FDA Reissues EUA on FFR From China

On Oct. 15, 2020, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators—known as Appendix A—of this EUA based on those criteria. Download and review the press release here.

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