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Guidance Issuing OfficeCenter for Devices and Radiological Health
September 5 Update: The FDA is updating and renaming the guidance, "Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency" (latest version published March 2023), as "Enforcement Policy for Face Masks and Barrier Face Coverings for the Coronavirus Disease (COVID-19) Response." This guidance was originally part 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), which was split into the following two guidances in March 2023:
This revision of the previous version of the face mask and barrier face covering guidance does not affect the current policy and is intended only to facilitate a different timeline and process for transitioning back to normal operations, as further described in the declaration of the Secretary of Health and Human Services (HHS) on March 24, 2020 under section 564 of the Federal Food, Drug, and Cosmetic Act on the COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders web page.
All written comments on these two guidances should be identified with this docket number: FDA-2020-D-1138.
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). This policy is intended to remain in effect for the duration of that declaration, unless FDA revises or replaces this guidance.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1138.