FDA Regulation of Medical Devices
FDA Regulation of Medical Devices Judith A. Johnson Specialist in Biomedical Policy September 14, 2016 Congressional Research Service 7-5700 www.crs.gov
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The 21st Century Cures Act (12/13/2016) amended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions, including some described in this guidance ...