[20191216]IF11389_FDA实验室开发试验（LDTs）法规.pdf

https:/crsreports.congress.gov December 16, 2019FDA Regulation of Laboratory-Developed Tests (LDTs)Laboratory-developed tests (LDTs) are a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single laboratory. LDTs are often used to test for conditions or diseases that are either rapidly changing (e.g., new strains of known infectious diseases) or that are the subject of quickly advancing scientific research (e.g., genomic testing for cancer). The majority of genetic testsa type of IVD that analyzes various aspects of an individuals genetic material (e.g., DNA, RNA)are LDTs. Federal agencies involved in the regulation of LDTs include the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). FDA regulates the safety and effectiveness of the diagnostic test, as well as the quality of the design and manufacture of the diagnostic test, pursuant to authorities in the Federal, Food, Drug, and Cosmetic Act (FFDCA). CMS regulates the quality of clinical laboratories and the clinical testing process pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This In Focus addresses only FDAs role in