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Laboratory developed tests, or LDTs, help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure these tests work.
Both the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) believe patients and providers need to have confidence that laboratory tests work.
Today, the FDA and CMS issued a joint statement reiterating mutual support of FDA oversight of the analytical and clinical validity of LDTs.
Questions?
If you have questions, contact CDRH Trade Press.
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