Performing a Gap Analysis on FDA's Regulatory Protocols—Mike on Medtech

Performing a Gap Analysis on FDA's Regulatory Protocols—Mike on Medtech

Mike Drues and Sean Fenske discuss what may be missing from the FDA’s regulatory oversight and opportunities they could offer.

By Sean Fenske, Editor-in-Chief02.08.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency’s regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:

  • Can you please take a minute to explain why we are dedicating an episode to what’s missing from regulatory and quality systems?
  • First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?
  • What about a catch-up 510k and letter to file pre-sub?
  • How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?
  • Let’s jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?
  • Staying in this realm, what about the idea of having substantial equivalence in the Class III and PMA realm?
  • What are today’s takeaways in what we may be missing in regulatory and quality systems?
Listen to this episode and see what you think of these regulatory ideas. 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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