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June 5, 2019

Statement Type Regulatory Comment
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In comments submitted this week to the U.S. Food and Drug Administration (FDA), the nation’s informatics professionals applauded the agency for developing a regulatory Modification Framework for Artificial Intelligence (AI)/Machine Learning (ML)-based software as a medical device (SaMD). The American Medical Informatics Association (AMIA) offered additional observations and recommendations for consideration in developing the framework further.