FDA seeks public feedback on regulating generative AI medical devices

The U.S. FDA has released a discussion paper inviting public feedback to shape regulatory frameworks for generative AI-enabled medical devices, focusing on risk assessment, premarket evaluation, and postmarket monitoring to ensure patient safety and innovation.

This Wire brief sits within Fusion42's coverage of Digital Health, and 14 sources have reported it between 18 Aug 2026 and 15 Sep 2026.