Options with an Overly Burdensome FDA—Mike on Medtech

Options with an Overly Burdensome FDA—Mike on Medtech

Mike Drues and Sean Fenske discuss the routes a company can take when they think the agency is asking too much of them.

By Sean Fenske, Editor-in-Chief10.19.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifically, the following questions are addressed:

  • If after a 510k submission or pre-sub meeting, is there something you can do if you feel the FDA is being overly burdensome? Can you do something if you think the agency is asking more of you than of your competitors?
  • What informal actions can you take?
  • If you’ve had no success with the informal options, are there formal actions you can take?
  • What about least burdensome? Can you cite that with any success?
  • Are there consequences to embarking on any of these actions? Might a company face pushback for questioning the agency?
  • What are the most important items medical device manufacturers need to keep in mind if they choose to question the FDA?

Listen to this episode and see what you think of the options available to you in dealing with the FDA if it’s being overly burdensome. 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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