title: A regulatory perspective on in vitro diagnostics.
authors.affiliation: U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Gottlieb
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D018795:Device Approval; D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation* / Q000592:standards*; D017277:Drug Approval; D033161:Government Regulation; D014481:United States; D014486:United States Food and Drug Administration