October 2026: FDA Publishes FY 2027 Device Guidance Agenda; Artificial Intelligence Lifecycle and PCCP Draft Guidances Listed, Comments Due by November 30

FDA Publishes FY 2027 Device Guidance Agenda

October 20, 2026 — On October 1, 2026, the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) published three guidance document lists for fiscal year 2027: the A-list, the B-list, and the 'under development' list, totaling 17 items. The lists identify full lifecycle recommendations for artificial intelligence-enabled device software functions and predetermined change control plans (PCCPs) as draft guidance priorities. Manufacturers may submit comments on list priorities and content through regulations.gov until November 30, 2026.

Three Lists, 17 Items

The A-list sets out final guidances CDRH prioritizes for issuance during the fiscal year. The B-list identifies projects to be issued as resources permit. The 'under development' list identifies topics CDRH intends to begin drafting but has not yet scheduled. According to FDA Law Blog, the three lists total 17 items, down from 20 in FY 2026 and 29 in FY 2025.

CDRH clearly describes the nature of the lists on its page. Guidance documents represent the agency's current thinking and are not legally binding. The lists are work plans and do not guarantee that every item will be completed; the agency may also issue documents not on the lists. The lists can answer which issues FDA intends to clarify in the coming year, but they cannot answer when a particular requirement will take effect. These two questions are often confused.

Software and Artificial Intelligence Dominate the A-List

According to RAPS and FDA Law Blog reviews of the list items, the A-list priorities center on software and artificial intelligence. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations is listed as a draft guidance; its draft was issued in January 2025. The Predetermined Change Control Plans for Medical Devices draft guidance is also listed as a draft; its draft dates to August 2024. The lists also include quality system information for certain premarket submissions, the ASCA conformity assessment recognition program, premarket submissions for robotic-assisted surgical devices, and performance testing and labeling recommendations for menstrual products. According to RAPS, CDRH plans to issue 11 final guidances and 3 draft guidances this fiscal year, with 3 additional items on the under-development list.

New and Returning Topics

New topics also merit attention. At the draft level, the lists include Evidence Recommendations for Generative Artificial Intelligence-Enabled Conversational Devices for Psychiatric Disorders, and the renamed Device Software Functions Policy, formerly Device Software Functions and Mobile Medical Applications, which companies have often used to determine whether certain software falls within enforcement discretion. Postmarket cybersecurity also returns to the draft list. The under-development list includes considerations for selecting 510(k) predicates, an update to 510(k) substantial equivalence evaluation, and risk assessment and evidence considerations for generative artificial intelligence-enabled devices.

What the FY 2026 Record Shows

The completion rate of the lists provides a checkable reference. FDA's page states that of the 11 guidances on the FY 2026 list, 7 were actually issued, including 5 from the A-list and 2 from the B-list. This figure is more direct than any industry interpretation: inclusion on the A-list indicates high priority, not a guarantee of issuance within the year. When setting regulatory timelines, manufacturers should use the lists to judge direction and use issued documents to judge obligations; the two cannot substitute for each other.

Comment Window Open Until November 30, 2026

The comment window is the other half of the agenda. CDRH states that comments on the lists are due by November 30, 2026, and may be submitted through regulations.gov under Docket No. FDA-2012-N-1021, or by email to the CDRH guidance program. Comments may address the relative priority of list items, specific policies or data that should be included in a guidance, and reasons for adding, withdrawing, or consolidating a guidance. For companies preparing U.S. submissions, this is a low-cost and often overlooked channel.

Practical Implications for Regulatory Timelines

At the operational level, 510(k), De Novo, or PMA submissions already scheduled need not be revised merely because new topics appear on the lists; the lists do not change current review standards. However, if a product includes artificial intelligence functions or if a company plans to use a PCCP to support postmarket iterations, preparing lifecycle management, change descriptions, and monitoring metrics now on the assumption that final guidance may be stricter can substantially reduce rework. The list is a signpost, not a roadblock.

AIMEILI Regulatory Interpretation

For global manufacturers, distributors, CROs, and regulatory affairs teams, the FY 2027 agenda is primarily a planning signal. It does not create new legal obligations, but it indicates where FDA is likely to focus interpretive guidance and where submission expectations may become more detailed.

• Artificial intelligence lifecycle and PCCP finalization: Companies with artificial intelligence-enabled devices should prepare documentation that connects model development, training data, performance monitoring, change control, and marketing submissions. A PCCP should be treated as a lifecycle governance tool, not only a submission attachment.
• Shorter lists indicate prioritization: The reduction from 29 items in FY 2025 to 20 in FY 2026 and 17 in FY 2027 suggests tighter prioritization. A-list inclusion signals attention, but the FY 2026 record shows that final issuance is not assured.
• Comment opportunity: The November 30, 2026 deadline is relevant for companies with active artificial intelligence programs, generative artificial intelligence conversational devices, or PCCP strategies. Comments should be specific and supported by use cases, data, and implementation experience.
• 510(k) and cybersecurity topics: The under-development items on 510(k) predicate selection and substantial equivalence, together with the return of postmarket cybersecurity to the draft list, may affect long-term submission strategy. Current review standards remain in force until guidance is finalized.

Business Impact

• Submission timelines: Do not delay current 510(k), De Novo, or PMA filings solely because of the new agenda. Continue to rely on issued guidance and current review standards for filing decisions.
• Artificial intelligence documentation: Build traceability now across intended use, model updates, performance monitoring, labeling, and change protocols. This will reduce rework if final guidance adopts more detailed expectations.
• PCCP strategy: For products expected to undergo frequent software or model updates, assess whether a PCCP is appropriate and prepare a clear description of planned changes and associated risk controls.
• Regulatory intelligence: Track the finalization of the artificial intelligence lifecycle and PCCP guidances, the renamed device software functions policy, and the postmarket cybersecurity draft. Update regulatory intelligence and training materials accordingly.
• Market access planning: For distributors and CROs, the agenda can inform client timelines and gap assessments, especially for artificial intelligence-enabled products and software-intensive devices.

Sources

• U.S. Food and Drug Administration (CDRH) — CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), October 1, 2026.
• U.S. Food and Drug Administration — Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (draft guidance).
• U.S. Food and Drug Administration — Predetermined Change Control Plans for Medical Devices (draft guidance).
• Regulatory Affairs Professionals Society (RAPS) — FDA's device center releases guidance agenda for FY 2027, October 2, 2026.
• FDA Law Blog — CDRH's FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and Artificial Intelligence, October 18, 2026.

Source and scope note: This article is based on the FDA CDRH FY 2027 guidance list page published on October 1, 2026, which sets out the roles of the A-list, B-list, and under-development list, the statistic that 7 of 11 FY 2026 guidances were issued, and the November 30, 2026 comment deadline and Docket No. FDA-2012-N-1021. Specific list items are based on RAPS reporting dated October 2, 2026, and FDA Law Blog analysis dated October 18, 2026, as cited above; media reports were not relied on as the sole basis. The corresponding draft guidances are available in FDA's guidance database: the January 2025 artificial intelligence-enabled device software functions guidance and the August 2024 PCCP guidance. Verification was limited to the public pages cited above, accessed on October 20, 2026. Guidance documents are not legally binding, and list items may be adjusted, delayed, or canceled. This article does not constitute a conclusion on the regulatory pathway or classification of any specific product; manufacturers should assess based on their own products and submissions under review.