FDA’s De Novo Classification Process — Challenges and Opportunities

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March 09, 2017
01:00 PM - 01:45 PM ET
12:00 PM - 12:45 PM CT
10:00 AM - 10:45 AM PT

Join us for a discussion about the Food and Drug Administration’s (FDA’s) de novo classification process for novel medical devices. Since the de novo process was streamlined under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) and the FDA has limited the use of multiple predicates in 510(k) submissions, this process has become an increasingly important premarket pathway option, particularly for lower-risk novel and significantly modified device technologies. Although the de novo review process has greatly improved, challenges remain as the FDA and industry work through the kinks of a relatively new premarket approach. 

Join us for a discussion on the issues and opportunities device manufacturers should evaluate when considering whether to submit de novo requests.


  • FDA review times and trends for de novo requests
  • Impact of the 2017 Medical Device User Fee Amendments (MDUFA IV), including new (and significant) user fees for de novo requests
  • Ambiguities concerning the standard of review and data requirements
  • Risks for follow-on devices and strategies to mitigate such risks
  • Issues to consider when drafting special controls