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Latest From Elizabeth Orr
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.
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.
The US agency’s device center has offered an extension on some submission deadlines and announced a transition to teleconferences from in-person meetings during the COVID-19 pandemic.
A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.
Manufacturers can expand the remote-use capabilities of patient-monitoring devices like thermometers and stethoscopes without alerting the US FDA during the coronavirus crisis, a new guidance document from the agency says.
Edwards’ Pascal transcatheter valve repair devices has been blocked from most use after being found to infringe on Abbott’s patents by a British court.