The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA

AI/ML-driven medical devices face increased regulatory complexity, prompting the U.S. FDA, Health Canada, and the U.K.’s MHRA to outline 10 guiding principles for Good Machine Learning Practices (GMLP). These principles aim to address challenges in data security, patient safety, and device quality, offering comprehensive guidelines for manufacturers. Ranging from leveraging multidisciplinary expertise and implementing robust software practices to ensuring representativeness of patient populations, maintaining independent data sets, and monitoring post-deployment models, these principles cover various facets of AI/ML device development. They emphasize compliance, clinical relevance, user transparency, and continuous monitoring for safety and performance.