FDA Revokes Some Emergency PPE Approvals

FDA revokes emergency use authorizations for some respirators and decontamination systems as access to N95s improves

(RxWiki News) As the landscape of the pandemic changes, the US Food and Drug Administration (FDA) is changing up the kinds of personal protective equipment (PPE) items that are approved for use.

As access to gold-standard N95 masks improves across the United States, the FDA has revoked its emergency use authorizations (EUAs) for certain respirators and decontamination systems.

The FDA initially issued these emergency approvals because health care providers were struggling to get access to N95 respirators during the pandemic. Now, access to this and other kinds of essential PPE has improved.

Now, the agency has decided to revoke the EUAs for all disposable respirators that have not been approved by the National Institute of Occupational Safety and Health (NIOSH). The FDA said it is also revoking EUAs for decontamination and bioburden reduction systems.

"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," said Dr. Suzanne Schwartz, director of the FDA's Office of Strategic Partnerships and Technology Innovation, in a press release. "Today, those conditions no longer exist. Our national supply of NIOSH-approved N95s is more accessible to our health care workers every day."

Dr. Schwartz also said that health care providers should consider relaxing the guidelines they put in place at the start of the pandemic to conserve certain types of PPE.

"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,” she said.

These actions by the FDA are in line with recent recommendations from the Centers for Disease Control and Prevention (CDC), which said health care providers should mostly return to their conventional, pre-pandemic care practices.

The standard N95 mask is by no means the only respirator now approved for use. Since the COVID-19 pandemic began, NIOSH has approved over 875 respirator models, the FDA said. In total, more than 6,400 respirator configurations and models have been cleared by NIOSH.

In recent weeks, COVID-19 case numbers have slowed down in many parts of the country. That's thanks in large part to COVID-19 vaccinations. Still, some areas are experiencing high case numbers.

If you are concerned about your COVID-19 risk, ask your health care provider which protection measures you should take.

Review Date: 
July 8, 2021