AMIA Supports, Encourages Further Refinement of FDA AI/Machine Learning Regulatory Framework

June 5, 2019

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.