Strengthening the 510k Program—Mike on Medtech

Strengthening the 510k Program—Mike on Medtech

Mike Drues and Sean Fenske discuss three recent guidances put out by the agency in an attempt to bolster the regulatory pathway.

By Sean Fenske, Editor-in-Chief12.19.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:

  • Can you please provide a brief explanation of the 510k pathway?
  • Why is the agency attempting to strengthen the program? What is their ultimate goal?
  • With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?
  • What other best practices are tied to the predicate device selection?
  • How do you gather clinical data on a device that’s not cleared or approved and just being submitted to the FDA?
  • For what situations is the agency considering clinical data in a submission and why?
  • For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?
  • What do these mean to you? What will they mean to medical device manufacturers?
  • What are the takeaways?

Listen to this discussion and let us know what you think of any or all of these guidances. 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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