#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Description

In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device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 this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!

Questions Asked

1. What does artificial intelligence mean in software as a medical device
2. Why is this new draft guidance needed?
3. What recommendation for medical device companies does the draft guidance provide?
4. What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)
5. What are some of the specific items a PCCP should include?
6. Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?

Quotes

"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

Reference Links

• Draft FDA Guidance
• Etienne Nichols
• Greenlight Guru