The U.S. Food and Drug Administration (FDA) removed the emergency-use authorization (EUA) status from some disposable filtering facepiece respirators after a number of those products failed to demonstrate a minimum particulate filtration efficiency of 95 percent in independent testing, the agency announced in a news release.
Specifically, the agency is revising one criterion in its EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China. Before the revision, respirators would be authorized for inclusion on a list of EUA devices if manufacturers or importers submitted to the FDA reports on performance from recognized independent test laboratories. In the reissued EUA, the FDA no longer allows respirators to be included on the EUA list based on that criterion.
The FDA made the change because some of those respirators subsequently failed to pass testing conducted by the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH), which is part of the of the Centers for Disease Control and Prevention (CDC). As a result, the FDA removed from this respirator EUA list, any device that had been approved under that criterion—regardless of whether it passed or failed NIOSH testing.
Non-NIOSH-approved respirators that meet the other eligibility criteria in the reissued EUA remain authorized by the FDA for use during the COVID-19 pandemic, the agency said.
Respirators that were removed from the EUA list for respirators and that did not meet their labeled performance standard may not be marketed or distributed in the United States as respirators, the FDA said. They may be re-labeled as face masks if they meet criteria under the FDA’s umbrella EUA for face masks.
