FDA Issues Emergency Authorized Use for Manufacturers of Face Masks – Update from Bergeson & Campbell, P.C.

The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE) shortages for face masks, but only for the general public and health care personnel (HCP) within a specified scope. For more information, please read the full memorandum.

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