How the EU AI Act applies to AI-enabled medical devices after the 2026 Digital Omnibus: high-risk classification, Articles 9–17, MDCG 2025-6 and an integration plan.

FDA's Digital Health Center of Excellence has published a discussion paper on regulating generative AI-enabled medical devices, posing 26 detailed questions with a public comment docket open through October 19. What it signals about where FDA's thinking is headed, and how sponsors should respond.