FDA opens public consultation on AI-enabled medical devices

The U.S. Food and Drug Administration has launched a public consultation to develop a new regulatory framework for artificial intelligence-enabled medical devices. The move addresses concerns that generative AI could produce errors affecting clinical decisions and patient safety. The FDA said it intends to set rules for evaluating the devices before market release and monitoring their performance after deployment. The proposals include classifying devices by risk level, requiring accuracy and safety testing, and measuring their ability to respond across different medical conditions. Devices would also be reassessed regularly following updates. The agency set October 19, 2026, as the deadline for public comments. The framework is expected to shape oversight of medical AI technologies in the United States and internationally.