Predetermined Change Control Plan Adoption and Documentation Transparency in U.S. Food and Drug Administration-cleared Radiology Artificial Intelligence/Machine Learning Devices.
PMID: 42524710 · 2026
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Purpose To characterize adoption of Predetermined Change Control Plan (PCCP) and documentation transparency among U.S. Food and Drug Administration (FDA)-cleared radiology artificial intelligence (AI)/machine learning (ML) devices (2015-2025). Materials and Methods A cross-sectional systematic scoping review was conducted with linked data from FDA AI/ML-enabled device databases through April 2026. Completeness of PCCP documentation was scored by two independent observers (intraclass correlation
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