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Mike on Medtech

FDA’s Third-Party Review Program—Mike on Medtech

Mike Drues and Sean Fenske discuss the agency’s program, how it’s used, and why no one really knows much about it.

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By: Sean Fenske

Editor-in-Chief, MPO/ODT
FDA’s Third-Party Review Program—Mike on Medtech

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that added expense. Other factors and considerations are also reviewed. During this conversation, the following questions are addressed:

  • If I need to get a 510k clearance on my new medical device, is going through the FDA my only option?
  • Under what circumstances should a sponsor consider using the third-party review program?
  • Under what circumstances should a sponsor not consider using the third-party review program?
  • How popular is the third-party review program, i.e., why are many people not familiar with it?
  • Can you provide some examples of devices that have gone through the third-party review program.
  • What advice would you provide in choosing which third-party review organization to work with?
  • What are the key steps when considering using the third-party review program?
  • When evaluating potential third-party review organizations, do you have recommendations on what questions to ask?
  • Is there anything like the third-party review program outside the US, i.e. is there any regulatory precedent?
  • What else is important, and what are today’s takeaways?

Listen to this discussion and see if you may have interest in the third-party review program. 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 your ideas/inquiries/suggestions align with a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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