What Happens When FDA Ends Medical Device and IVD Emergency Use Authorizations (EUAs)?

Throughout the spring and summer of 2020, there was a mad rush to get ventilators, COVID-19 tests, masks, and personal protective gear on the market as quickly as possible. The existing supply of FDA-cleared / -approved devices and in vitro diagnostics (IVDs) could not come close to filling the need, so FDA granted emergency use authorizations (EUAs) for dozens of products. Established medical device manufacturers jumped in to fill the void but so did companies that had no previous experience […]
» Read more