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
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Guidance Issuing OfficeCenter 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:
- Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency
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public health emergency declaration under section 319 of the Public Health Service Act (42 U.S.C. 247d(a)(2)), unless superseded by a revised final guidance before that date.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)."
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.