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FDA and CMS form task force on LDT quality requirements

from FDAVoice

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality. Under the Food and Drug Administration's proposed framework for the oversight of laboratory developed tests, outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services, which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments. more


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