De Novo Final Rule—Mike on Medtech

De Novo Final Rule—Mike on Medtech

Mike Drues and Sean Fenske discuss the recently announced final rule from FDA for its de novo regulatory pathway and the details within.

By Sean Fenske, Editor-in-Chief10.26.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Specifically, the following questions are addressed:

  • Can you please briefly explain what the de novo regulatory pathway is?
  • How does this option differ from the 510(k) and PMA?
  • When is the de novo used?
  • Were there any surprises or changes made in the final rule as issued?
  • Apparently there was some dissatisfaction with the agency not removing inspection requirements in the final rule. Can you explain why this was an issue?
  • What should device makers keep in mind if they are exploring the de novo regulatory pathway for a product?

Listen to this episode and see what you think of the de novo regulatory pathway. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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