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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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学術誌Radiology. Artificial intelligence

年2026

PMID42524710

抄録

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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