product3 distinct publishers
FDA's generative-AI device rulebook is still a draft, and the comment docket shuts October 19
The agency floated doctor-style competency testing for GenAI medical devices and said the graded object is the shipped product, not the model underneath. Comments close October 19, 2026.
Perspective Coverage
3 publishers- Builder
- Builder 35%
- Operator
- Operator 40%
- Investor
- Investor 25%
Reality
- Evidence88
- Adoption14
- Hype gap+16