Most manufacturers of medical devices with artificial intelligence (AI) features are not using predetermined change control plans (PCCPs) to manage changes throughout the device's lifecycle, representing a "missed opportunity" to improve device performance, according to a recent research letter published in JAMA Health Forum.
Patryk Dabek of the Washington University School of Medicine in St. Louis and colleagues conducted a study evaluating PCCP use among AI-enabled medical devices and evaluated the information in existing PCCPs for these devices between 2023 and 2025.
In December 2024, FDA issued final guidance on PCCPs for AI/ML software products. The guidance discusses how sponsors can proactively plan product updates without filing new premarket applications for certain product changes (RELATED: Final FDA guidance on PCCP includes clarification on version control, Regulatory Focus 3 December 2024).
Using FDA databases, the researchers identified 794 AI-enabled medical devices authorized from 2023 to 2025; just 43 (5.4%) had FDA-authorized PCCPs, with the first being granted in the third quarter of 2023.
The authors also evaluated four key aspects of each authorized PCCP: modification list, modification protocols, notification plan, and impact assessment, finding that 90% of PCCPs reported a modification list, 83% reported a modification protocol, 74% reported a notification plan, and 72% noted an impact assessment. Overall, 72% reported all four FDA-recommended elements.
For devices with a notification plan, 70% used changes to labeling or instructions for use, 33% used interface notifications, 30% used direct correspondence, and 18% used release notes. Over half (55%) used two or more methods.
“PCCPs allow manufacturers to quickly implement device modifications while prespecifying plans for mitigating risk. As such, low PCCP use may represent a missed opportunity for improving device performance,” the authors wrote, noting that the PCCP authorization process was generally accessible to manufacturers with differing levels of experience. “Nonetheless, low overall adoption indicates that there remain unidentified barriers to PCCP use.”