The US Food and Drug Administration has granted hundreds of emergency use authorizations for medical devices and diagnostics available OTC as well as used by health care professionals since the COVID-19 public health emergency was declared in January 2020,
With many firms likely looking to keep their EUAs products on the market once the emergency ends, the FDA published guidance in December to help manufacturers transition their products to traditional clearances 510(k) and pre-market approval and avoid having to remove them from the market
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