CDRH published its fiscal 2027 guidance agenda on October 1. The A-list carries 11 final guidances and three drafts. Comments are due November 30, 2026, under docket FDA-2012-N-1021.
Finalizing the January 2025 draft on lifecycle management for AI-enabled device software functions sits at the top. Predetermined change control plans carry over from last year. The robotically assisted surgical device draft FDA published in September is also on the A-list, with feedback due November 24. A new draft will set evidence expectations for generative AI conversational devices aimed at mental disorders.
Postmarket cybersecurity management, pulse oximeter performance testing, Q-Submission feedback and small business user fees all landed on the B-list. Four more documents sit in a third tier marked under construction, among them predicate device selection and substantial equivalence assessment.
The A-list is what CDRH commits to, and the B-list is what it reaches if the year cooperates. Anyone whose submission strategy depends on predicate selection or substantial equivalence policy should read that third tier as a warning that those answers are not arriving in 2027.