FDA Revokes Respirator EAUs, Protecting American Manufacturers and Workers

Yesterday, June 30, 2021, the U.S. Food and Drug Administration (FDA) announced it is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems. These devices will no longer be authorized for use by health care personnel in health care settings.

This move comes after ISEA, together with the American Mask Manufacturers Association (AMMA), requested the FDA take immediate steps to revoke these EAUs. In their joint letter,  ISEA and AMMA recommended the EUA allowing NIOSH-approved respirators to be used in healthcare workplaces to remain in place.

In response to FDA’s action, Johnson added, “We applaud the FDA for taking swift action to revoke these EUAs ensuring health care workers have access to the highest quality personal protective equipment that is guaranteed to perform as expected.”

“During the COVID pandemic, manufacturers of NIOSH-approved respirators increased production to record levels and can confidently meet current and future demand. Rolling back stop-gap emergency measures is the right move at this time  American health care professionals deserve reliable, US government approved protection.”

Respiratory protection manufacturers continue to work with the government, states, and health care networks to assist in increasing inventory of available NIOSH-approved respirators, including N95s and other disposable filtering facepiece respirators (FFRs), Elastomeric respirators, and Powered air-purifying respirators (PAPRs).

“The safety equipment industry is dedicated to ensuring employers and workers are prepared for future emergencies,” said Johnson,” with access to the appropriate safety equipment they need to stay protected.”

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