The FDA narrowed its umbrella emergency use authorization for disposable, single-use surgical masks used in healthcare on March 6 after more than two years of the EUA prompted by the COVID-19 pandemic.
The availability of surgical masks used by healthcare workers was rocky early in the pandemic, but the FDA said “the totality of scientific evidence available, which includes information regarding supply, demand and distribution” and requests for more surgical masks to be part of the EUA led to the revision.
The updated EUA only allows specific surgical masks already authorized, meaning the FDA will not add other surgical masks to the authorization.
