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    FDA’s Steps Toward a new Review Framework for Medical Devices Using Artificial Intelligence Algorithms

    This article provides a high-level overview of FDA’s proposed framework specifically tailored to promote the development of medical devices using artificial intelligence algorithms; it is not intended to provide a detailed explanation of the proposal, which is very technical.   Introduction   On 2 April 2019, the Food and Drug Administration (FDA) issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to pro...