November 3, 2025
Sarah Fitzgerald
Background and overview
The U.S. government’s 2026 fiscal year (FY) commenced on Oct. 1. To start things off, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has shared its updated plan for guidance documents. The plan is organized into three categories: A-List, B-List and Under Construction (UC).
A-List
Includes the highest priority documents, which the FDA intends to publish this year.
- There are eight guidance documents on this list.
- Of particular note, guidance related to software functions in medical devices and requirements for quality management system information in premarket submissions are likely to affect many manufacturers.
B-List
Includes guidance documents the agency plans to work on as time and resources allow.
- There are three guidance documents on this list.
- Of particular note, a guidance document on artificial intelligence-enabled software may provide significant clarity for this cutting-edge technology.
UC-List
Identifies guidance documents that the FDA intends to work on but are not on the A or B lists. This is generally understood to mean that these are a lower priority.
- There are nine guidance documents on this list.
- Of particular note, there are two guidance documents related to the intended use and one related to evaluating thermal effects that are likely to be broadly applicable.
Companies should be aware of potential pending changes that may affect their devices. If there is a topic that is likely to apply to your device, especially one that is in development, check the FDA website for updates to guidance documents regularly.
It is also important to note that the CDRH does not always follow its plan, so it is good regulatory practice for manufacturers to check this website periodically to stay informed of current FDA perspectives on relevant topics.
FDA CDRH priorities summary
The FDA CDRH lists from FY2025 and FY2026 are provided below, along with which list they were on by year and relevant notes:
| Guidance topic | FY2025 plan | FY2026 plan | Published in FY2025 and FY2026 |
|---|---|---|---|
| Third-party 510(k) and emergency use review | A-List: Final (Revision) | Final published FY2025 | |
| Enforcement policies during an emergency | A-List: Final Tests A-List: Final In Vitro Diagnostics (IVDs) | Final (IVDs) published FY2026 | |
| Cybersecurity and quality system considerations | A-List: Final | Final published FY2025 | |
| Laboratory-developed tests | A-List: Final | ||
| Pre-determined change control plans | A-List: Final (AI) | A-List: Final (General) | Final (AI) published FY2025 |
| Medical device shortages | A-List: Final | ||
| User fee waivers for small businesses undergoing financial hardship | A-List: Final | ||
| Q-submissions | A-List: Final (Revision) | Final published FY2025 | |
| Real-world evidence | A-List: Final (Revision) | A-List: Final | |
| Validation of diagnostic tests for emerging pathogens | A-List: Final | A-List: Final | Draft published FY2025 |
| Artificial intelligence (AI) lifecycle management | A-List: Draft | B-List: Final | Draft published FY2025 |
| Laboratory-developed tests for unmet needs | A-List: Draft | ||
| Labeling in vitro diagnostics | A-List: Draft | ||
| Software assurance for production and quality system software | B-List: Final | Final published FY2026 | |
| Device software functions | B-List: Draft | A-List: Draft | |
| Thermal effects evaluation | UC-List: Final | UC-List (not listed) | |
| Patient preference information | UC-List: Final | Draft published FY2025 | |
| Selecting a predicate device | UC-List: Final | UC-List (not listed) | |
| Expectations for 510(k) implant devices | UC-List: Final | UC-List (not listed) | |
| Clinical data Use in 510(k)s | UC-List: Final | UC-List (not listed) | |
| 3D printing medical devices at point of care | UC-List: Draft | ||
| Clinical evidence for digital mental health treatment devices | UC-List: Draft | UC-List (not listed) | |
| General and specific intended use | UC-List: Draft (Revision) | UC-List (not listed) | |
| Intended use for 510(k) devices and substantial equivalence with limitations | UC-List: Draft (Revision) | UC-List (not listed) | |
| Quality management system information for premarket submissions | A-List: Draft | Draft published FY2026 | |
| Patient preference information | A-List: Final | ||
| Weight loss medical devices | B-List: Final | ||
| Human factors content | B-List: Final | ||
| Mammography facility appeals | Final published FY2025 | ||
| Conducting decentralized clinical trials | Final published FY2025 | ||
| Chemical analysis for biocompatibility | Draft published FY2025 | ||
| The Accreditation Scheme for Conformity Assessment (ASCA) Program | Draft published FY2025 | ||
| ASCA for biocompatibility testing | Draft published FY2025 | ||
| ASCA for electrical safety | Draft published FY2025 | ||
| Neurodevelopmental safety studies in neonatal products | Final published FY2025 | ||
| Ethylene oxide sterilization transition transitional enforcement policy | Final published FY2025 | ||
| Global unique device identification database (GUDID) | Final published FY2025 | ||
| Clinical protocol deviations | Draft published FY2025 | ||
| Clinical evaluation of sex differences | Draft and Final published FY2025
| ||
| Communicating scientific information for unapproved uses | Final published FY2025 | ||
| Developing drugs for optical imaging | Draft published FY2025 | ||
| AI used to support regulatory decision-making | Draft published FY2025 | ||
| Notifying FDA of a discontinuance or interruption in manufacturing | Final published FY2025 | ||
| Modular review | Final published FY2025 | ||
| Institutional review board procedures | Final published FY2025 | ||
| Data standards catalog | Final published FY2025 | ||
| Electronic submission template for Q-submissions | Draft published FY2025 | ||
| Transfer of 510(k) clearances | Draft published FY2025 | ||
| Conducting remote regulatory assessments | Final published FY2025 | ||
| Unique device identifier (UDI) for combination products | Draft published FY2025 | ||
| User fee small business qualification and determination | Final published FY2025 | ||
| Fit-for-purpose clinical assessments | Final published FY2026 | ||
| Device-specific | A-List: Draft respirators A-List: Draft menstrual products A-List: Draft pulse oximeters UC-List: Final LASIK lasers | A-List: Draft respirators A-List: Draft menstrual products UC-List: Pulse oximeters UC-List: Robotically assisted surgical devices | Diagnostic x-ray equipment: Final published FY2025 Dental impression materials: Final published FY2025 Dental ceramics: Final published FY2025 Dental cements: Final published FY2025 Dental handpieces and motors: Final published FY2025 Dental implants and abutments: Final published FY2025 Non-spinal bone plates, screws and washers: Final published FY2025 Non-spinal metallic bone screws and washers: Final published FY2025 Pulse oximeters: Draft published FY2025 Hernia mesh: Draft published FY2025 Dental grafting material animal studies: Final published FY2025 Menstrual products: Draft published FY2026 |
Report on CDRH FY2025 plan versus publication
An evaluation of the published compared to the planned FY2025 CDRH list is provided in the table below:
| FDA CDRH priority list | FY2025 list | Published in FY2025 | Notes |
|---|---|---|---|
| A-List | 11 Final | 4 Final and 1 Draft | 2 additional final published FY2026 36% published as expected in FY2025 |
| 6 Draft | 2 Draft | 1 additional draft published in FY2026 33% published as expected in FY2025 | |
| B-List | 1 Final | 0 | 1 final published in FY2026 |
| 1 Draft | 0 | ||
| UC-List | 6 Final | 1 Draft | |
| 4 Draft | 0 | ||
| None | None (As needed) | 22 Final and 12 Draft |
The FDA CDRH published 34 (final and draft) guidance documents not specified in the CDRH FY2025 Plan. Of the planned 17 A-List guidance documents, only 6 were published in the format expected (35%) or 7 if you count a guidance that was expected to be finalized and instead a new draft version was published (41%). They also published 1 of the 12 that they planned to work on as resources permitted (B-List and UC-List).
Of particular note, thirty-four guidance documents were not specifically identified in the FDA’s original plan, representing 81% of all documents published that year. This underscores the importance of due diligence and ongoing monitoring to stay informed about new developments as they arise.
Concluding remarks
The U.S. FDA CDRH has published its Fiscal Year 2026 (FY2026) plan for updating guidance documents. Of particular note, as they are likely to be broadly applicable, guidance documents that they plan to update include guidance related to software functions in medical devices and requirements for quality management system information in premarket submissions. Additionally, if resources permit, they plan to update a guidance document on artificial intelligence-enabled software that may provide significant clarity for this cutting-edge technology, two guidance documents related to intended use, and one related to evaluating thermal effects that are likely to be broadly applicable.
Companies should be aware of potential pending changes that may affect their devices. If a topic is likely to apply to your device, especially one that is in development, you should regularly check the FDA website for updates to guidance documents.
It is also important to note that the CDRH does not always follow its plan, so all companies should check this website periodically to stay informed of current FDA perspectives on relevant topics. In FY2025, the FDA CDRH published 35% of the guidance documents that they planned to publish in the format that they expected (6 of 17), and 28% of guidance documents that they had noted they intended to work on, including those that would only be worked on as resources permitted (8 of 29). They also published 34 other guidance documents.
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