COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators
Executive Summary
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.
You may also be interested in...
No Longer In Short Supply: US FDA Pulls N95s From Shortage List
The US FDA has removed N95s respirator masks from its medical device shortage list, citing increased domestic production.
FDA Comes Down On Another Chinese N95 Manufacturer
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.
FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems
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.