Evaluating Transparency of Predetermined Change Control Plans in FDA-Cleared Radiology AI Devices: A Systematic Scoping Review
Abstract
Importance: Adoption of FDA-cleared AI/ML-enabled devices is rising, led by Radiology, and FDA is adapting to a newer framework of Predetermined Change Control Plan (PCCP) to enable controlled post-market modification without separate application, yet there is limited public transparency on how updates are planned, documented, and monitored.Objective To characterize PCCP adoption and documentation transparency among FDA-cleared radiology AI/ML devices.Design and Setting: Cross-sectional systematic scoping review (PRISMA-ScR; PROSPERO 1180559) using linked data from the FDA AI/ML-enabled device list, public 510(k), De Novo, and PMA databases through April 2026. PCCP documentation completeness was scored using an 8-point rubric derived from FDA's final PCCP submission guidance (December 2024).Main Outcomes and Measures: Regulatory pathway distribution, sequential 510(k) update patterns, PCCP adoption rates across AI versus non-AI FDA panels, and PCCP documentation completeness across eight transparency domains in radiology-AI devices.Results Among 1,394 FDA-listed AI/ML-enabled device submissions, 1080 (77.5%, 870 unique devices) were radiology submissions, nearly all cleared via 510(k). Across all FDA panels, 170 devices were PCCP-cleared; radiology led AI/ML-specific PCCP adoption at 91.2% (34/37 radiology PCCP devices), while cardiology's apparent lead dissolved to only 23.1% (9/39) once non-AI hardware devices were separated. Of 34 PCCP-cleared radiology AI devices, 65% (22/34) cleared in 2025 alone following final FDA guidance. Discrepancies between FDA's public database and individual summaries required manual adjudication for 27% of devices (9/34). Two devices were inadvertently cleared for PCCP, later corrected. One device cleared for PCCP, has no description of PCCP. PCCP documentation scores ranged from 0–8 (mean 5), with most modifications focused on data retraining, compatibility expansion and algorithm optimization. Continuous monitoring of device performance and predefined drift triggers for re-training were absent from public summaries. Public documentation completeness varied substantially, and data harmonization challenges complicated systematic evaluation.Conclusion and Relevance : PCCP adoption is accelerating in Radiology, yet public lifecycle controls, particularly monitoring metrics and trigger thresholds, remain sparse. Standardized PCCP reporting is essential for systematic post-market monitoring. Importantly, these findings indicate that pending petitions to exempt CAD devices from premarket notification would exacerbate surveillance gaps until mandatory public disclosure of performance metrics is established.
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Citation Information
@article{ketandayma2026,
title={Evaluating Transparency of Predetermined Change Control Plans in FDA-Cleared Radiology AI Devices: A Systematic Scoping Review},
author={Ketan Dayma and Palak Patel and Kenneth Hildreth and Tamara Jamaspishvili},
journal={Research Square},
year={2026},
doi={https://doi.org/10.21203/rs.3.rs-9411603/v1}
}
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