The FDA’s Center for Devices and Radiological Health (CDRH) published its proposed CDRH guidance list for fiscal year 2027 on October 1, 2026. The list names 17 guidance topics across three tiers. Artificial intelligence, software, and the 510(k) pathway stand out as the main themes. CDRH is accepting comments on the list until November 30, 2026.
Six of the 17 topics deal directly with AI or software. In addition, two guidances in development would revisit core parts of the 510(k) process. Below, we explain what is on the CDRH guidance list, what it could mean for your company, and how to comment.
How the CDRH Guidance List Is Organized
Each year, CDRH publishes its FDA guidance agenda in three parts. The A-list covers the guidances CDRH intends to publish as a priority during FY 2027. The B-list covers guidances it intends to publish as resources permit. Finally, the Under Construction list covers guidances CDRH plans to develop that are not on the A-list or B-list.
In practice, the tier signals how likely a guidance is to appear this year. However, the list is a statement of intent, not a commitment. In FY 2026, CDRH published 7 of the 11 guidances on its list, including 5 from the A-list and 2 from the B-list.
A-List Priorities: AI, QMS, Surgical Robotics, and More
The A-list includes seven final guidance topics. For AI developers, the most relevant is the final guidance on marketing submission and lifecycle management recommendations for AI-enabled device software functions. Once published, it is expected to clarify what FDA wants to see across an AI device’s lifecycle. The A-list also includes final guidance on predetermined change control plans (PCCPs) for medical devices. A PCCP lets a manufacturer describe planned device changes in advance. As a result, certain changes made under an authorized plan may not need a new marketing submission.
The remaining A-list final topics cover quality management system (QMS) information for certain premarket application reviews and robotically-assisted surgical devices. They also cover the Accreditation Scheme for Conformity Assessment (ASCA) Program and performance testing and labelling for menstrual products. Finally, CDRH plans a compliance policy for certain NIOSH-approved air-purifying respirators.
The A-list’s only draft guidance covers generative AI-enabled conversational devices for mental disorders. It would set out evidentiary recommendations for that device category. This follows FDA’s earlier request for feedback on generative AI medical devices, which we covered in August.
B-List and Software Policy Updates
The B-list includes three final guidance topics. The first covers small business qualification and determination for medical device user fees. The second covers testing, labelling, and premarket submission recommendations for pulse oximeters. The third covers the Q-Submission Program, which manufacturers use to request FDA feedback and meetings. If you are planning a Q-Sub or applying for small business status, these are worth following. For current fee amounts, see our summary of FDA’s medical device user fee rates for FY 2027.
The B-list also includes two draft guidances, and both affect software developers. The first is the Policy for Device Software Functions. Its title no longer includes “Mobile Medical Applications,” which may signal a change in scope. The second covers postmarket management of cybersecurity in medical devices. If your company develops software as a medical device (SaMD), both documents are relevant.
Under Construction: 510(k) Pathway Updates on the Horizon
The Under Construction list includes four topics. Two of them could reach most of the device industry. One covers how to select a predicate device for a 510(k) submission. The other covers how FDA evaluates substantial equivalence in 510(k) premarket notifications. Together, they address the two central steps in a 510(k) submission.
The other two topics cover thermal effects in devices that heat or cool tissue, and risk assessment for generative AI-enabled devices. The generative AI item suggests CDRH may develop a broader framework for that technology. For background on FDA’s recent direction, see our coverage of FDA’s 2026 AI medical device guidance.
Comment Deadline and How to Participate
CDRH is accepting comments on the FY 2027 list until November 30, 2026. You can submit electronic comments to docket FDA-2012-N-1021 on regulations.gov. Comments are public unless you submit them as confidential. You can also email comments to CDRH-Guidance@fda.hhs.gov.
CDRH is asking for input on four areas. These include the relative priority of A-list and B-list topics and what each guidance should include. CDRH also wants suggestions for new guidance, along with existing guidance that should be withdrawn or revised. For withdrawals or revisions, it asks you to explain why and suggest changes. The full list is available on FDA’s CDRH proposed guidances page and in the FY 2027 guidance list (PDF).
What This Means for Your Business
The CDRH guidance list shows where FDA medical device guidance is heading in the year ahead. If your company makes AI-enabled devices, the A-list guidances on AI lifecycle management and PCCPs need the closest attention. Both are priorities, so they are the most likely to be published in FY 2027. The QMS guidance is also worth watching. FDA’s Quality Management System Regulation (QMSR) has been in effect since February 2, 2026. Our guide on building a medical device QMS that meets FDA QMSR requirements is a useful starting point.
If you plan to file a 510(k) in the next year or two, keep an eye on the predicate and substantial equivalence topics. They are still in development, so they do not change current expectations. Even so, early drafts would show how FDA’s thinking is evolving. Our overview of 510(k) pre-submission steps can help you plan.
The comment period is also a chance to shape the agenda. If unclear guidance has affected your submissions, a specific comment can help bring that gap to CDRH’s attention. If you manage both PMA and 510(k) products, our PMA consulting team can help you plan across both pathways.
Key Takeaways
- CDRH published its FY 2027 guidance list on October 1, 2026, with 17 topics across the A-list, B-list, and Under Construction list.
- Six of the 17 topics address AI or software, making them the main theme of the CDRH guidance agenda.
- A-list final guidances include AI lifecycle management, PCCPs, QMS information, and robotically-assisted surgical devices.
- Two Under Construction topics cover 510(k) predicate selection and substantial equivalence.
- You can comment through docket FDA-2012-N-1021 on regulations.gov or by email until November 30, 2026.
Frequently Asked Questions
What is the difference between the CDRH A-list, B-list, and Under Construction list?
The A-list covers guidances CDRH intends to publish as a priority during FY 2027. The B-list covers guidances it intends to publish as resources permit. The Under Construction list covers guidances CDRH plans to develop that are not on either list. In FY 2026, CDRH published 5 A-list guidances and 2 B-list guidances.
Will the Under Construction 510(k) guidances affect pending submissions?
Not yet. The predicate selection and substantial equivalence guidances are not drafts, so they carry no current expectations. Once a draft is published, it will show the direction FDA intends to take. If you have a 510(k) in preparation, it is worth following CDRH updates on both topics.
What is CDRH asking for in the FY 2027 comment process?
CDRH wants input on the relative priority of A-list and B-list topics and on what each guidance should include. It also welcomes suggestions for new guidance and for existing guidance to withdraw or revise. Specific comments based on real submission experience are the most useful. Comments sent to docket FDA-2012-N-1021 are public unless marked confidential.
Does the generative AI draft guidance apply to all AI-enabled devices?
No. The A-list draft applies to generative AI-enabled conversational devices for mental disorders. The final guidance on AI-enabled device software functions applies more broadly. In addition, the Under Construction item on generative AI risk assessment may lead to a wider framework. We recommend tracking each document separately.
Preparing for the FY 2027 CDRH Guidance Agenda
The FY 2027 CDRH guidance list puts AI, software, and the 510(k) pathway at the centre of FDA’s device agenda. If your company has AI-enabled products, software functions, or upcoming 510(k) submissions, the list is worth a close review. You can also decide whether to comment by November 30, 2026. Our FDA medical device compliance team can help you understand how these guidances apply to your products. To discuss your plans, reach out to our team.
