The FDA said June 30 it is revoking emergency use authorizations for all face masks not approved by the CDC's National Institute for Occupational Safety and Health, as well as decontamination systems used to reuse masks.
Early in the pandemic, the FDA issued the emergency authorizations so healthcare providers could use masks not approved by NIOSH as well as machines to decontaminate and reuse masks that were intended for single use because supplies of face masks were so severely limited.
But, Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health, says "our country is now better positioned to provide healthcare workers with access to NIOSH-approved N95s rather than using non-NIOSH-approved respirators or reusing decontaminated disposable respirators."
The FDA is revoking the emergency authorizations for all imported non-NIOSH-approved masks, including KN95 masks.
"As access to domestic supply of disposable respirators continues to significantly improve, healthcare organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic," Dr. Schwartz said.
Read the FDA's full news release here.