FDA Revokes Authorization for Decontaminating and Reusing Chinese-Made N95 Respirator Masks

The FDA has revised its previous emergency authorizations for reprocessing N95 respirators, saying certain masks imported from China may not be able to withstand the decontamination process, according to a FierceBiotech report.

The agency said it received new information on the effective reuse of different models from researchers under the Centers of Disease Control and Prevention (CDC). More broadly, the FDA is no longer allowing the decontamination of any respirators featuring exhalation valves, and decontamination systems are only authorized by the agency to reprocess non-cellulose compatible N95 masks.

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