Multiple Function Device Products—Mike on Medtech

Multiple Function Device Products—Mike on Medtech

Mike Drues and Sean Fenske discuss what a Multiple Function Device Product is and how the FDA's guidance impacts manufacturers.

By Sean Fenske, Editor-in-Chief09.17.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidance on Multiple Function Device Products. While the terminology can be somewhat confusing, the guidance, and more importantly, how manufacturers comply with it is relatively straightforward. Specifically, we address a number of questions, including:

  • What is a multiple function device as it relates to the FDA’s guidance?
  • What’s the difference between a regulated medical device and a consumer product?
  • How does something like a multiple function device differ from a combination product?
  • What regulatory strategy suggestions do you have for dealing with this type of device?
  • What concerns exist from a regulatory viewpoint if a sensor, such as a camera, is updated for non-regulated purposes? Will that impact the clearance of a regulated product that leverages that camera for sensing, such as a visual detection app that can detect skin cancer?
  • What other significant takeaways from this guidance must manufacturers keep in mind?

Listen to this episode and see what you think of the Multiple Function Device Products guidance and whether it could affect an upcoming product you are producing. 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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