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 5 sources have reported it between 18 Aug 2026 and 21 Aug 2026.