title: An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
authors.affiliation: From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Owen
authors.initials: O
authors.lastname: Faris
authors.affiliation: From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Shuren
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D018795:Device Approval; D006801:Humans; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration