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Respirators for Health Care Personnel Use 

During 

the COVID-19 Pandemic

June 9, 2020
3

Dr. Jeff Shuren

Director, FDA Center for Devices 

and Radiological Health

Welcome

Dr. Stephen Hahn

Commissioner of Food and Drugs
4

 Webinar Series Objectives

 Introductions

 Terminology and Overview of Face Masks and Respirators

 FDA Emergency Use Authorizations for Respirators - UPDATE

 Strategies for Optimizing the Supply of N95 Respirators

 Policies and Authorizations for Respirator Decontamination and 

Bioburden Reduction - UPDATE

 Q&A

Agenda
5

 Share information and answer questions about safe and effective 

use of respirators during the COVID-19 emergency.

 Provide updates on important actions impacting use and 

availability of respirators.

 Provide support for external customers to help assure health care 

personnel on the front lines have the information they need and 

the supplies they need to meet demand.

Webinar Series Objectives
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 The FDA, the CDC’s National Institute for Occupational Safety and Health 

(NIOSH), and the Occupational Safety and Health Administration (OSHA) 

collaborate to assure safe use of respirators.

 The COVID-19 pandemic presents significant challenges to the availability of 

personal protective equipment (PPE), including respirators, in health care 

facilities.

 The FDA has authorized the emergency use of certain respirators and 

decontamination systems and has issued guidance on enforcement policies. 

Together these approaches provide substantial regulatory flexibility to help 

facilitate access to critical, quality medical supplies.

Background
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FDA NIOSH OSHA

Suzanne Schwartz, MD, MBA

Acting Director, Office of Strategic 

Partnerships & Technology Innovation

Center for Devices and Radiological 

Health (CDRH)

William Maisel, MD, MPH

Chief Medical Officer

Director, Office of Product Evaluation 

and Quality (OPEQ), CDRH

CAPT Elizabeth Claverie

Assistant Director, Personal Protective 

Equipment, Reprocessing & 

Disinfection Devices, OPEQ/CDRH

John Verbeten

Acting Deputy Director

Office of Enforcement and Import 

Operations

Office of Regulatory Affairs

John Howard, MD

Director, NIOSH

Maryann D’Alessandro, PhD

Director, National Personal Protective 

Technology Laboratory (NPPTL) / 

NIOSH

John Powers, BS

Branch Chief, Evaluation and Testing 

Branch, NPPTL/NIOSH

Colleen Miller, BS

Deputy Branch Chief, Conformity 

Verification and Standards 

Development Branch, NPPTL/NIOSH

Ed Fisher, MS

Biologist, Research Branch, 

NPPTL/NIOSH 

Amanda L. Edens

Deputy Assistant Secretary for 

OSHA

Andrew Levinson, MPH Deputy 

Director, OSHA Directorate of 

Standards and Guidance

Dionne Williams, DrPH, MPH 

Deputy Director, OSHA - Directorate 

of Enforcement Programs

Introductions

Overview of Organizational Responsibilities
Terminology and Overview of Respirators
9

Face Mask 

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 PPE.

N95 Respirator 

A disposable half-mask filtering facepiece respirator (FFR) 

that covers the user’s airway (nose and mouth) and offers 

protection from particulate materials at an N95 filtration 

efficiency level per 42 CFR 84.181. Generally, an N95 FFR 

used in a health care setting is regulated by the FDA under 21 

CFR 878.4040 (FDA product code MSH) and is either a class 

II device that is exempt from premarket notification or is a 

class II cleared device.

Terminology and Overview of 

Face Masks and Respirators
10

Face Shield 

A face shield is a device used to protect the 

user's eyes and face from bodily fluids, liquid 

splashes, or potentially infectious materials. 

Generally, a face shield is situated at the 

crown of the head and is constructed with 

plastic to cover the user’s eyes and face.

Surgical mask 

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 and Class I or 

Class II flammability tests, CPSC CS-191-53 

Flammability Test Method (16 CFR 1610) 

Standard for Flammability of Clothing Textiles.

Terminology and Overview of 

Face Masks and Respirators
11

Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency

 Provide regulatory flexibility while assuring products are 

appropriate for their use. 

 Enforcement Discretion as to certain FDA requirements

 In effect for the duration of the public health emergency

Face Masks and Respirators Guidance
Emergency Use Authorizations 

for Respirators
13

 EUA authority allows the 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.

 Criteria for issuance

‒ Serious or Life-Threatening Condition

‒ Evidence of Effectiveness (“May be Effective”) in diagnosing, treating, or 

preventing the serious or life-threatening disease or condition

‒ Risk-Benefit Analysis

‒ No Adequate, Approved, Available Alternatives (includes if there are 

insufficient supplies)

Emergency Use Authorization

Emergency Use Authorization of Medical Products and Related Authorities
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Emergency Use Authorizations for Respirators

 Authorizes emergency use of certain respirators for use in health care settings by 

HCP when used in accordance with CDC recommendations to prevent wearer 

exposure to pathogenic biological airborne particulates during respirator 

shortages resulting from the COVID-19 outbreak.

 Must meet certain criteria for eligibility, and follow the conditions of authorization 

and other requirements as described in the EUA

 3 Current Respirator EUAs: 

‒ NIOSH-Approved Air Purifying Respirators for Use in a Health Care 

Setting

‒ Imported Non-NIOSH-Approved Disposable Filtering Facepiece 

Respirators (updated)

‒ Non-NIOSH-Approved Disposable Filtering Facepiece Respirators 

Manufactured in China (updated)
15

Emergency Use Authorizations for Respirators

Includes:

1) Non-powered air-purifying particulate FFR and reusable respirators such as elastomeric 

half and full facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 

84 and listed on the NIOSH Certified Equipment List (CEL)

2) Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 

42 CFR Part 84, and that are listed on the NIOSH CEL

3) FFRs that were NIOSH-approved but have since passed the manufacturers’ 

recommended shelf-life, are not damaged, and have been held in accordance with 

manufacturers’ storage conditions in strategic stockpiles

4) Authorized respirators in (1) and (3) above that have been decontaminated pursuant to 

the terms and conditions of an authorized decontamination system 

NIOSH-Approved Air Purifying Respirators for Use in a Health Care Setting
16

Emergency Use Authorizations for Respirators

Includes:

1) Authorized respirators listed in Exhibit 1 of the EUA

2) Authorized respirators listed in Exhibit 1 of the EUA that do not 

have an exhalation valve and have been decontaminated pursuant 

to the terms and conditions of an authorized decontamination 

system 

The manufacturer or importer should send a request to be authorized under this EUA by email to FDA at 

CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the information requested in the EUA.

Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Updated
17

Emergency Use Authorizations for Respirators

1. Disposable FFRs that have been designed, 

evaluated, and validated to meet a given 

performance standard and have 

corresponding acceptable product 

classifications, as follows: 

2. Disposable FFRs that conform to Personal 

Protective Equipment (PPE) Directive 89/686/EEC 

(for those placed into distribution before April 21, 

2019) or that confirm to PPE regulation (European 

Union (EU) 2016/425 (for those placed into 

distribution after April 21, 2019), as evidenced by a 

CE mark, and the CE mark has been authenticated 

and verified by FDA

3. Disposable FFRs that are manufactured by entities 

that hold one or more NIOSH approvals, that have 

been verified by FDA, for FFRs, and that are 

produced by the NIOSH approval holder in 

accordance with the applicable standards of 

authorization in another country.

Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Filtering Facepiece Respirators (FFR) meeting at least one of the criteria in the following 

three categories are authorized under this EUA (updated):
18

Emergency Use Authorizations for Respirators

A disposable non-NIOSH-approved respirator manufactured in China is authorized under this EUA if it meets any of 

the following criteria (updated):

1) The respirator is manufactured by an entity that holds one or more NIOSH approvals, that have been verified by FDA, for 

FFRs, and that are produced by the NIOSH approval holder in accordance with applicable standards of authorization in 

another country.

2) The respirator: a) Has a registration certification, reflecting regulatory authorization, under the jurisdiction of the Chinese 

National Medical Products Administration (NMPA) and that is given by an appropriate provincial or municipal authority, and 

that has been authenticated and verified by FDA, or b) Conforms to the Personal Protective Equipment (PPE) Directive 

89/686/EEC (for those placed into distribution before April 21, 2019) or that conforms to PPE Regulation (European Union 

(EU) 2016/425 (for those placed into distribution after April 21, 2019), as evidenced by a CE Mark, and the CE mark has 

been authenticated and verified by FDA.

3) The respirator was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator 

because it demonstrated acceptable performance to applicable standards as documented by test reports, has had 

particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) 

TEB-APR-STP-0059 within 45 calendar days of the date of issuance of the May 7, 2020 letter, and has results of NIOSH 

testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. 

A respirator authorized under this EUA because it meets the above criteria (3), is no longer authorized if it has been sampled 

by FDA, tested by NIOSH via a modified version of STP TEB-APR-STP-0059, and results according to NIOSH that 

indicates one or more of the 30 sampled respirators has a filtration efficiency of less than 95%.

Non-NIOSH-Approved Disposable Filtering Facepiece Respirators 

Manufactured in China
19

Summary of 

Emergency Use Authorizations for Respirators

 3 Current Respirator EUAs: 

‒ NIOSH-Approved Air Purifying Respirators for Use in a Health 

Care Setting

‒ Imported Non-NIOSH-Approved Disposable Filtering Facepiece 

Respirators (see Exhibit 1)

‒ Non-NIOSH-Approved Disposable Filtering Facepiece Respirators 

Manufactured in China (see Appendix A)
Strategies for Optimizing the 

Supply of N95 Respirators
21

 Review CDC recommendations Strategies for Optimizing the Supply of N95 Respirators

which includes Conventional Capacity, Contingency Capacity and Crisis Capacity 

strategies.

 FDA-cleared or NIOSH-approved N95 respirators should be used when they are available.

 When they are not available, FDA recommends using FDA-authorized respirators before 

any other alternatives.

 FDA does 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.

 HCP should ensure that respirators fit adequately before every use.

 It may be difficult to achieve an adequate fit with respirators that have ear loops instead of 

head straps.

Strategies for Optimizing the Supply of 

N95 Respirators

Enforcement Policy for Face Masks and Respirators Guidance (Revised)
Policies and Authorizations for Respirator 

Decontamination and Bioburden Reduction
23

 Evidence-Based Approach to Decontamination and Bioburden 

Reduction

 Overview of Tiered Approach for Decontamination and Bioburden 

Reduction Systems

 Recommended Content of Pre-EUA submissions and EUA requests

Decontamination and Bioburden Reduction

Recommendations for Sponsors Requesting EUAs for Decontamination and 

Bioburden Reduction Systems for Surgical Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency
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 Hierarchy applicable to most established microbicidal processes

 Tiered approach for processes that follow hierarchy

 Recommend discussion with FDA for processes that do not follow this 

hierarchy (CDRH-COVID19-SurgicalMasks@fda.hhs.gov)

Evidence-Based Approach to 

Decontamination and Bioburden Reduction 

Descending Order 

of Resistance 

of Microorganisms to 

Germicidal Chemicals
25

Tiered Approach for 

Decontamination and Bioburden Reduction Systems 

TIER Name Intended Use Recommended Evidence of Decontamination

Tier 1 Decontamination of Surgical 

Masks and/or Respirators for 

Single- or Multiple-Users *

Multiple-Users or 

Single-Users

‒ > 6-log spore reduction of the most resistant 

spore for the proposed process OR

‒ > 6-log reduction of Mycobacterium species 

(e.g. M. terrae or M. abscesses

Tier 2 Decontamination of Surgical 

Masks and/or Respirators for 

Single-Users Only

Single-User ‒ > 6-log reduction of 3 non-enveloped viruses OR

‒ > 6-log reduction of two gram-positive and two 

gram-negative vegetative bacteria

Tier 3 Bioburden Reduction of N95 

Respirators for Single-Users 

Only to Supplement CDC 

Reuse Recommendations

Single-User Only to 

Supplement 

Existing CDC Reuse 

Recommendations

‒ > 3-log reduction of non-enveloped virus OR

‒ > 3-log reduction of two gram-positive and two 

gram-negative vegetative bacteria OR

‒ other evidence demonstrating similar effect

*Applies to respirators that are non-cellulose and compatible for decontamination
26

Requests should include:

1. Proposed Intended Use

2. Description of the Technology

3. Description of the Process 

Controls including Critical Cycle 

Parameters

4. Validation of Decontamination or 

Bioburden Reduction (Tiered 

Approach)

5. Material and Respirator 

Compatibility

6. Process Residues

7. Number of Decontamination/ 

Bioburden Reduction Cycles

 Filtration performance

 Breathability

 Fit test data

8. Chain of Custody and Safeguards 

to Prevent Inadvertent Exposure

9. Labeling

Recommended Content of 

Pre-EUA Submissions and EUA Requests
27

 Authorized for compatible N95 respirators (must meet all criteria):

‒ Non-cellulose respirators AND

‒ Without an exhalation valve AND

‒ Either: 1) authorized in the NIOSH-Approved Air Purifying Respirator 

EUA, OR 2) authorized and identified in Exhibit 1 of the EUA for 

Imported, Non-NIOSH Approved Disposable Filtering Facepiece 

Respirators

 Only when there are insufficient supplies of Filtering Facepiece Respirators 

(FFRs) resulting from the COVID-19 pandemic

EUAs for Decontamination and Bioburden 

Reduction Systems

Emergency Use Authorizations
28

 Battelle Decontamination System

 STERIS Sterilization Systems for Decontamination of N95 Respirators

 Advanced Sterilization Products (ASP) STERRAD Sterilization System

 Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle

 Sterilucent, Inc. Sterilization System

 Duke Decontamination System

 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers

 Stryker Sustainability Solutions VHP Decontamination System

EUAs for Decontamination and Bioburden 

Reduction Systems

Emergency Use Authorizations
29

Questions?

CDRH-COVID19-SurgicalMasks@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Sub-heading: 

Personal Protective Equipment (PPE)”

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