FDA's Intended Use Rule’s Relation to Labeling—Mike on Medtech

FDA's Intended Use Rule’s Relation to Labeling—Mike on Medtech

Mike Drues and Sean Fenske review the agency’s Intended Use rule that was made final last year and discuss its impact on labeling.

By Sean Fenske, Editor-in-Chief11.01.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:

  • Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?
  • How can labeling, both high level and low level, be used as a strategic advantage?
  • Could you please explain the difference between intended use and indications for use?
  • What is this intended use rule and why is it important to medical device manufacturers?
  • What is meant by manufacturer's objective intent?
  • Do you have examples you can provide?
  • What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how Intended Use affects your device labeling. 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.

Click here to review other podcasts.