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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 R42130 FDA Regulation of Medical Devices Congressional Research Service Summary Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved Medical Devices and, at the same time, prevent Devices that are not safe and effective from entering or remaining on the market.

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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  Devices, Medical, Regulations, Fda regulation of medical devices

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