Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Enforcement Policy for Face Masks
and Barrier Face Coverings for
Coronavirus Disease (COVID-19)
Response
Guidance for Industry and
Food and Drug Administration Staff
Document issued on September 5, 2023
This document supersedes “Enforcement Policy for Face Masks and Barrier
Face Coverings During the Coronavirus Disease (COVID-19) Public Health
Emergency” issued March 2023.
For questions about this document, contact 1-888-INFO-FDA or CDRH-COVID19-
SurgicalMasks@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2020-D-1138. Comments may not be
acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
20018 and complete title of the guidance in the request.

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 Not Intended for a Medical Purpose ................................................................ 5
C. Face Masks and Barrier Face Coverings Intended for a Medical Purpose that are NOT
Intended to Provide Liquid Barrier Protection ..................................................................... 5
VI. EUAs for Face Masks Intended for a Medical Purpose .............................................................. 8

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Enforcement Policy for Face Masks
and Barrier Face Coverings for
Coronavirus Disease (COVID-19)
Response
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.
This policy is intended to remain in effect only for the duration of the declaration under section 564
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Secretary of Health and Human
Services (HHS) on March 24, 2020 that circumstances exist justifying the authorization of
emergency use of devices, including alternative products used as devices (85 FR 17335).1 This policy
is intended to remain in effect for the duration of that declaration, unless FDA revises or replaces this
guidance.
For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see
the FDA Recognized Consensus Standards Database.2
In general, FDA’s guidance documents 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
1 Available at https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-
declaration.
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

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should in Agency guidances means that something is suggested or recommended, but not required.
II. Background
In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. 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, HHS issued a declaration of a public health emergency
related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13,
2020, the President declared a national emergency in response to COVID-19.4
The policy set forth in this guidance was intended to help address these urgent public health concerns
by clarifying the regulatory landscape of face masks and barrier face coverings and helping to
expand the availability of these devices for use by the general public and healthcare personnel
(HCP)5 in healthcare settings, as appropriate.
This document supersedes the guidance, “Enforcement Policy for Face Masks and Barrier Face
Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),”
issued March 2023. The March 2023 version of the guidance had split the previous version of the
guidance, "Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical
Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
(Revised),” into two separate guidance documents. This bifurcation of the earlier version contained
identical policies to the corresponding parts of the September 2021 version and did not affect the
policy. Rather, it was intended only to facilitate a different timeline and process for transitioning
back to normal operations for specific device types. For more information, see the March 13, 2023
Federal Register notice entitled “Guidance Documents Related to Coronavirus Disease 2019
(COVID-19).”6
3 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued on
Jan. 31, 2020, subsequently renewed, and expired on May 11, 2023), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
(Mar. 13, 2020), available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-
national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there was a
Presidential Declaration continuing the national emergency concerning the COVID-19 pandemic beyond March 1, 2021.
See Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic
(February 24, 2021), available at https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-
the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
5 For purposes 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).
6 See “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)” (88 FR 15417), available at
https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirusdisease-
2019-covid-19.

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The September 2021 version revised the guidance “Enforcement Policy for Face Masks and
Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),”
issued May 2020 to further add a policy that, during the public health emergency, FDA generally
does not intend to object to stockpiled, non- National Institute for Occupational Safety and Health
(NIOSH)-approved disposable filtering facepiece respirators (FFRs) being further distributed and
used as face masks for source control (as opposed to use as FFRs for respiratory protection) by the
general public and HCP where such use does not create an undue risk in light of the public health
emergency. The May 2020 version revised the guidance, “Enforcement Policy for Face Masks and
Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)”
issued April 2020, to include recommendations about alternatives when FDA-cleared or NIOSH-
approved N95 respirators are not available and to remove FDA’s prior recommendations regarding
emergency use authorizations (EUAs) for decontamination of face masks and FFRs. 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. The September 2021 version included barrier
face coverings intended for a medical purpose but not intended to provide liquid barrier protection
within the scope of this guidance, and provided FDA’s recommendations regarding submicron
particulate filtration efficiency, airflow resistance, and leakage assessments for these devices, as well
as labeling recommendations, as described in ASTM F3502: Standard Specification for Barrier Face
Coverings. Additionally, the September 2021 revision removed reference to use of alternatives when
FDA-cleared or NIOSH-approved N95 respirators are not available based on current Centers for
Disease Control and Prevention (CDC) and FDA recommendations that healthcare facilities should
not be using crisis capacity strategies at the time of issuance of this guidance.7 Consistent with the
March 13, 2023 Federal Register notice,8 the current guidance has been revised to align with the
duration of the relevant declaration supporting authorization of emergency use under section 564 of
the FD&C Act.
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 masks9 and barrier face coverings are regulated by
FDA when they meet the definition of a device under section 201(h)(1) of the FD&C Act. Generally,
face masks and barrier face coverings fall within this definition when they are intended for a medical
purpose, including for use by HCP.10 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 barrier face
coverings subject to this guidance are listed in table 1:
7 https://www.fda.gov/news-events/press-announcements/fda-brief-fda-revokes-emergency-use-authorizations-certain-
respirators-and-decontamination-systems
8 See footnote 6.
9 FDA also considers face mask accessories that are intended to help hold the mask to the face (e.g., strap holders, tension
release bands) to fall within the scope of this guidance.
10 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)(1) of the FD&C Act.

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Table 1
Classification
Regulation
Device Type Product
Code11
Not classified
Face Mask Within the Scope of the Face Mask and Barrier
Face Covering Enforcement Policy or Face Mask Umbrella
EUA
QKR12
Not classified Barrier Face Covering Within the Scope of the Face Mask
and Barrier Face Covering Enforcement Policy
QOZ13
This policy does NOT apply to other types of masks including but not limited to those in Table 2.
Table 2
Classification
Regulation
Device Type Product
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
21 CFR 868.5905 Resuscitator, Manual, Non Self-Inflating NHK
Mask, Ventilator, Non-Continuous, Reprocessed NMC
21 CFR 868.5560 Strap, Head, Gas Mask BTK
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 as source control in accordance with CDC recommendations.14
Barrier Face Covering – As described in the ASTM F3502 standard, a barrier face covering is a
product worn on the face, specifically covering at least the wearer’s nose and mouth, with the
11 For more information see the Product Classification Database at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
12 This product code was created for face masks described in Section IV of this guidance. Face masks that are authorized
by the Face Mask Umbrella EUA may also use this product code. This product code did not exist prior to the COVID-19
pandemic.
13 This product code has been created to describe barrier face coverings, as described in Section IV of this guidance. This
product code did not exist prior to the COVID-19 pandemic.
14 Source control refers to the use of a face mask or barrier 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 an infectious disease. See also https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-
recommendations.html.

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primary purpose of providing source control and to provide a degree of particulate filtration to reduce
the amount of inhaled particulate matter.
V. Policy
A. Overview
In response to the COVID-19 pandemic, FDA has taken steps to expand the availability of face
masks and barrier face coverings. The policy set forth in this guidance was intended to 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 these products, including their
associated indications and claims.
B. Face Masks Not Intended for a Medical Purpose
Face masks are devices when they meet the definition of a device set forth in section 201(h)(1) of the
FD&C Act. Under section 201(h)(1) 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 are marketed to workplaces and 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 are devices when they are intended for a medical purpose, such as prevention of
infectious disease transmission. Face masks are not devices when they are intended for a non-
medical 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 HCP;
2) they are labeled or otherwise for use in a healthcare facility or environment; and
3) they include any drugs, biologics, or anti-microbial/anti-viral agents.
C. Face Masks and Barrier Face Coverings Intended for a
Medical Purpose that are NOT Intended to Provide Liquid
Barrier Protection
In general, FDA recommends that HCP follow current CDC guidance regarding use of personal
protective equipment (PPE) that should be used during the COVID-19 outbreak.15 Healthcare
employers must also comply with Occupational Safety and Health Administration standards that
15 https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.

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require PPE to protect workers and that apply to infectious disease hazards.16
FDA recommends that face masks are to be used for source control, and are not personal protective
equipment.17 Additionally, FDA recommends that barrier face coverings can also be used for source
control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate
matter. By definition, these devices should meet the submicron particulate filtration efficiency,
airflow resistance, and leakage assessment recommendations as described in the ASTM F3502
standard. However, neither face masks nor barrier face coverings are a substitute for NIOSH-
approved respirators (including N95 respirators), which provide respiratory protection to the wearer,
or for surgical masks, which provide fluid barrier protection and particulate filtration to the wearer.
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, in April 2020, FDA issued an EUA for certain face masks18
that FDA determined met the criteria for issuance under Section 564 of the FD&C 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 or -approved face masks are not available.
To help foster the availability of equipment that might offer some benefit to HCP and the general
public, FDA is continuing its April 2, 2020, policy regarding face masks, recognizing there is some
overlap with the EUA. Furthermore, FDA is also including barrier face coverings within the scope of
this policy given that they may be used as source control that also provides some measured degree of
particulate filtration. Thus, while this policy is in effect, FDA does not intend to object to the
distribution and use of face masks and barrier face coverings, 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 or barrier face covering does not create an undue risk: 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 Part 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. In addition, FDA generally does not intend to
object, while this policy is in effect, to the further distribution and use of existing stockpiles of non-
NIOSH-approved disposable FFRs for use as face masks for source control (as opposed to use as
FFRs for respiratory protection) by the general public and HCP without compliance with the
aforementioned regulatory requirements, where the non-NIOSH-approved FFR does not create an
undue risk. This policy aims to provide flexibility in situations where healthcare facilities, states, and
other stakeholders continue to have a supply of such FFRs following CDC’s and FDA’s
recommendations to return to conventional capacity strategies and following FDA’s revocation of the
16 See 29 CFR Part 1910, subpart I.
17 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.
18 https://www.fda.gov/media/137121/download.

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non-NIOSH-approved FFR EUAs.19
FDA currently believes such face masks 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 barrier face covering, surgical mask, or respirator)20 and includes a list of the
body-contacting materials;
· For non-NIOSH-approved FFRs to be used as face masks, the non-NIOSH-approved FFR is
segregated from NIOSH-approved FFRs and clearly identified as a face mask for use as
source control only;
· The product does not include any drugs, biologics, or nanoparticles;
· The product includes labeling that recommends against use in certain environments, such as
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;21 and
· The product is not intended for any use that would create an undue risk; for example, the
labeling does not include uses for antimicrobial or antiviral protection, infection prevention or
reduction, or related uses; and the labeling does not include uses for particulate filtration.22
FDA currently believes such barrier face coverings would not create such an undue risk where:
· The product includes labeling that accurately describes the product as a barrier face covering
(as opposed to a face mask, surgical mask, or respirator) and includes a list of the body-
contacting materials;
· The product does not include any drugs, biologics, or nanoparticles;
· The product includes labeling that recommends against use in certain environments, such as
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;
19 See Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators -
Letter to Health Care Personnel and Facilities, available at https://www.fda.gov/medical-devices/letters-health-care-
providers/update-fda-no-longer-authorizes-use-non-niosh-approved-or-decontaminated-disposable-respirators.
20 As mentioned, FDA generally does not intend to object to stockpiled, non-NIOSH-approved respirators being further
distributed and used as face masks for source control (as opposed to being used as FFRs for respiratory protection) where
the non-NIOSH-approved FFR is segregated from NIOSH-approved FFRs and clearly identified as a face mask to be
used for source control only.
21 See footnote 20.
22 See footnote 20.

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· The product is not intended for any use that would create an undue risk; for example, the
labeling does not include uses for antimicrobial or antiviral protection, infection prevention or
reduction, or related uses; and
· The product is labeled as a barrier face covering and is evaluated in accordance with 42 CFR
Part 84 and consistent with the currently FDA recognized version of ASTM F3502: Standard
Specification for Barrier Face Coverings.23 This includes assessments of submicron
particulate filtration efficiency and airflow resistance. The product is also labeled consistent
with, and meets, the design, leakage assessment, material, and flammability criteria as
described in the standard.
VI. EUAs for Face Masks Intended for a Medical Purpose
As mentioned in Section V above, EUAs have been issued for face masks for use by the general
public and HCP as source control.24 These EUAs have helped increase availability of these devices to
HCP and the general public, as applicable, during the public health emergency.
For any face mask issued an EUA, FDA has included 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, subsequent EUAs, if authorized, would 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.
23 Please refer to the FDA’s Recognized Consensus Standards database for additional considerations regarding use of this
standard: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=42029.
24 https://www.fda.gov/media/137121/download.

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· For manufacturers of the device, appropriate conditions concerning recordkeeping and
reporting, including records access by FDA, with respect to emergency use of the device.