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De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?
This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US requirements, and the strategic importance of the Pre-Submission program to de-risk market entry. • Can you directly use your CE mark clinical study for an FDA De Novo submission? • What are the most common data gaps the FDA identifies in European studies? • How does the FDA's view on patient demographics differ from European regulators? • Why…
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