title: The FDA's perspective on clinical laboratory devices. The premarket review and evaluation process.
authors.affiliation: Div. of Clinical Laboratory Devices, Food and Drug Administration, Rockville, MD 20857, USA.
authors.forename: K J
authors.initials: KJ
authors.lastname: Aziz
authors.forename: C A
authors.initials: CA
authors.lastname: Sliva
authors.forename: S I
authors.initials: SI
authors.lastname: Gutman
mesh_terms: D002624:Chemistry, Clinical / Q000295:instrumentation*; D004869:Equipment Safety; D005188:False Negative Reactions; D008389:Marketing of Health Services; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*