COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators
The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.
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The US agency says Shanghai Dasheng didn’t put a quality management system in place, and as a result has lost NIOSH approval for its N95 respirators. The agency told health care workers to stop using the masks.
The US agency says there are now at least 6,400 NIOSH-approved respirators or configurations that can sufficiently meet the domestic supply needs of health care workers.
The US agency says it’s no longer going to update its list of certain imported respirators that are allowed on the market under an emergency use authorization for health care workers, or accept new applications for the face masks.