FDA Seeks Public Feedback On Regulatory Approach For Generative AI-Enabled Medical Devices

The FDA issued a discussion paper seeking public feedback on regulatory approaches for generative AI-enabled medical devices, proposing a risk-based framework and new premarket and postmarket evaluation models.

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