Study finds low PCCP utilization among AI-enabled devices
Study finds low PCCP utilization among AI-enabled devices
https://www.raps.org/resource/study-finds-low-pccp-utilization-among-ai-enabled-devices.html
Publish Date: 2026-05-29 10:41:00
Source Domain: www.raps.org
- Most manufacturers of AI-enabled medical devices are not using predetermined change control plans (PCCPs) to manage changes throughout the device’s lifecycle, according to a study published in JAMA Health Forum.
- From 2023 to 2025, out of 794 AI-enabled medical devices reviewed, only 5.4% (43 devices) had FDA-authorized PCCPs.
- The FDA issued final guidance on PCCPs for AI/ML software products in December 2024, focusing on proactive planning for product updates without new premarket applications.
- Only 72% of the authorized PCCPs included all four key elements recommended by the FDA: modification list, modification protocols, notification plan, and impact assessment.
- The low adoption of PCCPs suggests a “missed opportunity” to improve device performance, as these plans can help mitigate risk and allow for quick implementation of modifications.
- Identified barriers to the use of PCCPs remain unidentified despite the process being generally accessible to manufacturers of varying experience levels.
