Contains Nonbinding Recommendations

Enforcement Policy for Face Masks

and Respirators During the
Coronavirus Disease (COVID-19)
Public Health Emergency (Revised)
Guidance for Industry and
Food and Drug Administration Staff
May 2020

This document supersedes “Enforcement Policy for Face Masks and Respirators
During the Coronavirus Disease (COVID-19) Public Health Emergency
(Revised)” issued April 2020.

U.S. Department of Health and Human Services

Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Office of Product Evaluation and Quality (OPEQ)
 Contains Nonbinding Recommendations

Preface
Public Comment
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public
health emergency. This guidance is being implemented without prior public comment because
the Food and Drug Administration (FDA or the Agency) has determined that prior public
participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency’s good guidance practices.

Comments may be submitted at any time for Agency consideration. Submit written comments to
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
All comments should be identified with the docket number FDA-2020-D-1138 and complete
title of the guidance in the request.

Additional Copies
Additional copies are available from the FDA webpage titled “Coronavirus Disease 2019
(COVID-19),” available at https://www.fda.gov/emergency-preparedness-and-response/mcm-
issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, and the
FDA webpage titled “Search for FDA Guidance Documents,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. You may also send
an e-mail request to [email protected] to receive an additional copy of the
guidance. Please include the document number 20018 and complete title of the guidance in the
request.

Questions
For questions about this document, contact 1-888-INFO-FDA or CDRH-COVID19-
[email protected]
 Contains Nonbinding Recommendations

Table of Contents
I. Introduction ......................................................................................................................... 1
II. Background ......................................................................................................................... 2
III. Scope .................................................................................................................................. 3
IV. Definitions ........................................................................................................................... 4
V. Policy .................................................................................................................................. 5
A. Overview....................................................................................................................... 5
B. Face Masks, Face Shields, and N95 Respirators Not Intended for a Medical Purpose ....... 5
C. Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid
Barrier Protection .......................................................................................................... 6
D. Face Shields Intended for a Medical Purpose .................................................................. 7
E. Surgical Masks Intended to Provide Liquid Barrier Protection ......................................... 8
F. Alternatives When FDA-Cleared or NIOSH-Approved N95 Respirators are Not Available
..................................................................................................................................... 9
VI. EUAs for Face Masks Intended for a Medical Purpose, Surgical Masks and N95 Respirators 10
 Contains Nonbinding Recommendations

Enforcement Policy for Face Masks

and Respirators During the
Coronavirus Disease (COVID-19)
Public Health Emergency (Revised)
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.

I. Introduction
FDA plays a critical role in protecting the United States from threats such as emerging infectious
diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to
providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability of general use face
masks for the general public and particulate filtering facepiece respirators (including N95 respirators)
for healthcare personnel (HCP) 1 for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency

1
As used in the three EUAs for filtering facepiece respirators in effect at the time of this guidance, healthcare personnel
(HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect
exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids);
contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air.
These healthcare personnel include, but are not limited to, emergency medical service personnel, nurses, nursing
assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and
trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but
who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary,
environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer
personnel).

1
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related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31,
2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance
with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March
25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease
2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this
guidance is being implemented without prior public comment because FDA has determined that prior
public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to
comment in accordance with the Agency’s good guidance practices.

In general, FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that something is
suggested or recommended, but not required.

II. Background
There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has
been named “SARS-CoV-2,” and the disease it causes has been named “Coronavirus Disease
2019” (COVID-19). On January 31, 2020, the HHS issued a declaration of a public health
emergency related to COVID-19 and mobilized the Operating Divisions of HHS. 2 In addition, on
March 13, 2020, the President declared a national emergency in response to COVID-19. 3

FDA believes the policy set forth in this guidance may help address these urgent public health
concerns by clarifying the regulatory landscape of face masks and respirators, helping to expand the
availability of general use face masks for use by the general public, and of filtering facepiece
respirators (including N95 respirators) for use by HCP in healthcare settings.

This document supersedes the guidance, “Enforcement Policy for Face Masks and Respirators
During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” issued April
2020. The April 2020 version revised the original guidance, “Enforcement Policy for Face Masks
and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency,” issued
March 25, 2020, to include face shields and to provide FDA’s recommendations regarding
alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available. This version
includes additional updates regarding alternatives when FDA-cleared or NIOSH-approved N95
respirators are not available and removes FDA’s prior recommendations regarding emergency use
2
Secretary of Health and Human Services Alex M Azar, Determination that a Public Health Emergency Exists. (Jan. 31,
2020, renewed April 21, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
3
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
(Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-
emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

2
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authorizations (EUAs) for decontamination of face masks and filtering facepiece respirators. 4

III. Scope
There are many products marketed in the United States as “face masks” that offer a range of
protection against potential health hazards. Face masks 5 and respirators are regulated by FDA when
they meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act). Generally, face masks fall within this definition when they are intended for a
medical purpose, including for use by HCP. 6 Face masks that are not intended for a medical purpose
are not medical devices, as described in further detail below. FDA-regulated face masks and
respirators are listed in Table 1:

Table 1
Classification Device Type Product
Regulation Code 7
Mask, Surgical FXX
Pediatric/Child Facemask OXZ
Accessory, Surgical Apparel (Face Shield) 8 LYU
21 CFR 878.4040
Surgical mask with antimicrobial/antiviral agent OUK
Respirator, Surgical MSH
N95 Respirator with Antimicrobial/Antiviral Agent ONT
N95 Respirator with Antimicrobial/Antiviral Agent for Use ORW
21 CFR 880.6260 by the General Public in Public Health Medical
Emergencies
Respirator, N95, for Use by the General Public in Public NZJ
21 CFR 880.6260
Health Medical Emergencies

4
Concurrently with issuance of this revised guidance, the FDA is issuing the guidance, “Recommendations for Sponsors
Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
5
FDA also considers face mask and surgical mask accessories that are intended to help hold the mask to the face (e.g.,
surgical mask strap holders, tension release bands) to fall within the scope of this guidance. Respirator accessories are not
included in the scope of this guidance.
6
As used in this guidance “intended for a medical purpose” means that the device is intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease and, therefore, meets the
definition of “device” set forth in section 201(h) of the FD&C Act.
7
For more information see the Product Classification Database at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
8
The scope of this guidance is limited to face shields and their accessories that are intended to help to hold the face shield
to the face under product code LYU, “Accessory, Surgical Apparel.” Face shields and their accessories that are intended
to help to hold the face shield to the face are class I devices and are exempt from premarket notification requirements
under 510(k) of the FD&C Act. See 21 CFR 878.4040. Face shields combined with devices other than a face mask (e.g.,
a gown, hood or toga) are not within the scope of this guidance. See “Enforcement Policy for Gowns, Other Apparel, and
Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-
and-gloves-during-coronavirus-disease-covid-19-public-health.

3
 Contains Nonbinding Recommendations

This policy does NOT apply to other types of masks including but not limited to those in Table 2.

Table 2
Classification Device Type Product
Regulation Code
21 CFR 868.5450 Humidifier, Respiratory Mask OBN
Humidifier, Respiratory Gas BTT
21 CFR 868.5550 Mask, Anesthetic, Gas BSJ
21 CFR 868.5580 Mask, Oxygen BYG
21 CFR 868.5600 Mask, Oxygen, Low Concentration, Venturi BYG
21 CFR 868.5570 Mask, Oxygen, Non-Rebreathing KGB
Resuscitator, Manual, Non Self-Inflating NHK
21 CFR 868.5905
Mask, Ventilator, Non-Continuous, Reprocessed NMC
21 CFR 868.5560 Strap, Head, Gas Mask BTK

FDA recognizes that, when personal protective equipment (PPE), such as FDA-cleared surgical
masks or respirators, are unavailable, individuals, including HCP, might improvise. FDA does not
intend to object to individuals’ distribution and use of improvised PPE when FDA-cleared or
authorized surgical masks or respirators are not available.

IV. Definitions
For the purposes of this guidance, the following definitions are used.

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 for use by the general
public and HCP only as source control in accordance with CDC recommendations. 9, 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. 11

Filtering Facepiece Respirator – A filtering facepiece respirator (FFR) is a device that is a

disposable half-face-piece non-powered air-purifying particulate respirator intended for use to cover
the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne
particulates.

9
Source control refers to the use of a facemask or cloth face covering over the mouth and nose to contain that
individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have
symptoms of COVID-19.
10
https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
11
CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability of Clothing Textiles.

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 Contains Nonbinding Recommendations

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. Such an N95 FFR used in a healthcare setting is regulated by
FDA under 21 CFR 878.4040 (FDA product code MSH) and is either a class II device that is exempt
from premarket notification requirements under section 510(k) of the FD&C Act or is a class II
cleared device.

NIOSH Approved N95 Respirator – An N95 respirator, approved by NIOSH that meets filtration
efficiency level per 42 CFR 84.181.

Surgical N95 Respirator – A disposable FFR used in a healthcare setting that is worn by HCP
during procedures to protect both the patient and HCP from the transfer of microorganisms, body
fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181. A surgical
N95 respirator is regulated by FDA under 21 CFR 878.4040 (FDA product code MSH) and is either
a class II device that is exempt from premarket notification requirements under section 510(k) of the
FD&C Act or is a class II cleared device.

V. Policy
A. Overview
FDA is taking steps to expand the availability of face masks and respirators and believes the policy
set forth in this guidance may help address the urgent public health concerns caused by shortages of
such products by taking a risk-based approach and clarifying the policies that FDA intends to apply
to masks and respirators, including these products’ associated indications and claims.

B. Face Masks, Face Shields, and N95 Respirators Not Intended

for a Medical Purpose
Face masks, face shields, and N95 respirators are devices when they meet the definition of a device
set forth in section 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products
are devices when they are intended for use in the diagnosis of disease or other conditions or in the
cure, mitigation, treatment, or prevention of disease.

Other face masks, face shields, and FFRs are marketed to the general public for general, non-medical
purposes, such as use in construction and other industrial applications. Because they are not intended
for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or
prevention of disease, FDA device marketing authorization is not required, and all the other
requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these
products.

Face masks, face shields, and respirators are devices when they are intended for a medical purpose,
such as prevention of infectious disease transmission (including uses related to COVID-19). Face
masks, face shields, and respirators are not devices when they are intended for a non-medical

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purpose, such as for use in construction. When evaluating whether these products are intended for a
medical purpose, among other considerations, FDA will consider whether:

1) they are labeled or otherwise intended for use by a HCP;

2) they are labeled or otherwise for use in a health care facility or environment; and
3) they include any drugs, biologics, or anti-microbial/anti-viral agents.

C. Face Masks Intended for a Medical Purpose that are NOT

Intended to Provide Liquid Barrier Protection
In general, FDA recommends that HCP follow current Centers for Disease Control and Prevention
(CDC) guidance regarding personal protective equipment (PPE) that should be used during the
COVID-19 outbreak. 12 Health care employers must also comply with standards of the Occupational
Safety and Health Administration (OSHA) that require PPE to protect workers and that apply to
infectious disease hazards. 13 Face masks are to be used for source control only, and are not personal
protective equipment, meaning they are not a substitute for FFRs or for surgical face masks. 14

In the April 2, 2020 publication of this guidance, FDA provided flexibility regarding distribution and
use of face masks without compliance with certain regulatory requirements, including submission of
a 510(k) under certain circumstances. FDA’s policy was based on the evolving public health
emergency and the increased need for devices for source control. In addition to this policy and in
response to the shortage of face masks, on April 18, 2020 FDA issued an EUA for certain face
masks 15 that FDA determined met the criteria for issuance under Section 564 of the Act. This EUA
has succeeded in increasing the availability of face masks for HCP and the general public for use as
source control when FDA-cleared face masks are not available.

Wherever possible, HCP and the general public should continue to use FDA-cleared face masks as
source control or, when those are not available, face masks authorized under the EUA. However, to
help foster the availability of equipment that might offer some benefit to HCP and the general public
during the COVID-19 outbreak, FDA is continuing its April 2, 2020 policy regarding face masks,
recognizing there is some overlap with the EUA. Thus, for the duration of the public health
emergency FDA does not intend to object to the distribution and use of face masks, with or without a
face shield (not including respirators), that are intended for a medical purpose (whether used by
medical personnel or the general public), without compliance with the following regulatory
requirements where the face mask does not create an undue risk in light of the public health
emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and
21 CFR 807.81, Registration and Listing requirements in 21 CFR 807, Quality System Regulation
requirements in 21 CFR 820, Reports of Corrections and Removals in 21 CFR Part 806, and Unique

12
https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-
recommendations.html?CDC_AA_refVal=https%3A%2F%2Ffanyv88.com%3A443%2Fhttps%2Fwww.cdc.gov%2Fcoronavirus%2F2019-
ncov%2Fhcp%2Finfection-control.html.
13
See 29 CFR 1910 subpart I.
14
See FDA’s EUA for face masks (non-surgical) available at https://www.fda.gov/media/137121/download and FAQs on
the Emergency Use Authorization for Face Masks (Non-Surgical) available at https://www.fda.gov/medical-
devices/emergency-situations-medical-devices/faqs-emergency-use-authorization-face-masks-non-surgical.
15
https://www.fda.gov/media/137121/download.

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 Contains Nonbinding Recommendations

Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes
such devices would not create such an undue risk where:

• The product includes labeling that accurately describes the product as a face mask (as
opposed to a surgical mask or FFR) and includes a list of the body contacting materials
(which does not include any drugs or biologics);

• The product includes labeling that makes recommendations that would reduce sufficiently the
risk of use, for example, recommendations against: use in any surgical setting or where
significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a
clinical setting where the infection risk level through inhalation exposure is high; and use in
the presence of a high intensity heat source or flammable gas; and

• The product is not intended for any use that would create an undue risk in light of the public
health emergency, for example the labeling does not include uses for antimicrobial or
antiviral protection or related uses or uses for infection prevention or reduction or related uses
and does not include particulate filtration claims.

D. Face Shields Intended for a Medical Purpose

In general, FDA recommends that HCP follow current Centers for Disease Control and Prevention
(CDC) guidance regarding PPE that should be used during the COVID-19 outbreak. 16 Health care
employers must also comply with standards of the Occupational Safety and Health Administration
(OSHA) that require PPE to protect workers and that apply to infectious disease hazards. 17 To help
foster the availability of equipment that might offer some benefit to HCP and the general public
during the COVID-19 outbreak, for the duration of the public health emergency, FDA does not
intend to object to the distribution and use of face shields that are intended for a medical purpose
(whether used by medical personnel or the general public), without compliance with the following
regulatory requirements where the face shield does not create an undue risk in light of the public
health emergency: Registration and Listing requirements in 21 CFR 807, Quality System Regulation
requirements in 21 CFR Part 820, Reports of Corrections and Removals in 21 CFR Part 806, and
Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently
believes such devices would not create such an undue risk where:

• The product includes labeling that accurately describes the product as a face shield and
includes a list of the body contacting materials (which does not include any drugs, or
biologics);

• The face shield does not contain any materials that will cause flammability, or the product
meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a
recommendation against use in the presence of high intensity heat source or flammable gas);

16
https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-
recommendations.html?CDC_AA_refVal=https%3A%2F%2Ffanyv88.com%3A443%2Fhttps%2Fwww.cdc.gov%2Fcoronavirus%2F2019-
ncov%2Fhcp%2Finfection-control.html.
17
See 29 CFR 1910 subpart I.

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• The product is not intended for any use that would create an undue risk in light of the public
health emergency, for example, the labeling does not include uses for antimicrobial or
antiviral protection or related uses or uses for infection prevention or reduction or related
uses, or for radiation protection.

E. Surgical Masks Intended to Provide Liquid Barrier Protection

Surgical masks are class II devices that cover the user’s nose and mouth and provide a physical
barrier to fluids and particulate materials and are tested for flammability and biocompatibility. For
the duration of the declared public health emergency, FDA does not intend to object to the
distribution and use of surgical masks without compliance with the following regulatory
requirements where the surgical mask does not create an undue risk in light of the public health
emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and
21 CFR 807.81, Registration and Listing requirements in 21 CFR 807, Quality System Regulation
requirements in 21 CFR 820, Reports of Corrections and Removals in 21 CFR Part 806, and Unique
Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes
such devices would not create such an undue risk where:

• The product meets fluid resistance testing (liquid barrier performance) consistent with
standard ASTM F1862 18 Standard Test Method for Resistance of Medical Face Masks to
Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known
Velocity);

• The product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless
labeled with a recommendation against use in the presence of high intensity heat source or
flammable gas);

• The product includes labeling that accurately describes the product as a surgical mask and
includes a list of the body contacting materials (which does not include any drugs or
biologics); and

• The product is not intended for any use that would create an undue risk in light of the
public health emergency, for example, the labeling does not include uses for antimicrobial
or antiviral protection or related uses or uses for infection prevention or reduction or
related uses and does not include particulate filtration claims.

18 For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized
Consensus Standards Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
For more information regarding use of consensus standards in regulatory submissions, refer to FDA guidance titled
“Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices.

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F. Alternatives When FDA-Cleared or NIOSH-Approved N95

Respirators are Not Available
CDC published on its website Strategies for Optimizing the Supply of N95 Respirators:
Crisis/Alternate Strategies,19 which, as part of a set of crisis management recommendations,
identifies alternatives to FDA-cleared or NIOSH-approved N95 respirators approved under
standards used in other countries, some of which were evaluated under methods that are similar to
NIOSH-approved N95 respirators.

In the April 2, 2020 publication of this guidance, FDA provided flexibility regarding distribution
and use of respirators identified in the CDC recommendations without compliance with certain
regulatory requirements, including submission of a 510(k) under certain circumstances. FDA’s
policy was based on the evolving public health emergency and the increasing need for respiratory
protection devices for HCP, which was rapidly outpacing the supply of FDA-cleared or NIOSH-
approved respirators. The guidance also recommended that importers take appropriate steps to
verify the authenticity of products they import.

In addition to this policy and in response to the shortage of respirators, FDA issued emergency use
authorizations (EUAs) for certain respirators that FDA determined met the criteria for issuance
under Section 564 of the Act. 20 These EUAs have succeeded in increasing the availability of
respirators for HCP when FDA-cleared or NIOSH-approved respirators are not available.

Since the April 2, 2020 publication of this guidance, FDA has become aware of concerns regarding
the performance of certain respirators based on testing conducted by the CDC. 21 This indicates that
greater FDA oversight of respirators that are not FDA-cleared or authorized under an EUA is
important to protect the public health. As a result of these changed circumstances, FDA is
discontinuing its previous policy from April 2, 2020 under which FDA did not intend to object to
the distribution and use of certain respirators that were not FDA-cleared or authorized under an
EUA and did not meet other regulatory requirements.

FDA currently believes that FDA-cleared or NIOSH-approved N95 respirators should be used
when they are available, but when they are not, FDA recommends using FDA-authorized
respirators before any other alternatives. This is consistent with the CDC’s approach for optimizing
the supply of N95 respirators. FDA does not recommend using a product as a respirator unless it
has 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 by the general public and HCP as source
control when certain criteria are met under the EUA for face masks. 22 In that case, the product
should be labeled accordingly and not used as a respirator. 23
19
https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html.
20
See FDA’s webpage regarding emergency use authorizations, available at https://www.fda.gov/medical-
devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe.
21
https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html.
22
https://www.fda.gov/media/137121/download.
23
Source control refers to the use of a facemask or cloth face covering over the mouth and nose to contain that
individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have
symptoms of COVID-19. See also https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-
recommendations.html.

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In addition, FDA notes that HCP should ensure that respirators adequately fit. Hospitals and end
users should be aware that it may be difficult to achieve an adequate fit when wearing respirators
with ear loops instead of head straps. When proper fit is not achieved for a respirator, it should not
be used as a respiratory protective device.

VI. EUAs for Face Masks Intended for a Medical Purpose,

Surgical Masks and N95 Respirators
Wherever possible, health care facilities should continue to use FDA-cleared surgical masks and
NIOSH-approved and/or FDA-cleared N95 respirators, or better. In response to the COVID-19
pandemic, FDA has also issued EUAs that authorize certain FFRs, including NIOSH-approved
FFRs,24 imported non-NIOSH-approved disposable FFRs from certain jurisdictions excluding
China,25 and non-NIOSH-approved disposable FFRs manufactured in China,26 for use in healthcare
settings by HCP. These EUAs are intended to help increase availability of these devices to front-line
personnel during the public health emergency. FDA has also issued an EUA for face masks 27 for use
by the general public and HCP as source control.

For devices that do not fall within the scope of these EUAs, FDA is interested in interacting with
manufacturers on additional device-specific EUAs. This may include manufacturers of masks and
respirators that are not currently legally marketed in the US as well as manufacturers who have not
previously manufactured masks or respirators with capabilities to increase supply of these devices.

FDA would find it helpful if such manufacturers (whether foreign or domestic) send FDA the
following information to [email protected]; FDA believes this
information will be valuable in assessing whether the device would be able to meet the EUA
requirements. FDA believes that companies may already have available information to help support
an EUA request such as the information outlined below. FDA will expeditiously review this
information, and other required information,28 to determine whether the device can be authorized
under an EUA.

1) For current face mask and respirator manufacturers whose product(s) are not currently
marketed in the US, FDA recommends providing the following information:
a. General information such as your contact information, name and place of business,
email address, and contact information for a U.S. agent (if any) in addition to general
information about the device such as the proprietary or brand name, model number,
and marketing authorization in your country (or region).
b. A copy of the product labeling.
c. Whether the device currently has marketing authorization in another regulatory
jurisdiction (including certification number, if available).

24
https://www.fda.gov/media/135763/download.
25
https://www.fda.gov/media/136403/download.
26
https://www.fda.gov/media/136664/download.
27
https://www.fda.gov/media/137121/download.
28
See Section 564 of the FD&C Act.

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d. Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO
13485: Medical Devices – Quality Management Systems – Requirements for
Regulatory Purposes or an equivalent quality system and the manufacturer or
importer has documentation of such.
e. Description of testing conducted on the device, including any standards met, such as
liquid barrier protection, flammability, biocompatibility, and filtration performance, as
appropriate. For surgical N95 respirators, FDA recommends including fluid resistance
testing (liquid barrier performance).

2) For face mask manufacturers who have not previously been engaged in medical device
manufacturing but with capabilities to increase supply of these devices:

FDA welcomes the opportunity to work with manufacturers not previously engaged in
medical device manufacturing with the interest and capability to manufacture face masks and
respirators. This may include US manufacturers in other manufacturing sectors. These
manufacturers should send an email to the address above and describe their proposed
approach. FDA intends to work collaboratively with these manufacturers through its EUA
process.

For any face mask or FFR (including N95 respirators) issued an EUA, FDA will include appropriate
conditions of authorization in accordance with section 564 of the FD&C Act. Although this is a case-
by-case determination, based on current information and experience, we will likely include the
following conditions:

• Appropriate conditions designed to ensure that HCP administering the device are
informed—
o that FDA has authorized the emergency use of the device;
o of the significant known and potential benefits and risks of the emergency use of
the device, and of the extent to which such benefit and risks are unknown; and
o of the alternatives to the device that are available, and of their benefits and risks.

• Appropriate conditions designed to ensure that individuals to whom the device is

administered are informed—
o that FDA has authorized the emergency use of the device;
o of the significant known and potential benefits and risks of the emergency use of
the device, and of the extent to which such benefit and risks are unknown; and
o of the option to accept or refuse administration of the device, of the consequence,
if any, of refusing administration of the device, and of the alternatives to the
device that are available and of their benefits and risks.

• Appropriate conditions for the monitoring and reporting of adverse events associated with
the emergency use of the device. FDA intends to include conditions that are consistent
with those promulgated under 21 CFR Part 803.

• For manufacturers of the device, appropriate conditions concerning recordkeeping and

reporting, including records access by FDA, with respect to emergency use of the device.

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