FDA Updates Emergency Use Authorization For Chinese Respirators

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and Health (NIOSH). The new EUA on non-NIOSH respirators from China adds new conditions for authorization and supersedes the agency's prior EUA from April 3, 2020. According to FDA, the revision was "in response to questions and concerns that have been received by FDA" and led the agency to conclude that revision "is appropriate to protect the public health or safety".

Under the earlier EUA, a disposable non-NIOSH-approved respirator manufactured in China was eligible for authorization if it met any one of the following three criteria: