CDRH FY 2027 guidance list targets AI device software and 510(k) reform

The CDRH FY 2027 guidance list was published on October 1, 2026. It outlines the guidance documents that the FDA’s Center for Devices and Radiological Health plans to issue in fiscal year 2027, as well as those still in development. CDRH has split the items into an A-list, a B-list and an Under Construction list. The center is accepting comments on the priorities for the first two lists through November 30, 2026.

CDRH is looking for more than simple approval of the topics. Commenters can propose specific policy points or data for inclusion in each guidance. They can also suggest topics missing from the lists and explain why new guidance is warranted. If a commenter thinks an existing guidance should be withdrawn or updated, CDRH wants details on the reasons and, where relevant, the proposed changes.

The list comes with performance data from the prior year. In fiscal year 2026, CDRH issued 7 of the 11 guidances it had targeted, including 5 from the A-list and 2 from the B-list.

Ad

A-list: AI device software, change control plans and surgical robots

The A-list carries seven final guidance topics. Two of them address artificial intelligence and software directly: marketing submission and lifecycle management recommendations for artificial intelligence-enabled device software functions, and predetermined change control plans for medical devices.

Robotically-assisted surgical devices appear under premarket submissions, alongside quality management system information for certain premarket application reviews. The remaining final topics cover performance testing and labeling recommendations for menstrual products, compliance policy on premarket and other requirements for certain NIOSH approved air-purifying respirators, and the Accreditation Scheme for Conformity Assessment (ASCA) program.

One draft guidance sits on the A-list. It covers generative artificial intelligence-enabled conversational devices for mental disorders, with evidentiary recommendations.

B-list: user fees, pulse oximeters and the Q-Submission program

Three final guidance topics sit on the B-list. One concerns medical device user fee small business qualification and determination. Another sets out non-clinical and clinical performance testing, labeling and premarket submission recommendations for pulse oximeters for medical purposes. The third revisits requests for feedback and meetings for medical device submissions, known as the Q-Submission program.

Two draft topics complete the B-list. The first is a policy for device software functions, where CDRH notes the title has changed from “Policy for Device Software Functions and Mobile Medical Applications”. The second is postmarket management of cybersecurity in medical devices.

Under construction: 510(k) predicate selection and thermal effects

Four topics sit on the Under Construction list, which covers documents CDRH intends to develop. Two of them touch the 510(k) pathway: considerations for selecting a predicate device to support a premarket notification [510(k)] submission, and select updates for the 510(k) program on evaluating substantial equivalence in premarket notifications [510(k)].

The same list carries an evaluation of thermal effects of medical devices that produce tissue heating and/or cooling, and risk assessment and evidentiary considerations for generative artificial intelligence-enabled devices.

The record on finalizing draft guidances

CDRH has committed to finalize, withdraw, reopen the comment period or issue a new draft guidance for 80% of draft guidance documents within three years of the close of the comment period, and 100% within five years of the close of the comment period, as resources permit. The published figures for drafts issued from fiscal year 2016 onward show the commitment met or exceeded in each year reported.

Source: CDRH, as published with the FY 2027 proposed guidance lists.

Two draft guidances issued before October 1, 2020 remained without action in fiscal year 2026, and CDRH says it has been working toward taking an action on them.

Source: CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), FDA, content current as of October 1, 2026.