title: US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.
authors.affiliation: Department of Pathology, Georgetown Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, DC.
authors.forename: Mary K
authors.initials: MK
authors.lastname: Sidawy
mesh_terms: D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration