title: Laboratory developed tests in the clinical laboratory: challenges for implementation.
authors: Department of Medicine, Johns Hopkins University School of Medicine, 1800 Orleans St. Sheikh Zayed Tower, B1020-F, Baltimore, MD 21287, USA.|Department of Pathology, Johns Hopkins University School of Medicine Baltimore, MD 21287, USA.
authors: Mark A
authors: MA
authors: Marzinke
authors: Department of Medicine, Johns Hopkins University School of Medicine, 1800 Orleans St. Sheikh Zayed Tower, B1020-F, Baltimore, MD 21287, USA.
authors: William
authors: W
authors: Clarke
mesh_terms: D064790:Clinical Laboratory Services / Q000706:statistics & numerical data*; D019411:Clinical Laboratory Techniques / Q000379:methods*; D006801:Humans
keywords: Clinical Laboratory Improvement Amendments; US FDA; laboratory developed tests; oversight; regulation