Off-Label Use—Mike on Medtech

Off-Label Use—Mike on Medtech

Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.

By Sean Fenske, Editor-in-Chief08.25.17
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:

  • What is off-label use as it relates to a medical device?
  • What are the limitations of off-label use? Where is the real line between what’s allowed and what’s not?
  • How are off-label use and real-world evidence connected?
  • Can a device manufacturer advertise off-label use without going to jail?
  • How might FDA’s view of advertising off-label use change in the future?
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 at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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