BETHESDA, Md.--(BUSINESS WIRE)--The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular testing professionals and leading education initiatives, discussions, and policy actions central to improving the development and application of molecular diagnostics, today reaffirmed its position that the vast majority of laboratory developed tests (LDTs), or laboratory developed procedures (LDPs)—a term coined by AMP to more appropriately capture the nature of these processes as medical services—should continue operating under the regulation of the Clinical Laboratory Improvement Amendments (CLIA) program at the Centers for Medicare & Medicaid Services (CMS), and not be subject to pre-market review by the U.S. Food and Drug Administration (FDA), as suggested in the draft guidance notification issued to Congress on July 31, 2014.
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