On 18 August 2026, the FDA’s CDRH published “Considerations for the Regulation of Generative AI-Enabled Medical Devices”, a discussion paper with an open request for feedback.

As acknowledged by the FDA, whilst GenAI-enabled medical devices have the potential to improve patient outcomes, they come with their own set of risks and challenges currently unaddressed by existing policies for software-based devices including those enabled by predictive AI.

The discussion paper is the next logical step for the FDA after the November 2024 public advisory committee meeting, during which total product lifecycle considerations for GenAI-enabled devices were discussed.

In our 5-minute guide below, our Head of Regulatory Richie Christian outlines the scope of the discussion paper, highlights five key components and insights, and looks ahead to next steps.

You can read the guide in the viewer or download at the button – and should you have a regulatory challenge related to your AI-enabled medical device, get in touch with our experts.