FDA Revokes EUAs for Certain Non-NIOSH-Certified Respirators

By MedTech Intelligence Staff

The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.

The FDA is revoking EUAs of all non-NIOSH ((National Institute of Occupational Safety and Health)-approved disposable, filtering facepiece respirators.

Suzanne Schwartz, M.D., director of the Office of Strategic Partnerships and Technology Innovation at CDRH, made the following statement about the agency’s decision:

“Throughout the pandemic, the FDA has worked closely with our federal partners at the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA) and with manufacturers to protect our front-line workers by facilitating access to the medical supplies they require. As a result of these efforts, our country is now better positioned to provide health care workers with access to NIOSH-approved N95s rather than using non-NIOSH-approved respirators or reusing decontaminated disposable respirators.

Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators. Today, those conditions no longer exist. Our national supply of NIOSH-approved N95s is more accessible to our health care workers every day.
Today, the FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. 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.”

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