FDA Predetermined Change Control Plans for Radiology AI Surge in 2025, but Postmarket Monitoring Triggers Remain Undisclosed

Nearly one-third of FDA-cleared radiology AI devices involve Predetermined Change Control Plans, with 65% cleared in 2025 alone. However, a new analysis finds public summaries consistently omit performance monitoring metrics and drift-trigger thresholds needed for postmarket sur…

• Among all FDA-cleared AI/ML devices with a PCCP, 34 of 37 (91.9%) were for radiology, and 77.5% of all FDA-listed AI/ML submissions were radiological.
• Discrepancies between the FDA's public database and individual regulatory summaries required manual adjudication for 27% (9/34) of radiology PCCP devices.
• Documentation completeness scored a mean of 5 out of 8, with continuous performance monitoring and predefined retraining triggers absent from all public summaries.

Automated summary

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