FDA Guidance on Artificial Intelligence (AI) in Medical Devices

July 20, 2023


In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." 

In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what FDA's guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!

Listen now:

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Some of the highlights of this episode include:

  • What artificial intelligence means in software as a medical device (SaMD)
  • Why this new FDA draft guidance is needed
  • Recommendations for medical device companies on what this draft guidance provides
  • Challenges with validating the modifications for an ML-DSF
  • What specific items to include in a PCCP
  • Whether a PCCP potentially impacts the future need of a Letter to File or new 510(k) and what would necessitate an additional market submission


Memorable quotes from Mike Drues:

"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike Drues



About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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