AdvaMedDx Hill Briefing on Critical Care Diagnostics

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AdvaMedDx Hill Briefing on Critical Care Diagnostics

June 21, 2012

AdvaMedDx promotes the value of innovative, safe and effective diagnostic tests and advocates for risk-based regulation of all diagnostics. Currently, the Food and Drug Administration (FDA) has regulatory oversight of all diagnostic tests that are considered to be medical devices, including those manufactured and sold as kits to laboratories, physician offices and patients. Most tests that are developed and offered within a particular laboratory, called laboratory developed tests – LDTs – are regulated through the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments, or CLIA. The FDA has indicated plans to apply a risk based regulatory approach to LDTs, and the agency is developing a framework for implementation.

For more information, please contact: Wanda Moebius @ (202) 434-7240

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AdvaMedDx member companies produce advanced, in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is the only multi-faceted, policy organization that deals exclusively with issues facing in vitro diagnostic companies both domestically in the United States and abroad. For more information, visit www.advameddx.org.