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FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems

The US agency says there are now at least 6,400 NIOSH-approved respirators or configurations that can sufficiently meet the domestic supply needs of health care workers.

A man throwing a facemask in the trash

The US Food and Drug Administration has revoked emergency use authorization (EUA) for certain imported respirators for health care workers, and decontamination systems that were allowed due to a shortage of domestic N95 masks. However, the agency says domestic manufacturers are able to produce enough high-grade masks and recommends the lower-grade masks may be exported to countries that are still lacking in personal protective equipment.

In the early days of the coronavirus pandemic, the FDA was forced to authorize EUAs for certain respirators not approved...

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