title: Institutional review boards and medical devices.
authors.forename: J R
authors.initials: JR
authors.lastname: Less
authors.forename: S
authors.initials: S
authors.lastname: Alpert
authors.forename: S L
authors.initials: SL
authors.lastname: Nightingale
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards / Q000706:statistics & numerical data; D026724:Ethical Review; D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D011367:Professional Staff Committees; D012306:Risk; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration