Emergency Use Authorisation isn't the best pathway because approval is only valid for duration of emergency and may not allow for expansions of product. De Novo submission is likely still the only viable pathway, however I know for a fact that FDA is prioritising devices applicable to covid.
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- Ann: Update on US FDA De Novo Classification Request
Ann: Update on US FDA De Novo Classification Request, page-316
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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