FDA's eSTAR Program—Mike on Medtech

FDA's eSTAR Program—Mike on Medtech

Mike Drues and Sean Fenske discuss a pilot the FDA is conducting that would have the agency providing an interactive 510(k) template to submitting firms.

By Sean Fenske, Editor-in-Chief03.03.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pilot of an interactive 510(k) template called eSTAR (electronic Submission Template and Resource). This electronic template would be used by companies submitting a 510(k) application so as to try to avoid administrative rejection, one of the most common causes of submission rejection. Specifically, we address a number of questions, including:

  • What is the eSTAR program?
  • What is the goal of this program?
  • What is FDA seeking from companies interested in participating in the trial?
  • For what types of devices/510(k) submissions can eSTAR be used and which types can it not be used?
  • What does the form ask for?
  • Is FDA offering incentives to encourage manufacturers to use eSTAR?
  • What challenges do you foresee with this template? Has the FDA neglected to consider anything?
  • If this template goes into effect, do you expect it to speed up 510(k) submissions and/or the processing of them?
  • Would you encourage a company to participate in the pilot if they meet the criteria?

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.

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