Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech

Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech

Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.

By Sean Fenske, Editor-in-Chief08.06.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:

  • What is the purpose of the Breakthrough Devices Program and why does it exist?
  • Is the BDP a “pathway” to market like the 510k or PMA?
  • How early in the product development lifecycle should we consider a BDP?
  • What are the requirements of the Breakthrough Devices Program?
  • What are the mechanics of the process?
  • What goes into the BDP Pre-Sub Package?
  • What is the benefit of BDP status?
  • What if you don’t like FDA’s decision, can I appeal?
  • Is there a database of BDP devices?
  • Should we issue a press release announcing our BDP designation?
  • What’s the most important thing to remember about the BDP program?

Listen to this episode and see what you think of the Breakthrough Devices Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming 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.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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