Clinical Report: FDA Change Plans in Radiology AI

Overview

The adoption of Predetermined Change Control Plans (PCCPs) has increased among FDA-cleared radiology AI devices following new FDA guidance.

Background

The integration of artificial intelligence (AI) in radiology is rapidly evolving. The FDA's introduction of PCCPs aims to enhance the oversight of AI/ML devices, particularly in the context of continuous performance monitoring.

Data Highlights

Key Findings

• 1,394 FDA-listed AI/ML submissions were evaluated, with 1,080 (78%) in radiology.
• 130 (15%) of 870 unique radiology devices underwent sequential 510(k) clearances.
• The mean interval between sequential submissions decreased from 25 months to 13 months post-2021.
• Public documentation had a mean score of 5 on an 8-point rubric assessing transparency.
• Only 3 devices provided details on postmarket surveillance in public summaries.
• Documentation scores improved from 4 in 2024 to 5 in 2025, but completeness did not differ significantly before and after guidance.

Clinical Implications

Healthcare professionals should be aware of the increasing adoption of PCCPs in radiology AI devices.

Conclusion

The findings indicate a growing trend in the adoption of PCCPs among radiology AI devices.

Related Resources & Content

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3. European Radiology — A Comprehensive Guide to the Role of Artificial Intelligence in Thoracic Imaging: Insights from the European Society of Thoracic Imaging (ESTI)
4. Journal of Medical Internet Research (JMIR) — Patients’ Perspectives on the Implementation of AI in Radiological Diagnostics: Focus Group Study
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7. A Comprehensive Guide to the Role of Artificial Intelligence in Thoracic Imaging: Insights from the European Society of Thoracic Imaging (ESTI)
8. Patients’ Perspectives on the Implementation of AI in Radiological Diagnostics: Focus Group Study
9. ACR Approves First Practice Parameter for Imaging Artificial Intelligence
10. Predetermined Change Control Plan Adoption and Documentation Transparency in U.S. Food and Drug Administration-cleared Radiology Artificial Intelligence/Machine Learning Devices.
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