US FDA CDRH Announces Guidance Document Priorities for Fiscal Year 2027

By Sarah Fitzgerald

Background and overview

The U.S. government fiscal year (FY) 2027 commenced Oct. 1. The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published its FY 2027 plan for updating guidance documents throughout the year. This consists of three lists: A-List, B-List and Under Construction (UC) List.

Summary of FY 2027 highest-priority A-List

The A-List includes the FDA’s highest-priority guidance documents, which it intends to publish this year. 

• There are eight guidance documents on this list, seven intended to be final and one intended to be draft. 
• Of particular note, guidance related to artificial intelligence (AI), predetermined change control plans (PCCPs) and the Accreditation Scheme for Conformity Assessment (ASCA) is likely to affect many manufacturers.
• Others are primarily device-type-specific.

Summary of FY 2027 moderate-priority B-List

The FDA intends to work on the B-List as resources permit.

• There are five guidance documents on this list, three intended to be final and two intended to be draft.
• Of particular note, guidance related to Q-Submissions, software functions and post-market cybersecurity management is likely to affect many manufacturers. 

Summary of FY 2027 UC List

The UC List identifies guidance documents that the FDA intends to work on but that are not on the A- or B-Lists. This is generally understood to mean that these are lower priority.

• There are four guidance documents on this list. 
• Of particular note, there are guidance documents related to selecting predicate devices for 510(k)s, evaluating substantial equivalence in 510(k)s and 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 their device, especially one that is in development, they 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 as part of regulatory intelligence practices, manufacturers should check this website periodically to monitor the FDA’s current perspective on relevant topics. 

Details and comparison to FY 2025 and FY 2026 plans and actual publication

The FDA CDRH lists from FY 2025, FY 2026 and FY 2027 are provided in the following table, along with the list of commitments and relevant notes. Note that this table only includes guidance documents that were on one of these priority lists — the FDA has released additional guidance documents not included in this table. Additionally, sometimes the FDA already has a version of the guidance document on the list, and including it indicates that the FDA intends to revise it rather than publish a completely new document. 

FDA CDRH priorities summary by FY

An evaluation of the published guidance documents compared to the planned FY 2025 and FY 2026 CDRH lists is provided in the following tables. 

Report of CDRH FY 2025 plan versus publication  

Report of CDRH FY 2026 plan versus publication 

Analysis of FY lists and publications

The FDA CDRH publishes guidance documents both on the priority lists and not on the lists. In FY 2025, CDRH published six of the 17 guidance documents on its A-List (35%). From the A-List, it published an additional draft that had been expected to be published as a final, as well as additional guidance documents in FY 2026. CDRH published one additional guidance document from the lower-priority lists out of the 12 CDRH intended to work on, for a total of eight guidance documents published from the priority lists. Additionally, CDRH published 34 guidance documents not included on its FY 2025 priority lists, representing 81% of the guidance documents published in FY 2025. Some of these additional guidance documents were cross-FDA-center documents and may not have been primarily worked on by CDRH.

In FY 2026, CDRH published five of the eight guidance documents on its A-List (63%). It also published three guidance documents from the lower-priority lists out of the 12 CDRH intended to work on, for a total of eight guidance documents published from the priority lists. Additionally, CDRH published 21 guidance documents not included on its FY 2026 priority lists, representing 72% of the guidance documents published in FY 2026. Some of these additional guidance documents were cross-FDA-center documents and may not have been primarily worked on by CDRH.

Concluding remarks

The U.S. FDA CDRH has published its FY 2027 plan for guidance documents. Some of these are broadly applicable, including those on the highest-priority list (A-List) related to AI, PCCPs and the ASCA program, and those on the lower-priority lists to be worked on as resources permit related to Q-Submissions, software functions, post-market cybersecurity management, selecting predicate devices for 510(k)s, evaluating substantial equivalence in 510(k)s and the evaluation of thermal effects. 

Companies should be aware of potential pending changes that may affect their devices and monitor the FDA website appropriately. The FDA publishes a significant number of guidance documents from the highest-priority A-List, 35% for FY 2025 and 63% for FY 2026. 

It is also important to note that CDRH does not always follow these lists, so all companies should check this website periodically to stay informed of current FDA perspectives on relevant topics. In both FY 2025 and FY 2026, the majority of guidance documents published were not on the priority lists (81% in FY 2025 and 72% in FY 2026). Some of these additional guidance documents were cross-FDA-center documents and may not have been primarily worked on by CDRH.

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