Generative AI in Medical Devices: Explore 7 key questions shaping FDA regulatory expectations in 2026, from AI model validation and patient safety to human oversight and continuous monitoring. Key takeaways In August 2026, the FDA published a discussion paper on regulating generative AI medical devices and asked the industry for feedback. The paper is not guidance. It does not set new requirements, but it shows how the FDA is thinking. Seven themes run through it: risk, users