Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices

Patryk A Dabek, Florence T Bourgeois, Ariel D Stern, Yi Zhu, Alexander O Everhart
JAMA Health Forum. 2026 May 1;7(5):e261204. doi: 10.1001/jamahealthforum.2026.1204.
Summary
This cross-sectional study describes predetermined change control plan use among artificial intelligence (AI)�enabled medical devices and the comprehensiveness of public reporting documenting predetermined change control plans.