Update on FDA's STeP Designation—Mike on Medtech

Update on FDA's STeP Designation—Mike on Medtech

Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.

By Sean Fenske, Editor-in-Chief02.26.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a still relatively newer option for medical device manufacturers in gaining a priority status with their regulatory review. STeP (Safer Technologies Program) emphasizes devices that enhance safety (as opposed to efficacy as is the case with the Breakthrough Device Program). Specifically, the following questions are addressed:

  • Can you please give us a brief overview of the program?
  • How does this program compare and contrast to the breakthrough devices program?
  • What’s been the latest updates to STeP?
  • What should companies consider or be aware of if they are looking at participating in this program?
  • Any additional comments or final thoughts on STeP?

You can view the STeP guidance from the FDA by clicking here.

Listen to this episode and see what you think of the STeP designation and if it is appropriate for a device you’re going to submit to the agency. 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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