AI-enabled devices, predetermined change control plans and robotic surgery lead the FDA's medical device guidance agenda for the coming year. On 1 October 2026, the FDA's Center for Devices and Radiological Health (CDRH) published its lists of guidance documents planned for fiscal year 2027, which runs from October 2026 to September 2027.
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FDA Publishes Its Medical Device Guidance Priorities for Fiscal Year 2027
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The agenda is divided into three lists:
- A-list: priority guidance documents CDRH intends to publish during the fiscal year
- B-list: guidance documents CDRH intends to publish as resources permit
- "Under Construction" list: guidance documents CDRH intends to develop, but that are not yet on the A- or B-list
In total, the A- and B-lists contain 13 guidance topics. Stakeholders can comment on the lists until 30 November 2026.
The A-list: CDRH's priorities for FY2027
The A-list contains seven final guidance topics and one draft guidance. A final guidance is the definitive version that reflects the FDA's current thinking, while a draft guidance is first published for public comment.
Final guidance topics:
- Marketing Submission and Lifecycle Management Recommendations for Artificial Intelligence-Enabled Device Software Functions
- Predetermined Change Control Plans for Medical Devices
- Robotically-Assisted Surgical Devices – Premarket Submissions
- Quality Management System Information for Certain Premarket Application Reviews
- The Accreditation Scheme for Conformity Assessment (ASCA) Program guidances
- Menstrual Products: Performance Testing & Labeling Recommendations
- Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators
Draft guidance topic:
- Generative Artificial Intelligence-Enabled Conversational Devices for Mental Disorders: Evidentiary Recommendations
The final guidance on predetermined change control plans is particularly relevant: its title no longer refers only to AI-enabled devices, but to medical devices in general.
The B-list and the "Under Construction" list
The B-list includes three final and two draft guidance topics that CDRH plans to publish as resources permit:
- Final: Medical Device User Fee Small Business Qualification and Determination; Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; and Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Draft: Policy for Device Software Functions, and Postmarket Management of Cybersecurity in Medical Devices
The "Under Construction" list shows where the FDA's thinking is heading beyond the coming year. It includes guidance on selecting a predicate device for a 510(k) submission, select updates for evaluating substantial equivalence in the 510(k) program, risk assessment and evidentiary considerations for generative AI-enabled devices, and the evaluation of thermal effects of devices that heat or cool tissue.
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What this means for manufacturers
Software and AI remain the focus. Several of the priority topics address software, AI and cybersecurity across the device lifecycle, from premarket submissions to postmarket management. Manufacturers of software and AI-enabled devices should follow these documents closely, as they will shape how the FDA reviews such devices.
PCCPs are moving beyond AI. Predetermined change control plans allow manufacturers to agree on certain planned device changes with the FDA in advance. The planned final guidance covers medical devices in general, not only AI-enabled ones. This development is also reflected in the MDSAP Audit Approach: Revision 11, which applies to all MDSAP audits from 1 October 2026, removed the specific reference to AI-enabled devices for PCCPs, anticipating an FDA guidance that will extend them to other devices.
For manufacturers marketing devices in the United States, the Medical Device Single Audit Program (MDSAP) offers an efficient route: the FDA accepts MDSAP audit reports in place of its routine inspections.
Quality management and premarket reviews. With the FDA's Quality Management System Regulation (QMSR) in effect since February 2026, the planned final guidance on QMS information for certain premarket application reviews is relevant for any manufacturer preparing a premarket application.
Because the QMSR incorporates ISO 13485:2016 by reference, a certified ISO 13485 quality management system provides a strong foundation for the US market.
Cybersecurity in the postmarket phase. The draft guidance on postmarket management of cybersecurity is on the B-list. In parallel, Revision 11 of the MDSAP Audit Approach has already added FDA requirements for device cybersecurity and postmarket feedback to the audit tasks.
Intentions, not a fixed schedule. The lists show which guidance documents the FDA plans to publish, not a guaranteed timetable. In fiscal year 2026, CDRH published 7 of the 11 guidance documents on its list: five from the A-list and two from the B-list.
How to comment
CDRH welcomes comments on the lists until 30 November 2026, submitted via regulations.gov under docket number FDA-2012-N-1021. The FDA is particularly interested in feedback on the relative priority of the guidance topics, proposals for content to include, and suggestions for new guidance documents.
The full lists are available on the FDA website: CDRH Proposed Guidances for Fiscal Year 2027
Stay informed with DQS
As a Notified Body (NB 0297) and authorised MDSAP Auditing Organization, DQS is accredited to certify quality management systems according to ISO 13485, with accreditations from DAkkS in Germany and ANAB in the United States, among others. We support manufacturers in accessing the US, European and other international markets through ISO 13485, MDSAP and MDR certification.
To stay up to date on these topics, explore our training courses on AI-enabled devices, medical device software and MDSAP at the DQS Academy.
Developing AI-enabled devices? Find out where your organization stands with our ISO/IEC 42001 readiness checklist.
Author
Yuan Li, PhD
Dr. Yuan Li holds a doctorate in Mechanical Engineering and has published 13 studies on spinal pathologies and implant innovation. He built his career in Regulatory Affairs, guiding 510(k) and CE certifications across the U.S., EU, and APAC regions. Since joining the notified body sector in 2015, he has advanced from orthopedic product reviewer to management, now overseeing North American operations with a focus on market growth and compliance.
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