title: FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science.
authors.affiliation: Department of Health and Mental Hygiene, Baltimore, Maryland.
authors.forename: Joshua
authors.initials: J
authors.lastname: Sharfstein
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration