FDA change plans in radiology AI
Investigators examined adoption and public documentation of change control plans for FDA-cleared radiology AI devices.
By
Kathryn Wighton
September 16, 2026
Clinical Scorecard: FDA change plans in radiology AI
At a Glance
Category Detail
Condition Radiology artificial intelligence-enabled devices Key Mechanisms Predetermined Change Control Plans (PCCPs) Target Population Radiology professionals and AI/ML device manufacturers Care Setting Regulatory evaluation of AI/ML devices in radiology
Key Highlights
Adoption of PCCPs increased among radiology AI/ML devices post FDA guidance. 78% of FDA-listed AI/ML submissions were in radiology. Mean documentation scores for public summaries improved from 4 in 2024 to 5 in 2025. Only 3 devices provided details on postmarket surveillance. Manual corrections were needed for 9 of 34 PCCP-cleared devices. Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Public summaries for devices should include postmarket performance monitoring details. Risks
Limitations include database inconsistencies and lack of access to internal safety assessments. Patient & Prescribing Data
Not applicable as the study focuses on regulatory aspects.
No specific treatment insights provided.
Clinical Best Practices
Ensure transparency in documentation for AI/ML device performance. Adopt clear modification protocols for device changes. Related Resources & Content
