title: Ensuring safe and effective medical devices.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md, USA.
authors.forename: David W
authors.initials: DW
authors.lastname: Feigal
authors.forename: Susan N
authors.initials: SN
authors.lastname: Gardner
authors.forename: Mark
authors.initials: M
authors.lastname: McClellan
mesh_terms: D018795:Device Approval; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration