Criteria for well-controlled device and diagnostic product investigations.
D000818:Animals; D003933:Diagnosis; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D066298:In Vitro Techniques; D007883:Legislation, Medical; D012106:Research / Q000592:standards*; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration