Clinical Scorecard: FDA change plans in radiology AI

At a Glance

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

• Radiology: Artificial Intelligence