Primer on medical device regulation. Part II. Regulation of medical devices by the U.S. Food and Drug Administration.
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Department of Radiology, Washington Hospital Center, Washington, DC 20010-2975, USA.
D003257:Consumer Product Safety; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards*; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration