FDA Webinar

Moderator: IRENE AIHIE

09-01-20/12:00 pm ET

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FDA Webinar SeriesCDC/NIOSH's Surgical N95 Respirator Guidance

Moderator: Irene Aihie

September 01, 2020

12:00 pm ET

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

listen-only mode until the question and answer session of today's call. At that 

time if you would like to ask the question please, press 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 our meeting over to Ms. Irene Aihie. 

Thank you. You may begin.

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

CDRH's Office of Communications and Education. Welcome to the seventh 

CDRH Webinar in our Respiratory Webinar series. During today's webinar, 

CDC NIOSH will present information on the recent release of its updated 

surgical respirator guidance, and representatives from CDC NIOSH, FDA, 

and OSHA available to answer questions. 

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

related to information provided during today's discussion. Now, I give you Dr. 

Suzanne Schwartz Director of CDRH's Office of Strategic Partnerships and 

Technology Innovation.

Suzanne Schwartz: Thank you and welcome everyone. As Irene mentioned, this is the seventh 

session in our biweekly webinar series on personal protective equipment or 
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PPE. At our last webinar on August 18, Dr. Binita Ashar -- Director of the 

Office of Surgical and Infection Control Devices or OHT 4 in CDRH's Office 

of Product Evaluation and Quality or OPEQ -- discussed the Umbrella EUA 

for surgical masks and how it fits into FDA's holistic regulatory approach to 

surgical masks.

Today I'm pleased to introduce Colleen Miller -- Deputy Chief Conformity 

Verification and Standards Developing branch from CDC NIOSH's National 

Personal Protective Technology Laboratory -- and Heidi Sewchok -- NIOSH 

Approval Coordinator -- who will provide an overview of the recently updated 

NIOSH guidance on surgical respirators.

After their presentation, we will turn to the Operator for live Q and A. Our 

federal partners and colleagues from CDC NIOSH and OSHA are on the line 

with us and they're available to field questions relevant to their respective 

mission, roles, and responsibilities. At this time I'd like to turn the webinar 

over to Colleen Miller.

Colleen Miller: Thank you, Suzanne. I am happy to be here today. It is my pleasure to be 

representing my branch and the National Personal Protective Technology 

Laboratory. I will be giving a brief overview of our agency and then dig into 

the topic of interest today. Surgical N95 filtering facepiece respirators and the 

guidance we recently updated regarding NIOSH approval for them. Next 

slide, please.

I am pleased to have two colleagues in the speaker room with me today. As 

Suzanne mentioned our Approval Coordinator -- Ms. Heidi Sewchok -- is with 

me and one of our new General Engineers -- Ms. Ashley Whitson -- is also 

here. Heidi has been involved in this effort for the last two years and is 

working with Ashley to review these types of applications, and we are just so 

fortunate to have achieved getting Ashley on board during this COVID 

response. Next slide, please.

Just to give a very brief introduction to our agency for those of you less 
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familiar with the National Institute for Occupational Safety and Health --

NIOSH -- the National Personal Protective Technology Laboratory -- NPPTL 

-- is a division of NIOSH and is charged with executing the functions of the 

NIOSH respirator approval program. NIOSH is part of the Centers for Disease 

Control and Prevention, and along with the Food and Drug Administration, is 

part of the Department of Health and Human Services. Next slide, please.

NIOSH has several divisions of laboratories across the United States. The 

NIOSH Office of the Director -- Dr. John Howard -- has staff located in 

Washington, D.C. and Atlanta, Georgia. NPPTL has offices in Pittsburgh, 

Pennsylvania, and Morgantown, West Virginia. Other NIOSH locations 

include Cincinnati, Ohio, Denver, Colorado, Spokane, Washington, and 

Anchorage, Alaska.

The bulk of the respirator approval program work is completed in Pittsburgh, 

Pennsylvania. Virtually now for those of us involved in the documentation 

review side of the program and on-site for our colleagues in the Evaluation 

and Testing Branch, that are conducting the respirator testing required. Next 

slide, please.

NIOSH approved all respirators used in U.S. occupational settings in 

accordance with the Code of Federal Regulations 42 CFR Part 84, standard 

test procedures, standard application procedures, and policies. Today's focus 

is on surgical N95 respirators.

As you can see from this slide, surgical N95's are a very small fraction of the 

work we accomplish in the NIOSH respirator approval program. We approve 

self-contained breathing apparatuses, supply air respirators, power airpurifying respirators, closed-circuit escape respirators, and other air-purifying 

respirators.

As described today, a surgical 95 respirator is a NIOSH approved N95 

filtering safety respirator that additionally conforms to recognized standards 

for biocompatibility, flammability, and fluid resistance, and is thus intended 
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for use in healthcare settings within as well as outside of the operating room. 

A surgical N95 is therefore not limited to use during surgery but is intended 

for use in all other healthcare settings where this type of respiratory protection 

is indicated. Next slide, please.

I need to set the stage a bit so everyone can understand how we arrived to be 

here today. As I said, in the U.S., the Occupational Safety and Health 

Administration -- OSHA -- requires that respirators used in these occupational 

settings are NIOSH approved.

Additionally, respirators used in healthcare-specific to our topic today -- N95 

filtering facepiece respirators -- are considered medical devices by the FDA 

and are cleared through the 510(k) Premarket Notification program. As we 

speak, all surgical N95's used in healthcare today are approved and cleared for 

use by both agencies NIOSH and the FDA. The applicant first applied for and 

obtained NIOSH approval and then sought and achieved FDA 510(k) 

clearance.

Back in 2016, NIOSH NPPTL sponsored a National Academy of Medicine 

workshop to discuss surgical N95 regulatory and performance requirements. 

After the workshop in 2017, the agencies NIOSH, NPPTL, and the FDA 

Center for Devices and Radiological Health -- CDRH -- finalized a 

memorandum of understanding with the intent to streamline this regulatory 

process and reduce redundancy.

We worked together to develop a process for NIOSH to complete the full 

review of devices submitted to NIOSH under the terms of the MOU, and in 

late 2018, NIOSH posted guidance outlining the process for executing the 

MOU. At that time, the guidance said the devices approved under the 

consolidated MOU process would be labeled and referred to as N95-Fs. 

NIOSH discussed the guidance and process with stakeholders but did not 

receive any applications to review. Then as the COVID-19 response started 

gaining momentum, approval holders and potential applicants began to ask 
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more about the MOU consolidated process. Next slide, please.

We became concerned during the COVID-19 response that we as a nation did 

not need yet another classification to identify this type of basic respiratory 

protection used by healthcare workers, so we discussed this concern with our 

FDA colleagues and began to update our guidance.

The guidance was revised and now better aligns with the MOU and refers to 

these devices as surgical N95 filtering facepiece respirator as SN95's, our 

focus for today's webinar. NIOSH posted an updated guidance about two 

weeks ago and this August 2020 guidance supersedes what we posted in 

November of 2018.

In the fall of 2018 when we posted this guidance, we expected to be working 

through the process with the first applicant and yet we did not receive any

applications, so here we are. I'm sure some of you attending today are already 

working on your application or plan to apply for surgical N95 FFR approval. I 

am providing the slides so that you can see - excuse me. Next slide, please.

I am providing this side so that you can see what the guidance looks like. This 

is the cover page for the NIOSH Conformity Assessment Letter to 

Manufacturers. This is the document that I have referring to as the NIOSH 

guidance. You can see it is marked as being posted for the first time in 

November of 2018 and then revised in August 2020. NIOSH applicants must 

use this updated guidance since -- as I said -- it supersedes the 2018 version. 

Next slide, please.

This is the cover page for another NIOSH Conformity Assessment Letter to 

Manufacturers. This one was published a week or so ago to inform about 

NIOSH NPPTL's prioritization process for applications as we begin to accept 

surgical N95 approval applications. Our top priority is domestic approval 

holders submitting a new or an extension application, including a new or

extension application using the SN95 guidance.
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We also continue to prioritize quality assurance applications from existing 

approval holders to facilitate filtering facepiece respirator, air-purifying 

respirator and powered air-purifying respirator production at additional 

manufacturing sites in accordance with established and NIOSH approved 

quality assurance systems. I encourage participants interested in reading the 

complete notice to visit our website. Next slide, please.

So, I have been referring of it to the term applicant or application. Just to 

clarify, NIOSH defines the applicant is an individual, a partnership, a 

company, a corporation, an association, or other organization. The applicant 

designs or controls the respirator design, manufacturers assembles or controls 

the assembly of a respirator and may apply to NIOSH to become an approval 

holder. Thus, once approved, the applicant becomes the approval holder. Next 

slide, please.

So, as I said, we have updated our surgical N95 filtering facepiece respirator 

guidance and our prioritization process. So in our revised guidance, we have 

defined four scenarios to guide applicants and approval holders. In the first 

scenario, we state that no immediate action under this guidance is required for 

an existing device that has previously obtained NIOSH approval and FDA 

510(k) clearance.

The existing approval will remain effective as long as the approval holder 

continues to one, pay the annual NIOSH maintenance fees; two, register and 

list your company with the FDA; and three, meet NIOSH and FDA 

postmarket requirements.

The approval holder will be expected to revise their user instructions and 

packaging to include the new cost in limitation S and remove the P's as 

defined in this guidance -- and Heidi will talk about that a bit later -- the next 

time that approval is submitted for an extension for approval. 

And in some cases, the approval holder must update the abbreviated label as 

well. Additionally, if the device is private labeled, the approval holder seeks
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to update their labeling, they must submit an extension application to update 

their approval and all the private labeled versions.

The second scenario is defined as if a manufacturer of an existing NIOSH 

approved N95 filtering facepiece respirator has not previously sought FDA 

510(k) clearance and now seeks to label a device with the additional 

protection of flammability, fluid resistance, and biocompatibility, the 

manufacturer must follow the guidance to achieve a new NIOSH approval for 

the surgical N95 respirator.

The third scenario identified is if a manufacturer of an existing NIOSH 

approved N95 filtering facepiece respirator has not previously sought FDA 

501(k) clearance and does not seek to label the device for those additional 

protections of flammability, fluid resistance, and biocompatibility, the existing 

NIOSH approval will remain effective as long as annual fees are paid.

And the final scenario, if a manufacturer of a new N95 filtering facepiece 

respirator seeks NIOSH approval for a surgical N95, the manufacturer must 

follow this updated guidance. Now I will turn the mike over to Heidi Sewchok 

so she can continue to inform you about the approval process.

Heidi Sewchok: Next slide, please. Hi, everyone. I'm Heidi Sewchok, the Approval 

Coordinator for the respirator approval program. Along with Ashley Whitson, 

we will be conducting the reviews of the surgical N95's that are submitted to 

NIOSH. I'm going to walk you through some of the basic steps for surgical 

N95 approval under the MOU. The process follows a similar path to the 

typical NIOSH N95 approval. However, there is more information that needs 

to be provided.

The first step that an applicant must take is to perform the required 

presubmission testing. This is often erroneously referred to as precertification 

testing. While it is required prior to approval, it does not indicate that the 

respirator is capable of achieving NIOSH approval. This is because the 

NIOSH approval encompasses both the performance and the quality assurance 
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aspects and they cannot be considered independently from one another.

The testing required from NIOSH for an N95 filtering facepiece includes 

inhalation resistance, exhalation resistance, and particulate filter efficiency. 

This testing can be performed by a third party or the applicants themselves if 

they are capable and have the appropriate equipment.

The additional tests to achieve the surgical designation for an N95 must be 

performed by a lab that is certified to the FDA's Good Laboratory Practices 

requirement. The additional tests are fluid penetration, flammability, and 

biocompatibility. The biocompatibility test itself consists of three individual 

evaluations which are cited toxicity, sensitization, and irritation. Next slide, 

please.

The second step is to prepare the required documents and submit the 

application to NIOSH following the standard application procedure and the 

updated guidance. Final packaging should also be included with the 

application package. After the application package is received by NIOSH, the 

FDA requirements defined by the MOU will be evaluated by NIOSH.

After the application package is determined to meet the MOU requirements, 

the NIOSH evaluation and testing will continue per our typical process, 

including initial review, quality assurance review, testing, and final review. If 

a site qualification is required, that will also be coordinated during quality 

assurance and final review.

If the application package is deemed to meet the requirements of 42 CFR Part 

84 and the MOU, a surgical N95 approval will be issued and the NIOSH CEL 

-- Certified Equipment List -- will be updated to reflect the approval as a 

surgical N95. After receiving approval from NIOSH, the approval holder is 

responsible for listing the device with the FDA. Next slide, please.

Ashley and I wanted to include a bit of information about the quality 

assurance requirements found in 42 CFR Part 84 because it is an often 
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overlooked aspect of the NIOSH approval that raise many - leads to many 

application failures. We are hoping to post more detailed information --

perhaps as a frequently asked question and answer page -- to better guide 

applicants.

Today I am able to give a broad overview of some of the information that we 

expect to see from applicants. The quality requirements are different than 

other certification bodies that many are used to working with and the 

requirements that we look for are outlined in our regulation and are very 

specific. The quality manual submitted to NIOSH must meet the requirements 

outlined in our Conformity Assessment interpretation notice NIOSH CA 

2019-1019 and 42 CFR Part 84.

In addition to the quality manual, a comprehensive quality control plan must 

be supplied and must be sufficient to determine that the respirator meets the 

NIOSH performance requirements and the specifications that were presented 

for approval.

For a filtering facepiece, inspections receivers should include incoming and 

final inspections. These inspections must be assigned classification of defects. 

This is a hang-up that many experience as the classification of defects defined 

in 42 CFR Part 84 are different from those used by the common sampling 

plans. The definitions in the regulations must be appropriately applied to be 

acceptable.

Incoming inspections procedures must be clearly defined and serves to verify 

that the materials received conform to the specifications that were ordered. 

Final inspection procedures must be clearly defined and serves to verify that 

the fully assembled respirator conforms to the specifications on the drawing 

and ensure that the required performance specifications are met.

Product quality control plans and sampling plans should also define what the 

manufacture or applicant considers to be a lot or a batch. The sampling plan 

used for each inspection should be clearly stated. 
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If a sampling plan other than those commonly recognized by NIOSH is used, 

the equivalency must be explained in the application. The September 24, 2012 

letter to all manufacturers provides more information on the sampling plans 

that are commonly recognized and how to successfully utilize them to meet 

the requirements and expectations. In general, it is expected that the applicants 

meeting NIOSH quality assurance requirements are also able to satisfy the 

FDA quality assurance requirements. Next slide, please.

We also think that it's important to remind everyone that the surgical N95 

approved under the streamlined process must not exceed the threshold 

evaluation criteria outlined in the MOU. Respirators that have certain designs 

or claims are not 510(k) exempt and will need to be evaluated by the FDA. 

Some examples are respirators with exhalation valves or designs that are 

different from what the FDA has previously cleared.

This includes those with novel head suspensions such as adhesive masks and 

those with ear loops, specific disease and/or infection prevention claims, 

specific viral or bacterial filtration performance claims, antimicrobial or 

antiviral functions -- including nanoscale technologies -- (hypoallergenicity) 

claims, filtration of surgical smoker plumes, nanotechnology, drug delivery 

systems, claims of sterility, and any respirator that is not a filtering facepiece 

with the protection of N95. The MOU has a more comprehensive list if you're 

still curious. Next slide, please.

The surgical N95 guidance has specific information about how the respirator 

must be labeled. This information is probably the biggest difference from 

what was posted in 2018. Surgical N95 respirator approval labels must include 

the caution and limitation (S) defined on the approval label as special or 

critical user instructions and/or specific use limitations applied refers to user 

instructions before donning.

The user instructions and packaging must state that this respirator has been 

approved as a NIOSH N95 filtering facepiece respirator for use in healthcare 
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settings as a surgical N95 respirator conforming to recognize standards for 

biocompatibility, flammability, and fluid resistance.

This statement will be found under the (S) special or critical user instructions 

heading. The approval label should no longer have the caution and limitation 

“P”, which is NIOSH does not evaluate respirators for use of surgical masks, 

which is common on all existing N95 respirators.

The updated guidance also provides specific information that will appear on 

the abbreviated label, which is the label that is printed on each individual 

filtering facepiece. The abbreviated label will include additional wording to 

inform users that the respirator is appropriate for use in healthcare settings.

The abbreviated label will have the words surgical N95 respirator directly on 

the filtering facepiece. All new surgical N95's will have this on their 

abbreviated label. At the moment, we are not requiring manufacturers who 

already have surgical N95's to make this update immediately.

If they do wish to update their labeling, an extension of approval application 

can be presented to update the abbreviated label, approval label, and user 

instructions. Next slide, please.

We realize we've shared a lot of information today is intended for respirator 

manufacturers. We are working on a respiratory protective device information 

notice to inform users, and the FDA and NIOSH want to remind users that the 

NIOSH approved surgical N95 offers the same respiratory protection as the 

NIOSH approved N95 filtering facepiece respirator.

Additionally, the surgical N95 conforms to FDA specified flammability, fluid 

resistance, and biocompatibility requirements and is intended for use in 

healthcare settings inside and outside of the operating room. A surgical N95 is 

not limited to use during surgery but is intended for use in all healthcare 

settings where respiratory protection is needed to protect the wearer and it 

provides an appropriate level of respiratory protection. Next slide, please.
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Here we have included some links for you today including the links to our 

NIOSH certified equipment list, which is updated at least monthly. We are 

working to define how the CEL can be searched to identify approved surgical 

N95's. The first choice for confirming whether or not a respirator is approved 

should always be the CEL, but we do have an additional page -- the surgical 

N95 trusted resource page -- which can be found using the second link.

You can easily access the electronic version of our regulation 42 CFR Part 84 

and our standard test procedures for air-purifying respirators using the third 

and fourth links. The conformity assessment notices we mentioned throughout 

this presentation and general information about the NIOSH respirator 

approval program can be found using the fifth and final links, respectively. 

Next slide, please.

In closing, I want to let you know as September 5 9-5 as in N95 approaches, 

we are gearing up to celebrate Respiratory Protection Week. You can check 

that out on our NPPTL web page. Our NPPTL health communications team 

has been busy preparing social media content, developing webinars, and 

informational products. We hope you can check out our web page and 

consider joining us next week. Next slide, please.

Along with myself and Ashley, NIOSH FDA and OSHA experts are standing 

by to answer your questions. Questions specific to an applicant or an 

applicant's specific situation will be identified for follow-up by NIOSH or the 

FDA after the webinar.

If you have a question specific to your situation, please reach out to myself 

using the e-mail address provided on Slide 2. If you do not wish to ask 

questions specific to the approval process in this forum, please reach out to 

myself or Ashley. Thank you for your time and attention, and I think we're 

ready for questions.

Suzanne Schwartz: Thank you. Operator, we'll now take questions.
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Coordinator: Thank you very much. If you would like to ask a question over the phones, 

please press star 1 and record your first and last name. To withdraw your 

question, you may press Star 2. Once again to ask a question, please press star 

1 and record your first and last name. Thank you. Just a few minutes for 

questions. All right and our first question I do apologize if I mispronounce 

your name I have (Sadhna Denver). Your line is open

(Sadhna Denver): Great. Thank you very much. One question with the new guidance do you 

define whether if N95 are going to be sterile prior to use or if they are to be 

sterilized are you doing to set a standard of what type of sterilization 

techniques are going to be appropriate. Thank you

Heidi Sewchok: Hi this is Heidi Sewchok. There is no requirement from NIOSH or the FDA 

that surgical N95 be sterile. If you want to make that claim it will be outside 

of the streamlined process.

(Sadhna Denver): So if a hospital decides they like to sterilize an S95 or just a regular N95 what 

you're saying is this that the (unintelligible) hospice it's up to them to define 

whatever they want to sterilize the mask or not. Is that correct?

Heidi Sewchok: Correct. Currently outside...

(Colleen): Hi this...

Heidi Sewchok: Go ahead

(Colleen): Hi this is (Colleen). I was just going to say that from the NIOSH perspective 

we expect you to honor the user instructions that are provided by the 

manufacturer and consult with them because ultimately you could be reducing 

the protection that we are approving the respirator to provide to the user.

(Sadhna Denver): Great. Thanks very much for your answer. Appreciate it.
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Coordinator: Thank you. Our next question is from (Adam Allbright). Your line is open.

(Adam Allbright): Hi, thank you. We are manufacturing masks and going for the approval but 

prior to that we were actually manufacturing the raw materials like (E4) 

tracing materials and if we had - if we currently are selling the (E4) tracing 

materials to a company that had sent out those exact products to GLP certified 

laboratories and already did the proof penetration, credibility and biohazard 

credibility would we be able to piggyback off of that being that we are the 

manufacturer so we could confirm the feedback of the materials or will we 

need to do our own but there are company that had done their own testing and 

things like that.

(Colleen): So from that - this is (Colleen) from the NIOSH - perspective we expect that 

the samples would be made under your quality system.

(Adam Allbright): Okay.

(Colleen): So and I think that perhaps my FDA colleagues might have kind of an idea on 

piggybacking.

Suzanne Schwartz: Hi it's Suzanne this is Suzanne. OHT4, can you take that?

Cynthia Chang: Hi this is Cynthia Chang. I’ll start. Typically we request testing on the final 

finished device and not on raw materials. If there's anything else that my 

colleagues want to add to that, please feel free to jump in, but typically we do 

request testing on the final finished device.

(Adam Allbright): Okay. Thank you.

Coordinator: Thank you. Our next question is from (Dennis Hahn). Your line is open.

(Dennis Hahn): Yes, thank you. Had a question on the connection between of the NIOSH 

approval and then the FDA listing. You have mentioned once the NIOSH 

CEL is updated manufacturers responsible for listing the device, does NIOSH 
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issue the K number for the 510K or is that a separate process for the FDA or is 

there a different identifier for 510K devices joining the listing process.

Suzanne Schwartz: Hi this is Suzanne Schwartz from the FDA. I'm going to ask Marjorie 

Shulman to provide a little bit more information or clarity regarding the 

MOU-described 510K exemption and what therefore is necessary, processwise, for the manufacturer to do upon receipt of NIOSH approval and listing 

on the CEL.

Marjorie Shulman: Hi good afternoon this is Marjorie Shulman. If a - if a 510K is exempt 

from regulation then through listing you enter the exemption number, the CFR 

number, so for example 878.5400 that would go in there we - and the product 

code and that's tied to the regulation that shows that it's an exempt device. So 

if I continue number would not be needed. If anyone wants to add anything 

that's fine.

Suzanne Schwartz: And Marjorie, this is Suzanne I believe that that product code for the 

exemption is going to be MSH as a surgical respirator.

(Marjorie Shulman): Perfect. So that's go in there and then that will show, if exempt 510K 

number is not needed, unlike the products that require 510K then the 510K 

number would go in there. But if it is exempt then that product is exempt and 

that's what's needed.

(Dennis Hahn): Thank you.

Coordinator: Thank you once again as a friendly reminder to ask the question on the phone 

please press Star 1 and record your first and last name. Our next question is 

from (Evan Prekoshure). Your line is open.

(Evan Prekoshure): Hello can you hear me?

Coordinator: Yes.
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(Evan Prekoshure): Hello can you hear me?

Suzanne Schwartz: Yes we hear you.

(Evan Prekoshure): Hi it's (Prekoshure) mispronouncing my name that's why I wasn't sure. 

Questions regarding the MOU and then the extension period that locate the 

specific viral bacterial infiltration performance this would be sent and you 

would have to do a 510K but if under the MOU with this respirator is already 

called a surgical respirator how do you differentiate if you had (unintelligible) 

performance. Is that different name?

Suzanne Schwartz: Can you repeat the last part of the question how to differentiate - I didn't -

I don't know that we caught what you said.

(Evan Prekoshure): Yes. Under your new process, you've already called it a respirator a 

surgical respirator. If somebody has, in addition, a disease or infection 

prevention or bacterial infiltration performance and would like to claim those 

is it still a separate respiratory or how do you differentiate in the market that 

your respirator has more than just some ability and the other two of 

performances. 

Suzanne Schwartz: this is Suzanne Schwartz so Colleen and Heidi I think this is an FDA 

related question and I'm going to turn to OHT4 to provide a response as to, 

you know, first of all what would be required since it does trip the exemptions 

for under the MOU what would be necessary for to the respirator that is 

intending to include additional claims as were specified in the listing.

Cynthia Chang: Hi this is Cynthia Chang, I can start. So if you wish to make some of these 

additional claims such as antiviral or antibacterial, antimicrobial claims as 

noted in the presentation and in the guidance document then you would need a 

510K that would need to be submitted to us at FDA and then you would go 

through that process.

NIOSH approval is still a requirement as part of the special controls for the 
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device. I hope that's helpful and unless my FDA colleagues has anything to 

add please jump in.

(Liz Claverie): Hi this is Liz Claveriethank you, Dr. Chang. Just a few other points in 

addition to what Dr. Chang has said so when you would submit your 510K to 

FDA we would you want to have already worked with NIOSH to seek your 

certification of a respirator and where you would submit to FDA you would 

want to make certain that you had supporting performance that is to support 

any claims that you're making as relates to antimicrobial antiviral antibacterial

any those types of claims as Dr. Chang mentioned.

Suzanne Schwartz: And Captain Claverie and Dr. Chang could maybe comment a little bit 

further then with respect to how then that impacts on labeling of the product,

as I think the questioner was also wanting to know with regard to the 

marketing - how it would be differentiated. So if specific test results, going 

through the review process, were there could you explain, given to the 510K 

what that allows in regards to labeling?

Liz Claverie: That's short of a great follow up. Thank you so much. So yes the label would 

actually be a combination label that it has to be approved by both agencies. So 

NIOSH would approve the respirator section of the label we would approve 

the FDA section of the label and the label would be very specific for whatever 

claims the sponsor has made that has been supported by performance data and 

we would allow those claims on the label.

(Evan Prekoshure): Okay and the last question to previous listing I would also understand the 

question so if I (unintelligible) retention and then it's listed as a surgical 

respirator listing it under FDA what does that really mean and how do you list 

it then under FDA after you get the NIOSH (unintelligible) N95?

(Liz Cleverly): So if I may ask you a clarifying question sir. So are you still speaking of the 

respirator that would have antimicrobial claim...

(Evan Prekoshure): No
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(Liz Cleverly): ...or you speak...

(Evan Prekoshure): No

(Liz Claverie): ...so if you're speaking of just a respirator that doesn't have anti-microbial 

claims...

(Evan Prekoshure): Yes.

(Liz Claverie): ...then it should fall under the MOU with NIOSH and you would follow all of 

the processes and et cetera per NIOSH and (Colleen) I don't know if you want 

to pick up anything from there.

(Colleen): Hi (Liz) I think there's still some misunderstanding about this, even though I 

do appreciate what Marjorie provided I think there's a bit of 

misunderstanding about how they list with you, if I'm understanding the 

question correctly?

(Evan Prekoshure): Yes. It's submitted to New York because the approval of respirator N95 

what is the next step to get it listed as a surgical respirator under FDA. What 

is that process?

(Colleen): So what I heard was you would enter MSH still as the product code correct 

(Liz)?

(Liz Claverie): That's exactly correct and you would need to be registered and listed with 

FDA and you would list as Colleen just mentioned the pro code MSH in our 

systems and we would also be working hand in hand, FDA would also be 

working hand in hand with NIOSH as they approve those.

So you would have to make sure on your end that you are registered and listed 

with FDA and that's the first name go and then we would walk hand-in-hand 

with NIOSH and the sponsor as they get approved for the surgical N95 
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respirators under the MOU.

(Evan Prekoshure): Okay so no additional testing necessary? Is that correct?

(Liz Claverie): So as long as...

(Colleen): So as long as you say within the limitation listing. Yes, sorry (Liz).

(Liz Claverie): Exactly. No we were saying same thing (Colleen) thank you so much.

(Evan Prekoshure): Okay thank you.

Suzanne Schwartz: Let's take a moment. It's probably going to be helpful to all of - our 

listeners with regard to FDA's registration and listing process. I'm going to ask 

Cesar Perez who is available to us in FDA maybe you can provide a little bit 

further information and background to help with regard to the registration and 

listing process. You may be muted. We're not hearing you.

Sean Boyd: This is Sean Boyd maybe I can jump in real quick and say those on the line 

you can add or elaborate. If you've been on our registration and listing 

websites at fda.gov it does provide specific instructions for what data, what 

fields would you need to complete or what information you need to provide 

through that process.

You can also reach out to our Imports and Registration and Listing team using

a general e-mail address that you can send specific questions to if you're 

having difficulty in navigating that process [which is reglist@cdrh.fda.gov]. I 

know that team is very responsive and likely would get back to you and 

resolve any questions or issues that you're having within a day or so.

(Evan Prekoshure): Okay. Thank you.

Sean Boyd: And thank you for the question.
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Coordinator: Thank you. Our next question is from (Karen Milroy). Your line is open

(Karen Milroy): Thank you. Good afternoon. I was just wondering given what I imagine is an 

exceptionally large case of, I mean, NIOSH approval and how long is it taking 

to go from kind of the submission of the application through the approval 

process?

(Collen): Is this a new application?

(Karen Milroy): Yes.

(Colleen): You've never had a NIOSH application?

(Karen Milroy): Yes.

(Colleen): Okay. So during the pandemic, we have been trying to increase efficiency as 

much as we can. At this time I would say, you know, we would, you know, 

accept your application we would begin the initial review and the quality 

insurance review.

And depending on, you know, the state of your documentation and how many 

applications are in-house at the same time and whether or not my NIOSH 

overworked staff has needed leave we would say, you know, like, we would 

like to take two to three weeks.

Again it's subject to change depending on how many come in the door at the 

same time -- will also control that. At that point, we would be looking to if 

you are domestic manufacturer we would be discussing how to do a virtual 

initial site qualification visit we would be preparing to do the testing that 

NIOSH requires and we would be reaching back to schedule those things.

How things proceed after the virtual site qualification visit is completed is 

somewhat in the hands of the applicant. We do identify observations minor a 

nonconformances and major nonconformances. An observation gets zero 
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points, a minor just one and a major just three.

So let's say that you have one site where you're - you're doing your design 

development and manufacturing and you're really we would, you know, do 

our inspections and if you receive zero to one point you would - you can 

achieve your approval. If you receive, you know, two to 11 it would be 

provisionally you have some corrective action and if you have more than 12 

points it is considered nonconforming.

So what happens depends a lot on what those corrective actions are and how 

long they take you to address them. So it's really in your hands at that point 

and, you know, (Karen) if things are good you can issue the approval in 

probably in a week or two of having, you know, gotten through everything 

based on the virtual visit and all the documentation. Heidi do you - actually do 

you have anything to add?

Heidi Sewchok: No that was it you did the overview and really do ask if you have corrective 

actions on your site qualification that you don't rush through them because 

that doesn't do anyone any favors.

(Colleen): Especially, for example ,if training of your employees is involved. That takes 

time and it's worth the time.

(Karen Milroy): Okay. That was very helpful. Thank you.

(Colleen): You're welcome.

Coordinator: Thank you once again as a friendly reminder to ask a question please press 

Star 1 and record your first and last name. Next question is from (Michael 

Sterling). Your line is open.

(Michael Sterling): Hi, hello. So I had a question regarding the exemptions from review under 

the MOC - MOU I should say I believe that someone said designs which are 

different such as novel head suspensions and you mentioned ear loops. Can 
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you elaborate on why ear loops has not been cleared before or that's the case?

Suzanne Schwartz: Hi this is Suzanne Schwartz...

(Colleen): Hi this is...

Suzanne Schwartz: ...I'm going to address this to NIOSH rather than FDA.

(Colleen): Hi this is (Colleen). So we actually do, in our regulation have a requirement 

for the head suspension, and also OSHA requires that tight fitting facepieces 

such as filtering facepiece respirators be tested on the individual user prior to 

assigning that respirator to protect them. 

So particularly during the pandemic, we feel that we must focus on those 

devices that we know can achieve the fit needed and the protect - provide the 

protection expected. So we are really focusing on traditional head suspensions 

at this time.

(Michael Sterling): Okay. But ultimately isn't the criteria that something fits not how it fits?

(Colleen): Actually I'd have to provide you the reference from the regulation for the head 

suspension. I'd be happy to follow up with an e-mail to you.

(Michael Sterling): Sure, sure. Appreciate that.

(Colleen): Next question, please.

Coordinator: Thank you. Our next question I do apologize I was not able to discern the 

name if you already press Star 1 your line is now open.

(Lloyd Soong Hi this is (Lord Sunghia). So can you hear me?

(Colleen): Yes (Lord) we can hear you.
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Suzanne Schwartz: Yes we can.

(Lloyd Soong): Hi. Hi. Thank you very much. Appreciate it. Sorry I - maybe I'll speak a little 

too fast. I just have - have a question for you. Either we have the approval 

which is for general public use and that is under the NZJ and it used to be on 

the website of FDA because we need to (unintelligible) it has the approval for 

general public use surgical N95 respirator for use during public health medical 

emergencies and I think just during the pandemic.

I think sometime in March or April that would actually have thickened up and 

I had some clients who actually have stocks of this product and suddenly 

they're asking me so is this now surgical or is this N95 or is it for public use, 

you know, and so I was just trying to figure how to explain this to them 

because I don't see that the product listed.

But it is both NIOSH N95 and FDA approved. So I don't how to categorize 

this with them now even though I know is used for general public use but 

there is no more category in as far as I can see on the FDA website. So my 

question is that where is this respirator now fitting into the category?

(Liz Claverie): (Unintelligible) may I take it.

(Colleen): Yes go ahead.

(Liz Cleverly): Sure. Thank you so much. Hi (Lord) how you doing. This is (Liz Claverie).

(Lord Sunghia): I'm good what about you.

(Liz Claverie): Hi. I'm fine. Thank you.

(Liz Claverie): So (Lord) the pro code still exist the product still exists and if you have any 

further direct questions about that particular pro code and your particular 

conditions that we worked with you on you have my contact info feel free to 
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send me an e-mail and I'll try to work with you directly as relate to those 

particular submissions that have been cleared by the agency.

(Lord Sunghia): Okay. Okay, I'll do that. Thank you very much. I have a - sorry go ahead.

Heidi Sewchok: If you also have a NIOSH approval your respirator will also appear on the 

NIOSH certified equipment list. 

(Lloyd Soong): Yes it's already on the list on NIOSH just that like I mentioned before it's like 

the surgical but it's an N95 but it's very unique in the sense that it is what we 

did see that this and just so that there's no protest required but then it's not for 

occupational use or for public use. But now under this category, it doesn't 

exist anymore. So was just wondering where it falls into. So but I like what 

(Liz) said I would probably like (unintelligible).

Heidi Sewchok: Okay thank you.

Cynthia Chang: Hi this is Cynthia Chang from FDA, just to clarify there is a separate 

regulation. That product code NZJ is under the respirator for use by the 

general public and that is separate than the surgical N95 category that we're 

talking about today.

So that is a separate intended use and I can understand it can be confusing 

because there are obviously similarities but that is a separate device 

classification and that's under regulation 21 CFR 880.6260. Thank you.

Coordinator: Thank you. And our last question is from (Jordyn Ross). Your line is open

(Jordyn Ross): Hello. I have a question. It's a hypothetical question dealing with this 

(unintelligible) and product sampling. So if an entity was to purchase a 

machine from China that would later be will be subsidized for domestic 

production. Could we manufacture the first sample in China and submit it as 

the product example for NIOSH reviewer approval.
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So in short so the manufacturers submit a sample for NIOSH approval that 

was manufactured in a foreign country but the machinery that will be used for 

domestic production would be the same.

(Colleen): Hi this is (Colleen) I'm happy to answer. All right go ahead, Heidi.

Heidi Sewchok: Go ahead.

(Colleen): So as I said previously we expect it's not just about, you know, making it it's 

about how you make it and your quality control while you're making it so the 

samples that are sent to us must be made under your quality assurance system.

So in this case you're meeting your designing and developing and producing a 

device to meet the NIOSH N95 performance requirements and the additional 

FDA requirements for biocompatibility for resistance and flammability. So we 

expect those samples to be made under your system that you are documenting 

to us. Not made in China and then sent to us and everything passes and we're 

good and then you go on and make it. Okay

(Jordyn Ross): Okay so just to clarify.

Heidi Sewchok: We expect to be able to see evidence of all of those activities that (Colleen) 

just mentioned when we view your site qualification.

(Jordyn Ross): Correct so just so I completely understand if I create a quality system and 

have that implemented, you know, with a partner in China to do the first 

sample because basically the reason I'm asking is, you know, to streamline the 

process and not delay for shipment because if the machine is in China I don't 

want to have to delay NIOSH approval processes if not necessary. So...

(Colleen): Are there companies have already been in this situation and they have 

respected the integrity of the process and they've gotten the equipment and 

they've run it, it's not as easy as you think.
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You have to run it, you have to make sure you're doing an incoming 

inspection, you have to, you know, make sure you're tracking the things that 

you say you're going to check in order to produce that, you know, reliability 

that the NIOSH approved respirator users expect. And then you would say 

okay, I'm ready and you would submit to us and it's good to be in contact with 

us when you're getting into the process.

(Jordyn Ross): Correct. So my last follow up on that would be, you know, if it turns out that 

we wanted to have production entirely in China would you do a site 

qualification test in China? Or is it only limited to domestic production?

Heidi Sewchok: We would do a site qualification but you would have to consider our 

prioritization notice and take that into consideration with your timing plans.

Suzanne Schwartz: So this is Suzanne Schwartz in FDA I think that further discussion 

particular to your individual case may be best handled off-line directly with 

Colleen and her team. I see that we're at 1:00 pm and I want to take this time 

to first of all say, you know, a huge thank you to (Caileen) - Colleen. excuse 

me, and Heidi for an extremely comprehensive and informative presentation 

with respect to the updated surgical respirator guidance and asking so many 

questions with regard to the process that's been put in place. And we want to 

really recognize all of the subject matter experts who've been with us today to 

support the Q and A session.

Thank you to everybody who's tuned in. The next session is scheduled to take 

place in two weeks on Tuesday, September 15 at noon Eastern. The 

announcement of the topic will be forthcoming. Please don't hesitate to share 

with us topics of interest that you'd like to hear more about. I'd like to now 

turn the session back to Irene who will close it out.

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

participation and thoughtful questions today. Today's presentation and 

transcript will be made available on the CDRH's web page at www.FDA.gov 

/training/CDRHlearn by Wednesday, September 9.
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If you have additional questions about today's presentation, please use the 

contact information provided at the end of the slide presentation, and as 

always, we do appreciate your feedback. Following the conclusion of today's 

live webinar, please complete a short 13 question survey about your CDRH 

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The survey can be found at www.FDA.gov/CDRHwebinar immediately 

following the conclusion of today's live webinar. Again, thank you for 

participating and this concludes today's webinar.

Coordinator: Thank you for everyone's participation. This now concludes today's 

conference. All lines may disconnect at this time.

END