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FDA releases 'guiding principles' for AI/ML device development

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The U.S. Food and Drug Administration released a list of "guiding principles" this week aimed at helping promote the safe and effective development of medical devices that use artificial intelligence and machine learning. The FDA, along with its U.K. and Canadian counterparts, said the principles are intended to lay the foundation for Good Machine Learning Practice. "As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards," said the agency regarding the principles. As the FDA notes, AI and ML technologies have the potential to radically expand the healthcare industry – but their complexity also presents unique considerations. The 10 guiding principles identify points at which international standards organizations and other collaborative bodies, including the International Medical Device Regulators Forum, could work to advance GMLP.