AI Predetermined Change Control Plan—Mike on Medtech

AI Predetermined Change Control Plan—Mike on Medtech

Mike Drues and Sean Fenske discuss an FDA guidance that would outline how AI or ML technologies could be allowed to evolve without new submissions.

By Sean Fenske, Editor-in-Chief09.19.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:

  • Can you please give a brief overview of what an AI or ML product is?
  • Can you explain how this product can, quote evolve, as the FDA puts it?
  • Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?
  • So why is this important? Why is it important to enable an AI or ML device to evolve?
  • Can you offer real world examples of how this all works?
  • What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.

Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. 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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