De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?

Medical Device Global Market Access

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 might the standard of care in your EU study be a problem for the FDA? • Is a US-based clinical trial always necessary if you already have CE mark data? • What is a "bridging study" and when might you need one? • How can a Pre-Submission meeting with the FDA save you time and money? • What key FDA guidance from April 2015 governs the use of foreign clinical data? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.