USA – FDA reissues Chinese respirator EUA, but freezes new additions

The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the COVID-19 pandemic continues. However, only respirators already authorized under the document’s earlier version will be covered under the reissued umbrella EUA.

The umbrella EUA was extended for certain filtering face-piece respirators made in China and not approved by the National Institute for Occupational Safety and Health (NIOSH).

However, FDA will no longer be adding to the list of respirators covered by the EUA and contained in an appendix to the EUA: “FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. Only those respirators listed in Appendix A as of the date of this reissuance are authorized by this EUA,” said the agency in an updated question and answer webpage regarding EUAs for non-NIOSH-approved respirators.
 
The reissued EUA no longer includes the three predetermined eligibility criteria contained in the June 2020 versions of the authorizations, precluding the addition of new respirators to the appended list…