October 19, 2020

FDA reissues EUA for N95 respirators manufactured in China

Editor's Note

The Food and Drug Administration (FDA) on October 15 announced that it reissued the Emergency Use Authorization (EUA) for certain N95 and other filtering face-piece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health.

Effective immediately, the reissued EUA no longer includes three eligibility criteria that were required under the June 6 version. This means the FDA will no longer review requests nor add to the list of authorized respirators based on those criteria.

The FDA recognizes there is still a shortage of respirators, and to provide additional capacity, the agency is continuing the EUA of models already on the list of authorized respirators.


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