The Rise of eSTAR for Medical Device De Novo Submissions
FDA Law Blog
OCTOBER 24, 2023
On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. Unlike 510(k)s, using eSTAR for De Novos does not eliminate the acceptance review process, which must be conducted and completed within 15 calendar days of FDA receiving a De Novo request.
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