If you buy AI-powered medical devices: the FDA's big rulebook for them is still in draft
The FDA has authorized over a thousand AI-enabled medical devices, but its first comprehensive rulebook for how these devices should be designed, validated, and monitored over their whole life — published as a draft in January 2025 — has still not been finalized. Why a hospital should care: once final, it will shape what documentation and ongoing performance monitoring you can demand from device vendors, especially for AI tools whose behavior changes with updates. Reasonable ask of vendors today: whether they're already building to the draft guidance rather than waiting.
Primary source: FDA AI-Enabled Device Software Functions (draft) — fda.gov