FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

摘要

On April 2, 2019, the U.S. Food and Drug Administration (FDA or Agency) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a medical device. FDA's "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD): Discussion Paper and Request for Feedback"' (Discussion Paper) attempts to address the challenging and unique features of AI/ ML-based SaMD products, including the capability of such products to continuously learn (i.e. "train") from real-world feedback, adapt, and modify output when used for diagnostic or therapeutic purposes.