FDA’s FY2027 Device Roadmap: AI, 510(k), QMS and Predicate Selection Are Moving
The FDA’s Center for Devices and Radiological Health (CDRH) has released its proposed guidance agenda for Fiscal Year 2027, offering an important look at the areas the agency intends to prioritize in medical device regulation and review.
The agenda does not create new regulatory requirements. Rather, it identifies guidance documents that CDRH intends to publish or develop during FY2027. Because guidance documents reflect the FDA’s current thinking on regulatory issues, however, the agenda can provide useful insight into where regulatory expectations may evolve.
What is on FDA’s FY2027 priority list?
Several areas stand out from the A-list of guidance topics CDRH intends to prioritize.
AI-enabled device software functionsCDRH plans to issue guidance addressing marketing submission and lifecycle management recommendations for AI-enabled device software functions.
Predetermined Change Control Plans (PCCP)PCCP remains a major focus as the FDA continues to develop regulatory approaches for devices that may undergo planned changes after authorization.
Quality Management System information in premarket reviewsCDRH also plans to finalize guidance addressing QMS information for certain premarket application reviews, reinforcing the connection between quality systems and premarket regulatory evaluation.
Robotically-Assisted Surgical DevicesPremarket submission recommendations for robotically-assisted surgical devices are also included among the FY2027 priorities.
The A-list also includes guidance related to menstrual products and the ASCA program, while a draft guidance on Generative AI-enabled conversational devices for mental disorders is also listed as a priority.
The 510(k) signal may be even more important
Perhaps one of the most notable parts of the FY2027 agenda is found under “Under Construction.”
CDRH identifies the following topics for future development:
Considerations for Selecting a Predicate Device to Support a 510(k) Submission
Select Updates for the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
Risk Assessment and Evidentiary Considerations for Generative AI-Enabled Devices
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling
The first two deserve particular attention.
Predicate selection and substantial equivalence are fundamental to the 510(k) pathway. FDA has already been working to modernize this area, including a 2023 draft guidance on best practices for selecting predicate devices. That draft was explicitly described as not for implementation and containing non-binding recommendations.
The FY2027 agenda therefore does not mean that manufacturers must immediately change their 510(k) strategy.
It does, however, suggest that how manufacturers select predicates and establish substantial equivalence will remain an area of regulatory attention.
What does this mean for medical device manufacturers?
For companies developing or planning to submit devices in the next several years, particularly:
510(k) devices
AI-enabled devices and SaMD
software-heavy medical devices
surgical robotics
novel devices
devices relying on complex predicate strategies
the regulatory environment should be monitored beyond the requirements that exist today.
For a project expected to continue into 2027, manufacturers may want to monitor developments across five connected areas:
Predicate selection → Substantial equivalence → AI lifecycle/PCCP → QMS information → Premarket evidence
The key is not to react to a guidance agenda as if it were a new requirement.
Instead, it is to understand what the FDA is signaling about the direction of future regulatory thinking—and determine whether that direction could affect a device already in development.
Regulatory Intelligence Matters Before the Guidance Is Final
FDA guidance development is not static. CDRH notes that guidance topics may be modified, removed, reprioritized, or affected by new priorities and public feedback. The agency is also currently accepting comments on the FY2027 guidance lists through November 30, 2026.
For medical device companies, therefore, regulatory strategy should not begin only when a final guidance is published.
Understanding the direction of FDA policy development can provide valuable context while a device is still in the design, evidence-generation, or submission-planning stage.
The FY2027 agenda is not a new rulebook. It is a roadmap—and for companies with 2027 regulatory milestones, it is a roadmap worth watching.
