Article
FDA Seeks Public Feedback On Regulatory Approach For Generative AI-Enabled Medical Devices
The U.S. Food and Drug Administration has released a discussion paper outlining its initial framework for regulating generative AI-enabled medical devices, proposing a two-axis risk assessment approach and a novel competency-based premarket evaluation system. With public comments due by October 19, 2026, this represents a critical opportunity for device manufacturers and stakeholders to shape the regulatory landscape for this transformative technology.
Katten Muchin Rosenman LLP