Breakthrough Designation Program Update—Mike on Medtech

Breakthrough Designation Program Update—Mike on Medtech

Mike Drues and Sean Fenske revisit the breakthrough designation program and talk about the changes that have occurred since its inception.

By Sean Fenske, Editor in Chief08.28.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss how the breakthrough designation program (BDP) has changed since its inception. While the language of the program has not changes, FDA’s interpretation of it has shifted somewhat. Find out what’s “new” in this episode. Specifically, we address a number of questions, including:

  • Can you remind us what the BDP is? Why was it created? Who should consider it?
  • How is the 510k pathway able to be used in conjunction with this program?
  • How does the BDP differ from the STeP (or Safer Technologies Program)?
  • So what’s “new” in the BDP? Why are we talking about it again?
  • In what ways could the program be improved still?

Listen to this episode and see what you think of the BDP and whether it could be for an upcoming product you are producing. 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.

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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