The US Food and Drug Administration (FDA) has opened public consultations on a new proposed framework to regulate generative artificial intelligence (GenAI) in medical devices. Unlike standard medical software, GenAI tools carry unique risks—such as generating false outputs or "hallucinations"—that require a novel, clinician-style competency assessment rather than traditional static testing. The FDA is collecting global feedback from health experts and technology developers through October 19 to help set a safe standard for AI-driven patient care.
🔗 Read the full update: [FDA Official Release on GenAI Medical Devices]( https://www.fda.gov/news-events/press-announcements/fda-seeks-public-feedback-inform-regulatory-approach-generative-ai-enabled-medical-devices )