CDRH Proposed Guidances for Fiscal Year 2026 (FY2026)
The FDA’s Center for Devices and Radiological Health (CDRH) is sharing lists of guidance documents that 1) we intend to publish in fiscal year 2026 (FY 2026), or 2) we intend to develop.
This information is provided in the following lists:
- The A-list: Identifies the priority guidance documents CDRH intends to publish during FY 2026.
- The B-list: Identifies the guidance documents CDRH intends to publish as resources permit during FY 2026.
- “Under Construction” list: Identifies guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.
A-List, B-List, and Under Construction List
- CDRH Proposed Guidances for Fiscal Year 2026 [PDF - 87 KB]
How to comment on these guidance lists or a specific guidance
CDRH appreciates comments on any of the guidance documents on the lists by December 1, 2025.
Submit electronic comments to www.regulations.gov. Received comments will reside in the docket and, except for those submitted as "Confidential Submissions," will be publicly viewable at www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the document "Notice to Public of Website Location of CDRH Fiscal Year 2026 Proposed Guidance Development " located on www.regulations.gov under docket number FDA-2012-N-1021.
Specifically, CDRH is seeking comments on the relative priority of guidance documents on the A-list and B-list, as well as proposed policy or information for the FDA to consider for inclusion in these guidances. CDRH also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.
If a recommendation is made to withdraw or request a modification to an existing guidance document, CDRH requests that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.
CDRH also welcomes any additional feedback for improving the guidance program and the quality of guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that stakeholder needs are met. Comments and suggestions can also be emailed at any time to the CDRH Guidance Program.
Metrics for FY 2025 A-list and B-list Publication
Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2025 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2025, CDRH published 11 of 15 guidances on the FY 2025 list (10 from the A-list, 1 from the B-list). CDRH has decided not to pursue the development of four guidances on the A-list:
- Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls
- Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question
- In Vitro Diagnostics: Labeling
- Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
Metrics for the Finalization of Draft Guidance Documents
CDRH has committed to finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit. The percentage of draft guidances issued FY 2016 onward for which CDRH has taken an action within 3 years or within 5 years of the comment period close is as follows:
| Fiscal Year | Action taken within 3 years | Action taken within 5 years |
|---|---|---|
| FY 2016 | 23 of 29 (79%) | 25 of 29 (86%) |
| FY 2017 | 6 of 6 (100%) | 6 of 6 (100%) |
| FY 2018 | 22 of 24 (92%) | 23 of 24 (96%) |
| FY 2019 | 23 of 25 (92%) | 24 of 25 (96%) |
| FY 2020 | 9 of 10 (90%) | 10 of 10 (100%) |
| FY 2021 | 9 of 9 (100%) | 9 of 9 (100%) |
| FY 2022 | 14 of 15 (93%) | 5 years not yet reached |
In addition, in FY 2025, 2 draft guidances issued prior to October 1, 2019, remain for which no action has been taken yet, and CDRH has been continuing to work towards taking an action on these remaining draft guidances. Looking forward, in FY 2026, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2020.
Applicability of Previously Issued Final Guidance
In FY 2025, CDRH received comments regarding guidances issued in 2015, 2005, 1995 and 1985 and the revision of several guidance documents are being considered and pursued as resources permit. Two guidances that no longer reflect the FDA’s current thinking were withdrawn.