title: FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?
authors.affiliation: Department of Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA. mscott@labmed.wustl.edu
authors.forename: Mitchell G
authors.initials: MG
authors.lastname: Scott
authors.forename: Edward R
authors.initials: ER
authors.lastname: Ashwood
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Annesley
authors.forename: Debra G B
authors.initials: DG
authors.lastname: Leonard
authors.forename: Michael C
authors.initials: MC
authors.lastname: Burgess
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D033161:Government Regulation; D007883:Legislation, Medical; D014481:United States; D014486:United States Food and Drug Administration