As the pandemic appears to be shifting away from a widespread emergency, FDA has revoked EUAs of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including imported disposable respirators such as KN95s, the agency reported last week. FDA has also revoked EUAs for decontamination and bioburden reduction systems, and it is now advising that healthcare personnel switch from extended use of disposable respirators to single-use for single-patient interactions as appropriate.
"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 healthcare workers every day," stated 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.
FDA stated that its revocations align with Centers for Disease Control and Prevention’s (CDC) updated recommendations that health care facilities not use crisis capacity strategies and should promptly return to conventional practices as well as Occupational Safety and Health Administration’s (OSHA) Emergency Temporary Standard (ETS) to protect health care workers, which requires healthcare employers to provide NIOSH-approved or FDA-authorized respirators for workers potentially exposed to COVID-19.
During the pandemic, emergency demand for masks prompted numerous innovations from medtech and beyond. While makers of NIOSH-approved N95 masks worked to meet heightened demand, other innovators stepped up with a range of solutions. Experts also suggested new approaches for personal protective equipment, and interest in anti-viral face masks emerged. And with the general public making and using cloth masks, ASTM published F3502-21, a standard specification for general-purpose face coverings that could help consumers understand covering filtration efficiency and more. The longer-term impact of these developments on future PPE innovations remains unclear.
FDA pointed out that NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. There are now more than 6400 total respirator models or configurations on the NIOSH-certified equipment list that have met the NIOSH-approved EUA criteria and thus are FDA authorized, FDA explained.
FDA did also state in "FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic" that "FDA device marketing authorization or clearance is not required for products that do not meet the definition of a device (for example, the product is labeled and marketed to the general public for general, non-medical purposes, such as use in construction)."
FDA has also withdrawn two related decontamination and bioburden reduction guidance documents:
- Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
- Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease (2019) Public Health Emergency
And in a letter to healthcare personnel, the agency is also advising that healthcare personnel transition from extended use of disposable respirators to single use for single-patient interactions as appropriate.