Documentary record · October 19, 2026 edition
CDRH FY2027 guidance priorities posted
PRIORITY LIST — COMMENTS REQUESTED BY NOVEMBER 30, 2026
SOURCE-VERIFIED · HUMAN REVIEW PENDING
Event date
October 1, 2026
Lifecycle state
PRIORITY LIST — COMMENTS REQUESTED BY NOVEMBER 30, 2026 (docket FDA-2012-N-1021)
Source published
October 1, 2026
Source checked
October 19, 2026
Published on KPSGILL
A-list finals include:
- AI-enabled device software functions: marketing submissions and lifecycle management;
- Predetermined Change Control Plans;
- robotically-assisted surgical devices.
A-list draft: generative-AI conversational devices for mental disorders.
Under construction: generative-AI risk and evidentiary considerations.
Does not establish
that any listed guidance will issue in FY2027.
Sources
- CDRH FY2027 proposed guidances Primary · 2026-10-01 · checked 2026-10-19
Related on this site
Register: the record store · record id cdrh-fy2027-guidance-priorities-2026-10-01 · SOURCE-VERIFIED · HUMAN REVIEW PENDING.