USA – US FDA lays out post-COVID EUA transition plans for medical devices

The US Food and Drug Administration has published transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency but that will require full regulatory registration to remain legally commercialized.

New draft guidance from FDA cover transition plans for devices granted EUA designations during the coronavirus pandemic; the guidance provides more clarity regarding how device manufacturers whose devices were made available via pandemic-era EUAs will be affected once the public health emergency abates. Industry and other stakeholders have 90 days to comment on FDA’s approach…