Predetermined Change Control Plan Adoption and Documentation Transparency in U.S. Food and Drug...

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 coefficient, 0.93) using an eight-point rubric (possible scores, 0-8) derived from the FDA's final PCCP guidance (December 2024). Identified PCCP devices underwent manual verification against FDA regulatory summaries. Results Among FDA-listed AI/ML device submissions, 1080 of 1394 (77.5%) were radiology submissions, and nearly all cleared via 510(k) review. Across all FDA panels, 170 devices were cleared with a PCCP. Radiology led AI/ML-specific PCCP adoption (34 of 37 radiology PCCP devices [91.9%]). Among the PCCP-cleared radiology AI devices, 22 of 34 (65%) were cleared in 2025 alone following the final FDA guidance. Discrepancies between the FDA's public database and individual summaries required manual adjudication for nine of 34 (27%) devices. PCCP documentation scores ranged from 0 to 8 (mean, 5), with most modifications focused on data retraining, compatibility expansion, and algorithm optimization. Continuous monitoring of device performance and predefined drift triggers for retraining were absent from public summaries. Conclusion PCCP adoption increased in radiology after issuance of the final FDA guidance, yet public lifecycle controls, particularly monitoring performance metrics and trigger thresholds, were limited. Standardized PCCP reporting of lifecycle controls are suggested as a condition of PCCP authorization to enable systematic postmarket monitoring as this pathway scales. Keywords: Health Policy and Practice, Informatics, Computer Aided Diagnosis (CAD), QA/QC, Safety, Technical Aspects, Legal Issues, Application Domain Supplemental material is available for this article. © RSNA, 2026 See also commentary by Sihlahla in this issue.