Communicating with the FDA—Mike on Medtech

Communicating with the FDA—Mike on Medtech

Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.

By Sean Fenske, Editor-in-Chief12.15.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a variety of ways in which medical device manufacturers communicate with the FDA. Mike provides best practices he’s used and also shares stories from his own experience interacting with the agency for real-world projects. Specifically, we address a number of questions, including:

  • Let’s review the more common or well-understood methods of communicating with the FDA.
    • Regulatory submission
    • Response to inspection or 483
    • Pre-sub meeting
    • Social media
    • Letter to file
  • What other methods are there outside of those?
  • How has communication been handled during the pandemic?
  • Can you share best practices when communicating with the FDA? Dos and don’ts?
  • What ways would you like to see established for communication with the FDA?

Listen to this episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. 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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