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FDA Device Center Puts AI, Change-Control Plans and Surgical Robots Atop FY 2027 Guidance List

CDRH's annual lists name the guidance documents it intends to publish this fiscal year, and comments on the priorities are open until November 30.

By News DeskOctober 2, 20262 min read
Exterior of FDA Building 64, a laboratory building on the White Oak campus
FDA Building 64 on the agency's White Oak campus in Silver Spring, Maryland, which houses laboratories for CDER and CDRH. U.S. Food and Drug Administration, public domain, via Wikimedia Commons · Public domain (U.S. government work)

Key points

  • CDRH published its proposed guidance lists for fiscal year 2027 on October 1, 2026, split into an A-list of priorities, a B-list to be published as resources permit and an Under Construction list.
  • A-list items include final guidance on AI-enabled device software functions, predetermined change control plans and robotically-assisted surgical devices, plus a draft on generative AI conversational devices for mental disorders.
  • The center is taking comments on the lists until November 30, 2026, under docket FDA-2012-N-1021, according to RAPS.

The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has published the guidance documents it plans to prioritize in fiscal year 2027, with final guidance on artificial intelligence-enabled device software and on predetermined change control plans at the top of the list.

The FDA's FY 2027 page sorts the documents into three lists. The A-list identifies the priority guidance documents CDRH intends to publish during the fiscal year; the B-list covers documents it intends to publish as resources permit; and an Under Construction list names guidance CDRH intends to develop as resources permit that is not on either of the first two lists. The center said it welcomes comments on any of the listed documents by November 30, 2026.

The priority list

According to RAPS, which reported that CDRH announced the lists on October 1, the A-list's final guidance topics are:

  • Marketing submission and lifecycle management recommendations for AI-enabled device software functions, finalizing a draft issued in January 2025.
  • Predetermined change control plans, which let manufacturers implement certain pre-specified device changes without a new submission, finalizing a draft issued in August 2024.
  • Premarket submissions for robotically-assisted surgical devices, finalizing a draft the FDA issued in September 2026.
  • A compliance policy for certain NIOSH-approved air-purifying respirators.
  • Performance testing and labeling recommendations for menstrual products.
  • Quality management system information for certain premarket application reviews.
  • Guidance for the Accreditation Scheme for Conformity Assessment (ASCA) program.

The A-list also includes one new draft: evidentiary recommendations for generative AI-enabled conversational devices intended for mental disorders, RAPS reported.

Lower-priority and future work

The B-list includes final guidance on small business qualification for medical device user fees, performance testing and labeling for pulse oximeters, and the Q-Submission program for feedback and meetings, along with two drafts, on policy for device software functions and on postmarket management of cybersecurity in medical devices, according to RAPS.

Four topics sit on the Under Construction list: selecting a predicate device for a 510(k) premarket notification, evaluating thermal effects of devices that heat or cool tissue, risk assessment for generative AI-enabled devices, and updates to the 510(k) substantial equivalence guidance, RAPS reported.

RAPS said CDRH is seeking feedback on how it has prioritized the A- and B-lists and on whether additional guidance is needed. Comments go to docket FDA-2012-N-1021. Guidance documents describe the FDA's current thinking and are generally not legally binding.

Sources

  1. CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), U.S. Food and Drug Administration, October 1, 2026
  2. FDA's device center releases guidance agenda for FY 2027, RAPS Regulatory Focus, October 2, 2026