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FDA Revises Umbrella EUA for Surgical Masks Used During COVID-19 in Response to Stabilized Supply

Today, the U.S. Food and Drug Administration (FDA) revised and reissued the umbrella Emergency Use Authorization (EUA) for disposable, single-use surgical masks intended for use in health care settings by healthcare professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer be adding surgical mask models to Appendix A. Manufacturers who would like to bring new surgical masks to market should follow traditional premarket pathways, such as a premarket notification, or 510(k). Manufacturers can refer to the FDA’s guidance on surgical masks for further information.

Questions?

If you have questions about Emergency Use Authorizations related to surgical masks, contact the Division of Industry and Consumer Education.