FDA Publishes FY2027 Device Guidance Agenda: A List, B List and Under Construction List, Comments Due November 30

FDA Publishes FY2027 Device Guidance Agenda: A/B Lists and Under Construction List, Comments Due November 30

Published on October 6, 2026, 09:31 | Category: Guidance and Technical

On October 1, 2026, the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) published its list of guidances it intends to issue in Fiscal Year 2027 (FY2027). That date was the first day of FY2027. The list is divided into three parts: the A List contains the highest-priority guidances that CDRH plans to issue during the fiscal year; the B List contains guidances that CDRH intends to issue as resources permit; and a separate "Under Construction" list identifies topics CDRH intends to begin developing as resources permit but that are not included on either the A List or the B List.

It is important to be clear that these three lists describe what CDRH intends to do, not requirements that are already in effect. As CDRH states on its page, these are lists of guidances proposed for issuance or proposed for development. Companies should not treat the topics on the list as compliance obligations that have already taken effect, nor should they infer from the list that the review pathway for a particular product has already changed.

CDRH has also opened a comment window. Comments on the list itself or on any individual guidance on it may be submitted at www.regulations.gov no later than November 30, 2026. CDRH states that it is particularly interested in comments on the prioritization of the A List and B List, and on policy or information that commenters recommend be included in those guidances. CDRH also welcomes suggestions for new or different guidance topics, provided that the rationale is explained. If a commenter recommends withdrawing or revising an existing guidance, the comment should include both the rationale and the direction of the proposed changes. The related notice is filed under Docket FDA-2012-N-1021. In addition to regulations.gov, comments may be sent at any time to CDRH-Guidance@fda.hhs.gov.

The page also reports on performance for the previous fiscal year. The FY2026 list contained 11 guidances, of which CDRH actually issued 7: 5 from the A List and 2 from the B List. These figures indicate that a gap remains between the published list and actual output: a topic that appears on the list will not necessarily be issued within the fiscal year.

Regarding the disposition of draft guidances, CDRH has made a public, quantified commitment. Within 3 years after the close of the comment period, CDRH will finalize, withdraw, reopen the comment period for, or issue a new draft of 80% of draft guidances; within 5 years, it will do so for 100%. The year-by-year figures shown on the page indicate that for FY2016, 23 of 29 draft guidances (79%) were dispositioned, and for FY2022, 15 of 15 (100%) were dispositioned. In addition, 2 drafts issued before October 1, 2020 remained pending as of FY2026.

For companies active in the U.S. market, the appropriate use of this list is for planning, not as an endorsement. Companies can compare it against their own product lines and technology direction to assess where review expectations may change over the coming year. For topics that are covered, preparing nonclinical, clinical or software-related evidence in advance is more efficient than reworking submissions after a guidance is finalized. If a proposed guidance is directly relevant to a company's product, submitting comments through the docket before November 30 is low-cost and places the company's position into the rulemaking record.

AIMEILI Regulatory Interpretation

The FY2027 CDRH proposed guidance list is a planning instrument, not a change in regulatory requirements. Its legal effect is prospective and non-binding: inclusion of a topic on the A List, B List or Under Construction list does not create new obligations, does not alter the applicable premarket review pathway, and does not establish a presumption of clearance or approval. For regulatory affairs teams, the list should be read as an indicator of where CDRH intends to direct its policy development resources, not as a substitute for currently effective guidance, the applicable statute, or the relevant regulation.

Three structural features matter most. First, the A List represents the highest-priority topics CDRH plans to issue within FY2027, and it therefore carries the strongest signal of near-term policy movement. Second, the B List signals topics that may advance only if resources allow, so timing is less predictable. Third, the Under Construction list signals topics that CDRH intends to begin developing but that are not currently scheduled for issuance; these are best treated as early-warning items rather than as near-term changes.

The FY2026 performance data provide a useful calibration point. Of 11 listed guidances, 7 were issued, including 5 from the A List and 2 from the B List. This supports a practical planning assumption that A List topics have the highest probability of issuance within the fiscal year, while B List topics are less certain. Any internal timeline that assumes all listed topics will be issued should be treated as optimistic.

The draft guidance disposition commitment is also relevant to submission strategy. The stated measure is that, within 3 years after the close of a comment period, 80% of draft guidances will be finalized, withdrawn, reopened for comment, or replaced by a new draft, and that within 5 years, 100% will be dispositioned. Reported results of 23 of 29 (79%) for FY2016 and 15 of 15 (100%) for FY2022 indicate that the commitment is broadly, though not uniformly, met. The fact that 2 drafts issued before October 1, 2020 remained pending in FY2026 shows that a small number of legacy drafts can remain unresolved for extended periods. Companies should therefore avoid relying on an unresolved draft as the sole basis for a design or submission decision where an alternative, more stable basis exists.

The comment mechanism is a genuine, if limited, opportunity for influence. Comments may address prioritization of the A List and B List, recommend policy or information to be included, propose new or different topics with rationale, or recommend withdrawal or revision of an existing guidance with supporting reasoning and direction. The deadline of November 30, 2026 and Docket FDA-2012-N-1021 are the operative procedural details. Because comments are placed into the public record, submissions should be drafted with the expectation that they will be publicly visible and may be cited in later CDRH documents. Submissions should focus on technical, clinical, scientific or regulatory rationale rather than commercial positioning, and should avoid disclosing confidential business information.

Business Impact

For medical device manufacturers, the primary impact is on planning rather than on immediate compliance. The FY2027 list allows companies to map expected CDRH policy activity against their own product pipelines and technology platforms, particularly in areas where a guidance topic overlaps with an active development program. Where a topic on the A List is directly relevant, it is reasonable to begin aligning internal documentation, study designs and software lifecycle records with the direction implied by the topic, while keeping in mind that the guidance is not yet effective.

For submissions already in preparation, the practical risk is timing mismatch. If a relevant draft guidance is finalized or revised mid-review, additional information may be requested, and the evidentiary burden may shift. Early preparation of nonclinical, clinical, human factors, software and cybersecurity evidence is generally less costly than post hoc remediation, provided that the preparation is proportionate and does not pre-empt the final content of the guidance.

For distributors and regulatory affairs teams supporting U.S. market access, the list is a useful input into portfolio-level risk assessment and into communication with manufacturers regarding expected review expectations. It should not be presented to commercial partners as evidence that a particular requirement has changed or that a specific product will be reviewed differently.

For CROs and consultancies, the list supports service planning: topics on the A List are more likely to generate near-term demand for gap assessments, protocol alignment and dossier updates, while B List and Under Construction topics represent longer-horizon preparation. Commenting on behalf of clients is possible in principle, but any submission should be prepared and authorized in accordance with the client's instructions and with applicable disclosure considerations.

A final practical point concerns documentation discipline. Because the lists describe intent rather than obligations, internal records should clearly distinguish between current requirements, draft guidances and proposed topics. Where a company chooses to act on a proposed topic, the rationale and the basis for that decision should be documented, so that the decision can be revisited if the final guidance differs.

Sources and Applicability

Sources: U.S. Food and Drug Administration, CDRH page "CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027)," published 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 New - News and Updates," with the October 1, 2026 entry listing the FY2027 list: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-updates

U.S. Regulations.gov, Docket FDA-2012-N-1021 (comment submission portal): https://www.regulations.gov/docket/FDA-2012-N-1021

U.S. Food and Drug Administration, "CDRH Proposed Guidance Development" page (prior-year lists and performance metrics): https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development

Verification scope and access date: the FDA FY2027 proposed guidances page, the CDRH New updates list, the regulations.gov docket page and the CDRH guidance development page were reviewed for this article. Access date: October 6, 2026. The publication date, comment deadline and FY2026 issuance figures cited above are taken from those official pages.

Applicability: this article is an interpretation of publicly available regulatory information. It does not constitute a conclusion or commitment regarding any specific product, company or registration application, and it does not constitute legal advice. List contents, dates and metrics may change with subsequent official updates; the official source texts should be relied upon.

Information Sources

• U.S. Food and Drug Administration (FDA) - CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), 2026-10-01
• U.S. Food and Drug Administration (FDA) - CDRH New: News and Updates
• U.S. Regulations.gov - Docket FDA-2012-N-1021
• U.S. Food and Drug Administration (FDA) - CDRH Proposed Guidance Development