title: FDA's new regulatory paradigms for in vitro diagnostic devices.
authors.affiliation: Food and Drug Administration, Rockville, Maryland, USA.
authors.forename: M
authors.initials: M
authors.lastname: Robinowitz
authors.forename: S I
authors.initials: SI
authors.lastname: Gutman
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
chemical_list: D011933:Reagent Kits, Diagnostic