The FDA is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021).
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021, letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators.
The following quote is attributed to Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health.
“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.”