FDA Device Guidance Agenda: Key Regulatory Updates for 2026
Decision brief
Answer first · skim in under a minute
The FDA's device guidance agenda for 2026 is set to bring significant regulatory updates. This article outlines key takeaways and implications for the pharmaceutical sector.
FDA’s device guidance agenda for 2026 is the CDRH FY2026 A-list, B-list, and Under Construction list—not a rumor mill. Priority final topics center on real-world evidence, predetermined change control plans, emerging-pathogen diagnostics, and patient preference, while AI-enabled device lifecycle guidance sits on the B-list after CDRH published 11 of 15 FY2025 planned guidances.
Contents9 sections
Key Takeaways
- CDRH posted FY2026 proposed guidance lists with an A-list (priority), B-list (as resources permit), and Under Construction list.
- FY2025 delivery: 11 of 15 listed guidances published (10 A-list, 1 B-list); four LDT/IVD A-list items were dropped.
- A-list final topics include RWE for devices, PCCPs for medical devices, section 564 emerging-pathogen diagnostic validation, and patient preference information.
- Stakeholder comments on the FY2026 lists were requested by December 1, 2025, under docket FDA-2012-N-1021.
What is CDRH’s FY2026 device guidance agenda structure?
Each fiscal year (October 1 to September 30), CDRH identifies guidances it intends to publish or develop. The A-list marks priority publications for FY2026. The B-list covers additional publications if resources allow. The Under Construction list, used since FY2025, flags earlier-stage development topics outside A/B.
CDRH notes it is not obligated to issue every listed document if public-health priorities intervene, and it may issue unlisted guidances when needed.
Source: FDA: CDRH Proposed Guidances for Fiscal Year 2026; FDA: CDRH Proposed Guidance Development.
Which A-list and B-list topics matter for 2026 planning?
According to the FY2026 PDF, A-list final guidance topics include validation of diagnostic tests for emerging pathogens after a section 564 declaration, use of real-world evidence to support device regulatory decisions, predetermined change control plans for medical devices, and incorporating voluntary patient preference information over the total product life cycle.
A-list draft topics include NIOSH-approved air-purifying respirator enforcement discretion, menstrual products labeling and performance testing, quality management system information for certain premarket reviews, and policy for device software functions.
- A-list finals: RWE, PCCPs, section 564 diagnostics, patient preference
- B-list finals: AI-enabled device lifecycle recommendations; weight-loss indication devices; human factors content in marketing submissions
- FY2025 published: 11 of 15 planned guidances
Source: CDRH Proposed Guidances for Fiscal Year 2026 (PDF).
What did FY2025 delivery reveal about agenda credibility?
CDRH reported publishing 11 of 15 guidances on the FY2025 list—10 from the A-list and 1 from the B-list. It stopped four A-list LDT/IVD projects: special-controls enforcement discretion for LDTs, unmet-needs LDT FAQ enforcement discretion, IVD labeling, and IVD emergency public-health-response enforcement policy absent a section 564 declaration.
For draft-guidance hygiene, CDRH restates MDUFA-aligned goals to act on 80% of drafts within three years and 100% within five years of comment-period close, as resources permit. For FY2026 it will strive to finalize, withdraw, or reopen comment for 50% of existing draft guidances issued before October 1, 2020.
Source: FDA FY2026 proposed guidances page (FY2025 metrics).
Implications for device and combination-product teams
Align 2026 filing calendars to A-list finals first—especially PCCP and RWE expectations that change how iterative software and evidence packages are built. Treat B-list AI lifecycle guidance as likely but not guaranteed for FY2026 issuance timing.
Under Construction items such as predicate selection best practices, 510(k) implant evidentiary expectations, and pulse oximeter evidence revisions signal where CDRH may later tighten substantial-equivalence narratives.
Related coverage: FDA AI guidance, FDA animal testing alternatives blueprint, and FDA exclusivity guidance.
What remains unproven
Appearance on the A-list is an intent statement, not a publication date. CDRH may delay, retitle, or drop topics, as it did with four FY2025 LDT/IVD items. Teams should not assume B-list AI lifecycle finalization will land in FY2026 solely because it is listed.
Related NovaPharma coverage
- FDA AI guidance: risk-based approach
- FDA blueprint on animal testing alternatives
- FDA clarifies 3-year exclusivity guidance
Frequently Asked Questions
What is on CDRH’s FY2026 A-list of device guidances?
A-list final topics include validation of diagnostic tests for emerging pathogens under section 564, use of real-world evidence for medical devices, predetermined change control plans for medical devices, and incorporating voluntary patient preference information over the total product life cycle.
How many FY2025 CDRH guidances were published?
CDRH published 11 of 15 guidances on the FY2025 list (10 from the A-list and 1 from the B-list) and decided not to pursue four A-list LDT/IVD enforcement and labeling topics.
Is AI device lifecycle guidance on the FY2026 priority A-list?
No. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Marketing Submission Recommendations appears on the FY2026 B-list of final guidance topics, meaning CDRH intends to publish as resources permit.
Primary Sources
Sources & references 1 primary sources
Sources verified at publication. See our editorial policy and data sources.
This article follows our editorial standards. Report a correction via editorial contact.
