FDA Seeks Public Feedback on Regulatory Approach for Generative AI-Enabled Medical Devices

The FDA issued a discussion paper seeking public feedback on preliminary regulatory approaches for generative AI-enabled medical devices, focusing on risk assessment, premarket competency evaluation, and postmarket monitoring challenges. The FDA proposes a two-axis risk framework and a novel competency assessment for premarket evaluation, inviting industry input through October 19, 2026.

This Wire brief sits within Fusion42's coverage of Medtech, and 6 sources have reported it between 18 Aug 2026 and 21 Aug 2026.