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Mike on Medtech: Breakthrough Designation Program

Mike on Medtech: Breakthrough Designation Program

Sean Fenske and Mike Drues discuss the FDA's Breakthrough Designation Program and address common questions.

By Sean Fenske, Editor-in-Chief08.10.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a relatively new FDA regulatory review option—the Breakthrough Designation Program. Do you have questions about this program, how it impacts the device review process, what types of products are accepted, or other inquires? If so, this podcast is perfect as Mike explains a variety of factors that would impact a company’s decision as to whether the program is right for their product. Specifically, the following questions are addressed:

  • What is the breakthrough designation program?
  • How does a manufacturer apply for breakthrough designation?
  • Why are nearly half of breakthrough designation applications rejected and what should be done to avoid that?
  • What are the options for a company if its breakthrough designation application is rejected?
  • Are there non-regulatory advantages of obtaining breakthrough designation, such as public relations, fund-raising, etc.?

As mentioned during the podcast, further information about the Breakthrough Designation Program can be found at the FDA’s website in its draft guidance, which can be viewed here: Breakthrough Devices Program Draft Guidance [PDF file].

Listen to this episode and see if anything could use further explanation or you still have questions about any aspects of the 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 perhaps discuss them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

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.

Click here to review other episodes of Mike on Medtech.
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