The head of the FDA says some changes the agency made during the height of the COVID-19 pandemic will become permanent.
Dr. Stephen Hahn told members of the Medical Device Innovation Consortium (MDIC) on June 19 that the agency will rely even more on real-world evidence regarding the performance of approved or cleared devices and update its decisions on devices when necessary. The FDA had to boost its reliance on real-world evidence during the pandemic as it weighed which devices and tests qualified for emergency use authorizations (EUAs).
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