October 22, 2020

FDA Will No Longer Authorize Respirators for Emergency Use Under Predetermined Eligibility Criteria

Last week, the U.S. Food and Drug Administration (FDA) reissued its Emergency Use Authorization (EUA) for certain non-NIOSH-approved, Chinese-manufactured filtering facepiece respirators in healthcare settings in the U.S. The reissued EUA, dated Oct. 15, authorizes only those respirators already authorized by FDA and included on its list of authorized respirators—known as Appendix A. Under a previous version of this EUA, respirators originating from China that were not approved by NIOSH had to meet one of three predetermined eligibility criteria to be approved for emergency use. According to the Oct. 15 EUA, FDA has determined that the eligibility criteria are “no longer appropriate” and removed them. FDA will no longer review requests or add additional respirator models to Appendix A under those criteria.

FDA’s EUA is informed by an assessment of product availability and use practices for both NIOSH-approved N95s and KN95 respirators. According to the assessment, KN95 respirator models authorized by the EUA meet the demand for these respirators. A news release from FDA describes direct feedback from healthcare personnel, distributors, and manufacturers that the KN95 design has limited adoption in healthcare settings, non-NIOSH-approved respirators from China are sitting in warehouses unused, and the production of NIOSH-approved N95 respirators is increasing. The agency also says that NIOSH continues to issue more 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.”

Visit the FDA website for the agency’s Oct. 15 EUA (PDF) and the updated list of authorized respirators.