FDA and MHRA outline faster rules for generative AI medical devices

The U.S. Food and Drug Administration (FDA) expects to issue draft policy guidance for generative AI medical devices within months, according to Regulatory Focus. The policy will build on an August discussion paper that requested feedback on regulatory approaches for these devices.

The proposed framework would rely on nonclinical benchmarking and clinical confirmation to assess how devices perform. Rick Abramson, director of FDA's Digital Health Center of Excellence, said the agency has received hundreds of comments on the paper.

The Medicines and Healthcare products Regulatory Agency (MHRA) plans to issue guidance on predetermined change control plans at the end of the year. The guidance will go out in draft for public comment, said Jessica Paulsen, MHRA's deputy director for AI and software.

Both regulators are also weighing how real world data and monitoring after launch could support oversight across a product's lifecycle. MHRA is considering whether such monitoring could reduce some evidence requirements before approval.