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 FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.
A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.
Companies offering OTC sample collection kits to help diagnose COVID-19 quickly fell under scrutiny in the US because the FDA hasn’t authorized any OTC tests.