July 8, 2021

FDA Revokes EUAs for Certain Respirators, Decontamination Systems

The U.S. Food and Drug Administration has revoked its Emergency Use Authorizations for non-NIOSH-approved disposable respirators and its EUAs for decontamination and bioburden reduction systems. According to FDA, these actions are consistent with CDC recommendations from May 2021 that urge healthcare facilities to stop using crisis capacity strategies and “promptly resume conventional practices,” including the use of only NIOSH-approved respirators where needed. FDA’s EUA revocations also align with OSHA’s new emergency temporary standard for healthcare settings, which requires employers to provide NIOSH-approved or FDA-authorized respirators for workers who are potentially exposed to COVID-19. A letter to healthcare personnel accompanying FDA’s recent announcement recommends that healthcare workers “transition from extended use of disposable respirators to single-use for single-patient interactions as appropriate.”

According to Suzanne Schwartz, a director in FDA’s Center for Devices and Radiological Health, “access to domestic supply of disposable respirators continues to significantly improve” and the United States’ “national supply of NIOSH-approved N95s is more accessible to [its] healthcare workers every day.”

The revocation of the EUAs for imported, non-NIOSH-approved disposable filtering facepiece respirators (FFRs) such as KN95s and for non-NIOSH-approved disposable FFRs manufactured in China became effective on July 6. FDA’s revocation for the decontamination and bioburden reduction system EUAs for personal protective equipment is effective as of June 30.

See FDA’s announcement for further details.