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GUIDANCE DOCUMENT

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 March 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-1138
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

March 10, 2023 Update: The FDA divided into two 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). The two new guidances have no changes to the enforcement policy:

This division of the previous version of the 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 Federal Register notice on this topic and 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 for 180 days following expiration of the COVID-19 public health emergency declaration under section 319 of the Public Health Service Act (42 U.S.C. 247d(a)(2)), unless superseded by a revised final guidance before that date. For further information, please refer to the Federal Register notice titled "Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)."

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

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