More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the National Institute of Occupational Safety and Health (“NIOSH”) and related decontamination and bioburden reduction systems. The decision follows the agency’s May 27, 2021 letter to healthcare personnel and facilities recommending a transition away from non-NIOSH FFRs approved by the agency under the EUAs. The June announcement specifically revoked the following three EUAs:
• Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
• Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
• Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
Additionally, the agency withdrew two-related decontamination and bioburden reduction guidance documents:
• Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
• Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease (2019) Public Health Emergency
The revocation of non-NIOSH approved respirator EUAs comes in response to recommendations from the Occupational Safety and Health Administration (“OSHA”) emergency temporary standard requirements, Centers for Disease Control and Prevention (“CDC”) recommendations, and the increased supply and availability of NIOSH-approved respirators. This response signals the FDA’s shift away from crisis capacity conversation strategies. And, it shows the FDA is monitoring supply and demand to assess respirator availability as facilities transition from crisis and contingency strategies to conventional use. For example, surgical respirators remain on the FDA’s Device Shortage List, and we do not expect FDA to revoke this EUA in the near term. Overall, we expect the agency to continue to revoke more EUAs and guidance related to PPE as the industry transitions to a post-crisis response.
During the global COVID-19 pandemic, manufacturers, healthcare personnel, and industry participants should continue to monitor FDA’s actions in this changing landscape as part of overall risk management and compliance. The agency currently recommends that healthcare personnel and facilities utilize only FDA-cleared or NIOSH-approved respirators – including those under the EUA for NIOSH-approved respirators – and to transition away from wearing disposable respirators for extended periods of time. FFRs under the revoked EUAs could be redistributed for non-medical use or provided to countries experiencing need based on FDA export guidelines.
Moving forward, the agency indicated it also intends to revise the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) to align with the changes to its EUAs as well as the EUA for NIOSH-approved respirators. Please continue to monitor Triage for further developments.