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

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.

Corresponding Author: Alexander O. Everhart, PhD, Division of General Medicine and Geriatrics, John T. Milliken Department of Medicine, Washington University in St Louis School of Medicine, 660 S Euclid Ave, MSC 8121-022-07, St Louis, MO 63116 (everhart@wustl.edu).

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