CPT 2027 Adds Ten AI Service Codes: What the AMA Release Means for AI/ML Device Developers
September 10, 2026
Focus area
AI/ML software as a medical device
Regulatory strategy for AI-enabled software, from intended use and device determination through FDA submission, PCCPs and post-market monitoring.
How we help
Intended use and pathway
Device determination, clinical decision support analysis, and whether 510(k) or De Novo fits.
Pre-Submissions
Questions, study design and algorithm descriptions that get useful FDA feedback before you commit.
Validation and submission
Performance testing strategy, software and cybersecurity documentation, and the eSTAR package.
PCCPs and lifecycle
Planned model updates, monitoring and change control that hold up after clearance.
