FDA seeks feedback on generative AI regulations

The FDA's Center for Devices and Radiological Health has issued a discussion paper seeking feedback on a potential regulatory framework for generative AI in medical devices, focusing on risk classification, premarket competency evaluations, and postmarket monitoring.

This Wire brief sits within Fusion42's coverage of Medtech, and 19 sources have reported it between 18 Aug 2026 and 18 Sep 2026.