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Today, the U.S. Food and Drug Administration (FDA) updated the guidance: Enforcement Policy for Face Masks and Barrier Face Coverings for Coronavirus Disease (COVID-19) Response.
The update includes:
- separating the policy in this guidance from the transition timeline related to the declaration of COVID-19 public health emergency under section 319 of the Public Health Service Act, and
- reflects the FDA’s intent for the guidance to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that circumstances exist justifying emergency use authorization of medical devices, including alternative products used as devices.
This update was issued to help address urgent public health concerns by clarifying the regulatory landscape of face masks and barrier face coverings and helping to expand the availability of these medical devices for use by the general public and health care personnel in health care settings, as appropriate.
This guidance supersedes the guidance, “Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” last updated March 2023.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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