FDA Publishes FY 2027 Device Guidance Agenda: 13 A/B Items, Comments Due November 30, 2026

FDA Publishes FY 2027 Device Guidance Agenda

On October 1, 2026, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) updated its medical device guidance agenda for fiscal year 2027. The webpage content update date is October 1, 2026, the first day of FY 2027. The agenda is divided into three tiers: an A list of guidances CDRH intends to prioritize during the fiscal year, a B list of guidances to be issued as resources permit, and an in-development tier for projects CDRH intends to start but does not place in the first two tiers. The A and B lists together contain 13 items, with 4 additional projects in development.

A List: Seven Final Guidances and One Draft

The A list contains seven final guidances and one draft guidance. The seven final items are:

• Certain NIOSH-approved air-purifying respirators: compliance policy for premarket and other requirements.
• Artificial intelligence-driven device software functions: recommendations for marketing applications and total product lifecycle management.
• Menstrual products: performance testing and labeling recommendations.
• Predetermined change control plans (PCCP) for devices.
• Quality management system information in certain premarket application reviews.
• Robotically assisted surgical devices: premarket submission recommendations.
• Accreditation Scheme for Conformity Assessment (ASCA): related guidance.

The sole A-list draft guidance is titled Generative Artificial Intelligence-Enabled Conversational Devices for Psychiatric Disorders: Evidence Recommendations. This item merits separate attention because it addresses clinical evidence expectations for generative artificial intelligence in psychiatric and psychological settings, rather than folding those issues into a broad artificial intelligence guidance.

B List and In-Development Projects

The B list contains three final guidances and two draft guidances. The three final items are:

• Small business qualification for medical device user fees.
• Medical pulse oximeters: nonclinical and clinical performance testing, labeling, and premarket submission recommendations.
• Feedback and meeting requests for premarket submissions, i.e., the Q-Submission Program.

The two B-list draft guidances are:

• Device Software Functions Policy, with the title changed from Device Software Functions and Mobile Medical Applications Policy.
• Postmarket management of device cybersecurity.

The in-development list contains four projects:

• Predicate device selection considerations to support 510(k) submissions.
• Thermal effects evaluation for devices that generate tissue heating or cooling.
• Risk assessment and evidence considerations for generative artificial intelligence-driven devices.
• Certain updates to 510(k) substantial equivalence determinations.

All four in-development items are marked as being developed as resources permit. Inclusion does not mean a draft will necessarily be issued in the current fiscal year.

Comment Window Closes November 30, 2026

CDRH welcomes comments on the agenda as a whole or on any specific guidance. The deadline is November 30, 2026. Electronic submissions may be filed through regulations.gov under Docket No. FDA-2012-N-1021, and comments may also be sent at any time to CDRH-Guidance@fda.hhs.gov. FDA states that it is interested in three types of input: the relative priority of A-list versus B-list items; specific policies or information that should be included in a particular guidance; and reasons for adding or withdrawing a guidance. If a party recommends withdrawing or modifying an existing guidance, it should provide both the rationale and specific proposed changes.

Such comments are not a formality. The A/B ranking is itself a resource-allocation decision. Which guidance is issued first and which is deferred directly affects the basis on which companies prepare materials over the next one to two years.

FY 2026 Completion Rate as a Benchmark

The same FDA page reports FY 2026 results: the list contained 11 items, of which 7 were published, including 5 A-list items and 2 B-list items. The finalization commitment is that, within three years after the comment period on a draft ends, 80% of drafts will be finalized, withdrawn, have their comment period reopened, or be replaced by a new draft; within five years, the figure is 100%. Among the FY 2016 to FY 2022 data listed on the page, FY 2022 shows all 15 drafts addressed within three years. Two drafts issued before October 2020 remain without any action.

The practical use of these figures is direct: treat the A list as high probability, the B list as possible, and the in-development list as a watch list. Internal planning should not assume that every listed item is about to be published.

Guidance Is Not Regulation and Creates No New Obligations

The boundary should be stated clearly. Under U.S. law, guidance documents do not create legal obligations, as expressly provided in 21 CFR 10.115. Placement on the A list neither guarantees publication on schedule nor means that a guidance will have binding force on the day it is published. True mandatory requirements come from statutes and regulations; guidance explains FDA’s current review thinking.

The correct reading of this agenda is therefore forward-looking intelligence, not a compliance countdown. It indicates where CDRH intends to allocate review resources over the next twelve months and which technical areas are moving from individual case review toward written policy.

AIMEILI Regulatory Interpretation and Business Impact

For global manufacturers, distributors, CROs, and regulatory affairs teams, the FY 2027 agenda is a planning signal for evidence generation, submission sequencing, and comment strategy. It should not be treated as a list of immediate legal requirements, but it can help teams anticipate where FDA review expectations may become more explicit.

Planning Priorities

• A-list items: treat these as high-probability planning assumptions for the next twelve months, especially where they affect active premarket programs.
• B-list items: monitor closely but avoid committing launch or filing timelines solely on the assumption that a draft or final guidance will be issued on schedule.
• In-development items: use these as a watch list for policy direction, particularly for 510(k) predicate selection, substantial equivalence, thermal effects, and generative artificial intelligence-driven devices.

Artificial Intelligence, Digital Health, and Clinical Evidence

The A-list final guidance on artificial intelligence-driven device software functions and the A-list draft guidance on generative artificial intelligence-enabled conversational devices for psychiatric disorders may significantly influence premarket evidence expectations, lifecycle management, and PCCP strategy. Companies with digital health, software as a medical device, or artificial intelligence-enabled products should review their clinical validation, risk management, human factors, cybersecurity, and postmarket performance monitoring plans against these developing expectations. The separate draft on psychiatric conversational devices signals that FDA may expect tailored evidence for generative artificial intelligence in mental health applications rather than generic software evidence.

Submission and Compliance Readiness

• PCCP: assess whether current or planned devices would benefit from a predetermined change control plan, and align change-control documentation with evolving expectations.
• QMS information in premarket reviews: prepare quality management system information that can be efficiently presented in premarket submissions.
• ASCA: consider whether conformity assessment accreditation can support testing and review efficiency for applicable devices.
• Pulse oximeters, menstrual products, and robotic-assisted surgical devices: review performance testing, labeling, and submission strategies for consistency with anticipated FDA recommendations.
• Cybersecurity: strengthen postmarket cybersecurity monitoring, vulnerability management, and complaint handling, as FDA plans a B-list draft on postmarket cybersecurity management.

510(k) Strategy and Predicate Selection

The in-development projects on predicate device selection and substantial equivalence updates are relevant to 510(k) strategy. Although these projects are not guaranteed for FY 2027, they indicate that FDA may provide more structured expectations for predicate selection and equivalence analysis. Companies should document predicate rationale, intended use comparisons, technological differences, and performance testing decisions in a way that can withstand greater scrutiny. Existing 510(k) programs should not be delayed solely because these projects are in development, but regulatory teams should monitor them for future submission planning.

Comment Strategy

The November 30, 2026 comment deadline offers a direct opportunity to influence CDRH priorities and guidance content. Companies and trade associations with significant pipeline exposure should consider submitting targeted comments that identify specific guidance items, explain the business and public health impact, and propose concrete policy language or evidence expectations. Comments are most useful when they address relative A/B priority, specific content for a particular guidance, or a clear rationale for adding or withdrawing an item.

Commercial and Market-Access Implications

Distributors and market-access teams should note that guidance developments in cybersecurity, pulse oximetry, menstrual products, and robotic-assisted surgery may affect labeling, postmarket obligations, and customer due diligence. CROs should prepare to support sponsors with updated evidence strategies, particularly for artificial intelligence-enabled devices and 510(k) equivalence assessments. Across all product lines, the agenda is best used to prioritize regulatory intelligence and resource planning rather than to trigger immediate compliance actions.

Sources

U.S. Food and Drug Administration (CDRH), CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), page content updated October 1, 2026: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2027-fy-2027

U.S. Food and Drug Administration (CDRH), CDRH Proposed Guidances for Fiscal Year 2027 (PDF), October 1, 2026: https://www.fda.gov/media/195054/download

This article interprets public regulatory planning information and does not constitute a conclusion or commitment for any specific product, company, or registration application. List items may be added, removed, adjusted, or delayed; the official FDA guidance as published controls.