FDA seeks input on proposed regulatory approach to GenAI-based medtech

The FDA has released a 30-page discussion paper outlining a proposed regulatory approach for generative AI-enabled medical devices and is soliciting feedback until mid-October 2026 to shape a framework prioritising patient safety and innovation.

This Wire brief sits within Fusion42's coverage of Medtech, and 12 sources have reported it between 18 Aug 2026 and 19 Aug 2026.