What does the FDA’s final rule on LDTs change? The rule makes it explicit that in vitro diagnostics (IVDs) that are manufactured by clinical laboratories—i.e., laboratory-developed tests (LDTs)—are considered devices under the Federal Food, Drug, and Cosmetic Act (FDCA). IVDs are tests performed on samples such as blood or tissue that have been taken from the human body. LDTs are ...
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Laboratory Diagnosis of Hemoglobinopathies and Thalassemia Archana M Agarwal, MD Medical Director, Hematopathology and RBC Laboratory ARUP Laboratories Assistant Professor of Pathology University of Utah Department of Pathology