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FDA Revokes EUAs For Certain Respirators And Decontamination Systems

fda march25 02jul21 lt

The U.S. Food and Drug Administration is revoking emergency use authorizations or EUAs for certain respirators and decontamination systems as access to N95s increases across the United States.

In a statement, the regulator said it is revoking EUAs of all non-NIOSH (National Institute of Occupational Safety and Health) -approved disposable respirators, which includes imported disposable respirators such as KN95s. The FDA is also revoking EUAs for decontamination and bioburden reduction systems.

The decision is due to an increase in domestically-manufactured NIOSH-approved N95s available throughout the country.

Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health, said, "As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic."

The FDA noted that during the initial stage of the public health emergency, there was a need to issue EUAs for non-NIOSH-approved respirators and decontamination and bioburden reduction systems to disinfect disposable respirators.

However, those conditions no longer exist as national supply of NIOSH-approved N95s is more accessible to health care workers every day.

According to Schwartz, the FDA worked with federal partners at the Centers for Disease Control and Prevention's NIOSH, the Occupational Safety and Health Administration or OSHA and with manufacturers for facilitating access to the medical supplies the frontline workers require.

With this, the health care workers now have access to NIOSH-approved N95s rather than using non-NIOSH-approved respirators or reusing decontaminated disposable respirators.

Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by around 20 new, domestic NIOSH-approval holders.

At present, there are more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list which have met the NIOSH-approved EUA criteria and thus are FDA-authorized.

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