FDA revokes emergency use authorization for non-NIOSH-approved disposable respirators

Washington — Prompted by an “increased domestic supply” of NIOSH-approved respirators, the Food and Drug Administration has revoked its emergency use authorizations for non-NIOSH-approved disposable respirators as well as decontamination and bioburden reduction systems.

Announced in a press release, the revocation of the authorizations went into effect July 6 and June 30, respectively, meaning the devices are no longer permitted for use by workers in health care settings.

The move comes after FDA in May recommended health care facilities transition away from strategies intended to conserve supplies of disposable respirators amid the COVID-19 pandemic. It’s also consistent, the agency says, with Centers for Disease Control and Prevention updated guidance and in alignment with OSHA’s emergency temporary standard on COVID-19 focused on health care workers, so “health care facilities should not use crisis capacity strategies any longer.”

FDA notes that NIOSH approved more than 875 respirator models or configurations between January 2020 and this past May. Some of those were manufactured by 20 or so new domestic NIOSH approval holders. Additionally, more than 6,400 approved respirator models or configurations are on NIOSH’s certified equipment list.

FDA recommends that health care workers and facilities:

• Use only FDA-cleared or NIOSH-approved respirators, such as N95s.
• Transition from wearing disposable respirators for extended periods of time to wearing a disposable respirator for each patient contact.
• Consider redistributing current inventory of non-NIOSH-approved respirators to non-health care settings and other countries in need.
• Continue to increase inventory of available NIOSH-approved respirators.

The International Safety Equipment Association issued a statement lauding FDA’s decision to revoke the authorizations.

“During the COVID pandemic, manufacturers of NIOSH-approved respirators increased production to record numbers and can confidently meet current and future demand,” ISEA President Charles Johnson said in the statement. “American health care professionals deserve reliable, U.S. government-approved protection.”