Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. FDA revoked the Authorizations for the decontamination and bioburden reduction systems for personal protective equipment on June 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. FDA revoked the umbrella Authorizations issued to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators manufactured in China (China FFR Authorization), and to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators (Imports FFR Authorization) on June 30, 2021, under the FD&C Act. The revocations, which each include an explanation of the reasons for the revocation, are reprinted in this document.