Predetermined Change Control Plan Adoption and Documentation Transparency in U.S. Food and Drug Administration-cleared Radiology Artificial Intelligence/Machine Learning Devices.
PMID: 42524710 ·
Ketan Dayma, Palak Patel, Kenneth Hildreth, Tamara Jamaspishvili
JournalRadiology. Artificial intelligence
Year
PMID42524710
Abstract
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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