title: Medical devices. Significant risk vs nonsignificant risk.
authors.affiliation: Department of Medicine, Bowman Gray School of Medicine, Winston-Salem, NC 27157-1042.
authors.forename: R J
authors.initials: RJ
authors.lastname: Sherertz
authors.forename: S A
authors.initials: SA
authors.lastname: Streed
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D026724:Ethical Review; D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D006761:Hospitals / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D011367:Professional Staff Committees; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration; D014546:Urinary Catheterization / Q000295:instrumentation