title: Food and drug administration guidance sections. A new paradigm for medical devices. Committee for Clinical Review. FDA.
abstract: The data submitted for Food and Drug Administration (FDA) review of medical devices are often not approved because of poor study design. This article proposes a new approach for developing FDA study design guidance through panels of colleagues from the academic, federal, and private sectors. This piece focuses discussion and thought on Guidance Sections, similar to Study Sections of the National Institutes of Health, to serve as common ground for the continual upgrading of guidance documents through peer review and leading edge scientific and clinical judgement.
authors.affiliation: Devices and Technology Branch, National Heart, Lung and Blood Institute, Bethesda, MD 20892.
authors.forename: J T
authors.initials: JT
authors.lastname: Watson
mesh_terms: D001672:Biocompatible Materials; D004867:Equipment Design; D004864:Equipment and Supplies / Q000592:standards*; D008422:Materials Testing / Q000592:standards; D010380:Peer Review; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001672:Biocompatible Materials