title: Clinical investigations with medical devices. New rules.
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D007258:Informed Consent; D007883:Legislation, Medical; D012108:Research Personnel; D012306:Risk; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration