FDA Guidance On Transitioning COVID-19 EUA Products Has US Firms Watching The Clock

Stakeholders across medtech industry submit comments on FDA's itsplans to help companies looking to keep their EUA products on the market post-pandemic.

PHE Sign on Tablet
• Source: Alamy

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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