Search

Home > Medtech Matters > How Can Off-Label Use Be Promoted?
Podcast: Medtech Matters
Episode:

How Can Off-Label Use Be Promoted?
Category: Health
Duration: 00:48:46
Publish Date: 2022-11-15 14:00:00
Description:

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:

  • Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?
  • Can you speak to the relationship between intended use and off-label use?
  • When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?
  • To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?
  • Can you share a couple real-world examples of acceptable off-label promotion?
  • Where is the cut-off? In other words, what should companies be sure they AREN’T doing with regard to off-label promotion?
  • What are the most important takeaways with all of this for medical device manufacturers?


Listen to this episode and see if you’re able to promote an off-label use of one of your devices. 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.
Total Play: 0