FDA prepares to regulate AI in medical devices

As medical devices are increasingly being touched by new AI innovations, the FDA will soon have to grapple with the reality of regulating “living things” in a new way, according to a report from Roll Call. Looking into the future, traditional means of regulation on medical devices won’t work for new inventions powered by AI.

Now, the FDA is currently evaluating an approach of evaluating medical device companies, including organizational culture of the maker, rather than simply the device or equipment. The FDA could assess machine learning practices, what data the AI systems are trained on and how algorithms are fine-tuned. The monitoring process and performance assessment would also be part of the picture.

However, the agency’s history with medical device regulation “has been found waiting” in some cases, according to the report. Fast-track approvals for some medical devices have come under fire after consumers reported injuries for breast implants, mesh and surgical staplers. On the flip side, changes to AI algorithms could potentially require FDA review under future requirements.

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