AdvaMedDx Statement on FDA's OIVD Triage Pilot Program

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AdvaMedDx Statement on FDA's OIVD Triage Pilot Program

April 20, 2012

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, released the following statement regarding the Triage pilot program from the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety:

“AdvaMedDx has long advocated for a risk-based approach to the regulation of all diagnostics, including triage of tests that are well-established to truly novel, to promote efficiency and consistency in review process and promote best use of FDA resources.

“Although we are still learning the details of the Triage pilot program, we applaud its introduction and look forward to reviewing the results.”

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.