FDA Changes Emergency Use Authorization for FFRs in Healthcare
The U.S. Food and Drug Administration has reissued its Emergency Use Authorization (EUA) for the use in healthcare settings of certain non-NIOSH-approved filtering facepiece respirators, or FFRs, manufactured in China. The reissued EUA, dated Oct. 15, authorizes only those respirators already listed in the associated Appendix A. In the earlier version of the EUA, respirators originating from China that were not approved by NIOSH could be acceptable for emergency use under previously established eligibility criteria. According to FDA, these criteria are “no longer appropriate,” and FDA will no longer use them to review requests or add additional respirator models to Appendix A.
FDA’s EUA is informed by an assessment of product availability and use practices for both N95 respirators, approved by NIOSH, and KN95s, the standard in China. The assessment found that KN95 respirator models authorized by the EUA meet the demand for respirators, but also that healthcare personnel, distributers, and manufacturers favored NIOSH-approved respirators. The agency also says that NIOSH continues to issue N95 approvals.
FDA intends to continue working with NIOSH to “help facilitate the availability of respiratory protection that meets the applicable standards and demands of healthcare personnel.” For more information, read FDA’s letter of authorization to stakeholders for the Oct. 15 EUA (PDF) and the related press release.