FDA Seeks Public Input on Generative AI Medical Device Regulation

The FDA's digital health center has issued a discussion paper on regulatory considerations for generative AI medical devices, seeking public feedback through October 19, 2026. The paper highlights the technology's transformative potential alongside distinct regulatory challenges.

2026-08-20 ~ 2026-08-22 · 2 related posts

• FDA seeks public comment until Oct 19 on regulating medical devices using generative AI — emmanuelvivier · 2026-08-20
• FDA seeks feedback on regulating generative AI-enabled medical devices in new discussion paper — emmanuelvivier · 2026-08-22