FDA Pre-Sub Best Practices—Mike on Medtech

FDA Pre-Sub Best Practices—Mike on Medtech

Mike Drues and Sean Fenske discuss the most important factors to keep in mind when preparing to meet with the FDA during a pre-sub meeting.

By Sean Fenske, Editor-in-Chief04.24.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including:

  • Can you please give a brief overview of what the FDA’s pre-sub program is?
  • Is the pre-sub only for certain types of devices or when using certain regulatory pathways or is it available to all device makers?
  • Are there questions you shouldn’t ask during the pre-sub?
  • What’s the most common mistakes you’ve heard companies made during their pre-sub?
  • Will the FDA help a company determine what regulatory pathway to take during a pre-sub?
  • Will the FDA give recommendations on things such as testing protocols a certain type of device should go through during a pre-sub?
  • Is there any information you shouldn’t share with the FDA during a pre-sub? In other words, can being too transparent hurt you?
  • What’s the most important thing for a company to keep in mind with regard to a pre-sub?

There is also mention of the first podcast from 2017 where the pre-sub program was introduced and discussed. Click here to listen to that presentation.

Listen to this episode and see what you think of the eSTAR pilot program. 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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