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

The FDA's Center for Devices and Radiological Health is seeking public feedback on a regulatory framework for generative AI-enabled medical devices, addressing risk assessment, premarket evaluation, and postmarket monitoring specific to the unique challenges these devices present.

This Wire brief sits within Fusion42's coverage of Medtech, and 16 sources have reported it between 18 Aug 2026 and 2 Sep 2026.