Archive: Regulatory Issues: Effects on Evidence-Based Medicine of Laboratory Tests

572 views · Published 15 September 2009 · 55:43 · Indexed 20 September 2026

Channel: UW Video · 2009 · Education

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Some research has suggested that up to 80% of the US health care dollar is driven by diagnostic tests.  The world of in vitro diagnostic testing though is often a hidden part of clinical medicine.  In this talk, Dr. Larry Kessler from the School of Public Health and Community Medicine at the University of Washington describes the US Food and Drug Administrations approach to classification of in vitro diagnostic devices FDA and their regulatory pathways.

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