Binding vs. Nonbinding FDA Feedback—Mike on Medtech

Binding vs. Nonbinding FDA Feedback—Mike on Medtech

Mike Drues and Sean Fenske discuss what’s required of companies who receive nonbinding feedback from the FDA.

By Sean Fenske, Editor-in-Chief06.10.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the term “nonbinding feedback” and what it means for medical device manufacturers. While the feedback comes from the FDA, it’s not mandatory that the feedback (or advice or recommendation) needs to be followed. Specifically, we address a number of questions, including:

  • What does nonbinding mean with regard to input or advice from the FDA?
  • The nonbinding feedback we spoke about back in May 2019 had to do with 483s from site inspections. Where else does nonbinding feedback come into play with the FDA?
  • Although the FDA’s feedback or recommendation may be nonbinding, is it always a good idea to follow the advice?
  • What happens if you don’t follow nonbinding advice? Are you setting yourself up for a problem or a tougher “fight” with the FDA?
  • What are the most important takeaways with regard to how a company should handle nonbinding feedback?

Listen to this episode and see what you think of nonbinding feedback as well as how your company has reacted to it in the past. 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.

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