific studies demonstrating a similar affect. Next slide please.

The validation of decontamination is only one piece of the information that is 

necessary to provide authorization and the recommended content of the preEUA submission and EUA request.

I am not going to walk through each of these items here today, but they are 

described in our guidance in great detail. I will call out a couple of them 

however. Item Number 3 is a description of the process controls including the 

critical cycle parameters.

This includes information such as concentration, time, heat, relative humidity. 

We will want to know about the use of the chemical or biological indicator. 

We will want information that demonstrates that the process is reliable and 

well controlled.

Number 5, the material and respirator compatibility is also key and very 

important obviously for the process. Respirators can vary in design and this 

can have an important impact on the safety and effectiveness of the 
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decontamination system.

Other evidence supporting the number of decontamination or bioburden 

reduction cycles that the respirator can withstand is needed and we will review 

that. And it is important that there be a reassessment of respirator performance 

after a number of cycles including filtration performance, breathability and fit 

testing.

Again, I recommend that you look at the content of the guidance if you are 

considering submitting a pre-EUA or EUA request. Next slide please.

FDA has issued several EUAs for decontamination systems. Each one is 

authorized for use only with compatible N95 respirators. And those respirators 

must meet all of the criteria and this is based on the revised EUAs that were 

issued this past week.

The respirator must be a non-cellular respirator and without an exhalation 

valve. And it must either be authorized in the NIOSH approved air purifying 

respirator EUA or authorized and identified in Exhibit 1 of the EUA for the 

imported non-NIOSH approved disposable filtering safety respirators that Dr. 

Schwartz was talking about.

And again, decontaminated respirators are only for use when there are 

insufficient supplies of FFRs resulting from the COVID-19 pandemic. Next 

slide please.

This provides a list of the currently authorized decontamination systems. The 

details of each system are described in the letter authorizing the EUA as well 

as in the publicly available fact sheet and information sheets that are available 

on FDA's Web site.
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I have provided a link here, but you can go to FDA's EUA Web site. We 

update it daily. We list every authorized system. If there are updates to the 

EUAs they will be posted there and the information that healthcare personnel 

and healthcare facilities need to safely use these products are listed there. Next 

slide please.

I know we provided a whirlwind tour of some of the important updates and 

aspects contributing to the safe use of respirators. We did want to save some 

time for questions. And so, at this point I will turn it over to Suzanne 

Schwartz as we open up the Webinar to the audience for questions.

Suzanne Schwartz: Thanks Bill. Again, at this time we’ve concluded the formal presentation 

portion for today's Webinar. We have our subject matter experts from across 

all three agencies available on standby as well. Operator may I have the first 

question please.

Coordinator: And once again if you would like to ask a question over the phone please 

press star then 1. Please unmute your phone and record you name. If at any 

time your question has been answered you can remove your request by 

pressing star 2.

Once again that is star 1 for questions at this time. Please stand by Miss. Our 

first question is from Ms. (Hewett). Your line is open.

Ms. (Hewett): Good afternoon. Thank you so much for taking my question and for 

organizing the Webinar series. My question is associated to a comment that 

Dr. Schwartz had mentioned that the respirators that did not pass fit testing 

could be used as face masks for source control.
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My question is associated to that statement. How does that fall or how would 

you consider that considering that the FDA has said face mask EUA 

associated to labeling for face masks? There are six requirements associated to 

the labeling for face masks before that - that these face masks need to comply 

with for them to be used as source control.

Suzanne Schwartz: Thank you for the question. So, I would certainly refer you to the guidance 

that we referenced during the context of the Webinar which includes face 

masks and respirators and has links to the face mask EUA, umbrella EUA.

It is certainly something that you can follow and identify if you have any 

particular questions beyond what is included within the EUA itself or within 

the guidance. Please write to the email address that is on this slide right now 

and we can provide further clarity.

Ms. (Hewett): May I ask...

Suzanne Schwartz: Let me also just add one other point and that is that cloth facial coverings and 

face masks do not need to be under an EUA. There are plenty of them that are 

being used that are not under an EUA. So, let me hear what your follow up 

question was.

Ms. (Hewett): And the follow up question is actually to that point, the comment that you just 

made. There is a lot of confusion if I could be frank with you associated to the 

EUA face mask umbrella. And I have submitted some questions through your 

consumer services and to the email and I have been awaiting some answers.

It seems that the language is not, or the guidance may not be aligned with the 

CDC and also with the EUA umbrella. An example would be that we do have 

various respirators that have not either met the fit testing criteria, the imported 
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respirators or have not been NIOSH approved and have passed the modified 

testing.

That there is a statement that from the FDA stating that they could be used as 

source control. However, we are not clear though if we would want to use 

these (unintelligible) 95 specifically that have not met any (unintelligible) 

criteria of source control. If they would have to fall under this EUA umbrella, 

face mask umbrella.

It seems that there is some communication, a point that they have to fall under 

that umbrella. But other messaging and messages that are coming across that 

they do not need to fall under that umbrella to be used as source control in a 

healthcare setting.

Suzanne Schwartz: Thank you for that. I am going to ask if one of the subject matter experts 

from FDA wouldn't mind taking that question further. It might be either 

CAPT Claverie or Dr. Ashar.

Binita Ashar: Sure, this is Binita Ashar. So as Dr. Schwartz mentioned there are two 

documents that you have referred to. One is the guidance allowing increased 

supply of face masks. And the second is the umbrella EUA for face masks.

If the company or if the Sponsor wants to go ahead and market these as a face 

mask they should follow the guidance. And there are certain recommendations 

there pertaining to the labeling. It is very important to us and I think to others 

using these devices that they know what these devices are doing, and they 

should not be used as surgical masks for example.

So, we have some labeling recommendations included in that guidance that I 

would advise your colleagues to follow. Now if the individual that is 
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marketing this mask seeks to go one step further and assure that they have the 

liability protections associated with emergency use authorizations, then they 

should follow those conditions laid out in the emergency use authorizations.

So they may not entirely match the stipulations of the guidance and the 

emergency use authorization but they are very closely aligned.

Coordinator: Thank you. The next question comes from - the next question comes from 

*(Jennifer Bettencourt). Your line is open.

(Jennifer Bettencourt): Hi good afternoon everybody. Thank you so much for this informative 

Webinar and update. At our organization we did put together a pretty 

thorough for the reprocessing of the N95 disposable masks. We will be 

stopping that - actually this week because we have adequate PPE and we will 

not continue reprocessing those masks.

However, we are now exploring the process for the disinfection and cleaning 

of the elastomeric half face respirators as well as using air powered purifying 

respirators. And we have been in contact with the vendor. They have been 

very forthcoming and helpful.

However, for my quality piece which is what I try and help and provide 

support here for the organization on. Should we be providing the 

decontamination or cleaning of these half elastomeric respirators or should we 

be leaving that responsibility up to the end user that will own the face mask?

Suzanne Schwartz: Thank you for that question and I am actually going to turn that over to 

NIOSH. I am wondering if Dr. D'Alessandro, one of your colleagues might 

address the reprocessing, disinfection reprocessing of the elastomerics.
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Maryann D'Alessandro: Hello Suzanne and thanks for doing this. Yes, we have prepared 

guidance for those who are decontaminating respirators per the crisis capacity 

strategy situation.

So, our recommendation would be that you allow the users to make that 

decision in working with the manufacturers and if they are in that crisis 

capacity strategy using the guidance that we have on the Web. We understand 

that some are enabling that guidance to be used for conventional operations as 

well. This is not our intent.

Jennifer Bettencourt: Thank you.

Suzanne Schwartz: Thank you. Next question please.

Coordinator: Yes, the next question comes from (Victor Schwartz). Your line is open.

(Victor Schwartz):Thank you just a basic question. Do any of the N95 masks and this is a 

common question that I am asked all the time. Actually protect the user? 

Regardless of what is said in some of these TV shows. Do any of them protect 

the user against the virus as well as providing protection to those around 

them?

Suzanne Schwartz: Maryann do you want to answer that one?

Maryann D'Alessandro: Yes, this is Maryann. Actually, respiratory protection is meant to protect 

the user not to be a source of control. For example, if a respirator does have an 

exhalation valve then you would not use that as protecting a patient or those 

around the individual. So, at this point in time we are conducting research to 

evaluate comes out of the exhalation valve and all. But the respirators do 

protect the wearer not those around them.
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(Victor Schwartz):Thank you.

Coordinator: Thank you. The next question comes from (Meg McGucci). Your line is open.

(Meg McGucci): Yes, good morning. I have a very specific question. Is the exhalation valve the 

same thing as the cool flow valve that can be a 8511 N95 respirator?

Suzanne Schwartz: NIOSH I think this question is for you please.

Maryann D'Alessandro: This is a manufacturer specific question. I do not know that specific 

valve, but I expect that it is. Whoever your manufacturer is of that respirator I 

would suggest that you talk to them, but I believe that is an exhalation valve.

(Meg McGucci): And so, this is a NIOSH approved equipment and we are currently using UV 

sanitizing. Is this something that we are not able to do anymore? This is the 

update. Is that what we are talking about?

Maryann D'Alessandro: Is that - so I am sorry what is that product? It is a NIOSH approved 

device but what is the product itself?

(Meg McGucci): (Unintelligible) 8511 NIOSH approved. It is on the list of approved products. 

It has a cool valve in the center of the mask and currently we are UVC 

sanitizing these masks. And my question is are we no longer able to do that?

Maryann D'Alessandro: If you are still in the crisis capacity situation you should be able to do 

that. Otherwise you should leave it up to the manufacturer who I believe is 

3M for that product. You can check with them on whether or not that would 

be authorized.
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Suzanne Schwartz: And this is Suzanne Schwartz. Let me also add a little clarification. The 

decontamination systems that FDA has thus far authorized that we covered in 

this update happen to all be related to hydrogen peroxide or vaporized 

hydrogen peroxide excuse me. They do not cover UV light.

So, the discussion that we have had, the update is in the context of the 

decontamination systems. The modalities that have been thus far and have 

been authorized thus far.

(Bill Maisel): Suzanne this is (Bill Maisel) just to clarify. We have also authorized one 

steam decontamination system.

Suzanne Schwartz: Yes. Correct thank you.

Coordinator: Thank you. The next question comes from (Mike Nolan).

Maryann D'Alessandro: I am sorry before you get to the next question this is Maryann. 3M also 

has published a fact sheet on their Web site regarding what products are able 

to be decontaminated with their respirators. So I would suggest you look at 

that as well.

(Mike Nolan): Okay this is (Mike Nolan). Thanks for taking the question. The COVID 

emergency calls for many more respirators but the next emergency may call 

for something entirely different.

So my question is, is the FDA going to manage the EUA type situation using 

the existing FDA's UDI or Unique Device Identifier systems which are 

designed for medical devices? This is a system that is now being used by 

manufacturers, healthcare providers of Class 1, 2, and 3 medical devices. It is 

intended to provide quality assurance and traceability of medical devices.
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It relies on the FDA's GUDID database and many companies are integrating 

the UDI system into their supply chains. So, it seems to make sense to help 

manage these products. Even the emergency products as well as the normal 

activity using the same methods that are now being implemented in healthcare 

supply chains. So, the question is, is that under consideration?

Suzanne Schwartz: So I will start off but then I am going to ask if (Bill Maisel) might want to 

add or further enhance the response. FDA will use all these different types of 

tools and leverage existing databases and mechanisms to help support our 

emergency response, regardless of what the hazard is. There is no question 

around that. And UDI would be a tool that could be utilized.

I think what is unusual in terms of COVID-19 - - and the criticality of the 

shortages that have been observed - - is that some of the products that we are 

talking about expand well outside the bounds of what has been in a traditional 

medical device manufacturing space in terms of whether it would have even 

been in UDI.

So, you know, we have to pull out all the stops, if you will. And use the 

various levers that we have, UDI being one of them, but to the extent that 

there are three EUAs for the very reason that limiting it to, for example, FDA 

cleared or NIOSH approved respirators, was going to be thoroughly short of 

what the needs are, what the demand is, and needing to expand that out and 

out further is illustrative of how we have to, you know, consider other avenues 

and other approaches.

Coordinator: Thank you. Our final question for today will come from (Cory) your line is 

open.
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(Cory): Thank you. I work for a manufacturer, a non-NIOSH-approved manufacturer. 

We are going through the formal process to become a non-NIOSH approved 

manufacturer in addition to getting our factories registered. We submitted our 

original EUA application for non-NIOSH approved built-in safety system 

from China on 3/31 and have received, I would say less than desirable 

communication from the FDA.

And I was wondering if you could speak and provide some clarity and 

visibility as to what the process internally looks like once you receive an EUA 

request, specifically looking at the 40-plus manufacturers that were removed 

from the Appendix A during the April 7th revision.

In addition to - or was it the May 7 revision - but also an understanding of 

how those manufacturers were able to get their products added back onto the 

Appendix A, as there are still manufacturers like mine that has yet to receive a 

formal response on our EUA dated back to 3/31.

Thank you.

Suzanne Schwartz: Thank you. Thank you for the question.

So, first of all here, we want to be able to provide you a timely response. In 

some cases - - and potentially this falls into the circumstances you're 

describing - - the documentation that was received by the agency has not been 

- we've not been able to full vet the information. And the Criterion 3 as you 

described in the China EUA has provided a fair amount of challenge to this 

space.

We'd be happy to engage you further in a separate conversation to better 

understand exactly the circumstances that you're facing and try to, you know, 
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to resolve that.

So, I think that we are over time. And I do want to say that on behalf of FDA, 

I want to first acknowledge our valued partners from NIOSH and OSHA. 

Between us - we together have been able to, and will continue to, drive 

towards meeting our common vision and mission of protecting the public 

health.

Thank you to everybody who has tuned into this webinar. It's the first of many 

in this series. We're looking forward to exchanging dialogue and keeping you 

informed and hearing your perspectives and questions.

The next session, as (Bill) mentioned, will be June 23rd, in two weeks at noon 

Eastern, and announcements of topics will be forthcoming.

I'd now like to turn the session back to Irene who will close it out.

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 CDRH Learn webpage at www.fda.gov/training/CDRHLearn 

by Wednesday, June 17th.

If you have additional questions about today's presentation, please use the 

contact information provided at the end of the slide presentation. As always, 

we appreciate your feedback.

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

question survey about your FDA-CDRH webinar experience. The survey can 

be found at www.fda.gov/CDRHWebinar immediately following the 

conclusion of today's slide webinar.
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Again, thank you for participating. And this concludes today's webinar.

Coordinator: Thank you all for your participation on the conference call today. At this time, 

all parties may disconnect.

END