FDA no longer authorizes non-NIOSH respirators, respirator decontamination

The Food and Drug Administration yesterday revoked its emergency use authorizations for all disposable respirators lacking National Institute of Occupational Safety and Health approval, and for decontamination and bioburden reduction systems used to extend the use of disposable respirators.

In a letter to health care providers, FDA said providers should no longer use these crisis capacity strategies based on the increased domestic supply of NIOSH-approved respirators. It said the change also was consistent with the Centers for Disease Control and Prevention’s updated recommendations for maximizing the supply of N95 respirators and the Emergency Temporary Standard recently published by the Occupational Safety and Health Administration.

In May, FDA recommended providers transition away from using disposable respirators not approved by NIOSH and decontamination or bioburden reduction to extend the use of disposable respirators due to increased supply of NIOSH-approved respirators.