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The US, UK, and Canada recently released five guiding principles for predetermined change control plans (PCCPs) in machine learning-enabled medical devices. This builds upon the 2021 joint document identifying 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP). The quality support that principles such as those outlined in the GMLP Guiding Principles uphold enable patient benefits like earlier access to innovative technologies and more accurate diagnosis. Change management helps ensure continued safety and effectiveness of devices throughout the total product lifecycle (TPLC).
