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Emergency Use Authorizations for some respirators and
decontamination systems has been revoked
by Food and Drug Administration (FDA).
Medical supply needs of the front-line/healthcare workers during the coronavirus disease 2019 (COVID-19) pandemic led to emergency use authorizations (EUAs) of non-NIOSH (National Institute for Occupational Safety and Health)-sanctioned respirators and decontamination and bioburden reduction devices. But, today, the supply of NIOSH-sanctioned N95s are readily available than ever, and the supply of disposable respirators continues to improve drastically.
On 30 June 2021, FDA announced the withdrawal of EUAs for imported, non-NIOSH- sanctioned respirators along with decontamination and bioburden reduction systems due to an increase in domestically-manufactured NIOSH- sanctioned N95s available all over the country. This announcement is in accordance with revised proposals of the Centers for Disease Control and Prevention (CDC) that health care facilities should not use crisis capacity approaches and should quickly get back to the standard routines.
It is also in harmony with the newly issued Emergency Temporary Standard (ETS) by the Occupational Safety and Health Administration (OSHA), which entails healthcare employers to supply NIOSH- sanctioned or FDA-authorized respirators for the protection of workers possibly imperilled to COVID-19.
NIOSH has sanctioned more than 875 models or
designs of the respirators ever since the dawn of COVID-19. Today, this number rose to
more than 6,400 total respirator models or designs that are FDA-authorized on
the NIOSH- authorized equipment list and has fulfilled the NIOSH-sanctioned EUA
criteria.
FDA
FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
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