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Dr. David Challoner

Dr. David Challoner

VP for Health Affairs Emeritus, University of Florida
David R. Challoner, M.D. is vice president emeritus for Health Affairs of the University of Florida.  Dr. Challoner has held leadership and health policy positions in many national organizations including the Association of American Medical Colleges where he holds Distinguished Service membership, the American Medical Association where he served as chairman of the Section on Medical Schools, and the American Federation for Clinical Research where he served as President.  From 1988-1990, he was appointed by President Reagan to chair the President's Committee on the National Medal of Science. He also served as chairman of the membership committee, as a member of the governing council of  the Institute of Medicine and as a member of the governing board of the National Research Council.  He received the 2010 Walsh McDermott Medal of the IOM for Distinguished Service.  He chaired the IOM’s Committee on the Public Health Effectiveness of the FDA 510K Clearance Process (2011).

More About Dr. David Challoner

The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.

Friday, July 29, 2011

Testimony for the record based on the IOM’s report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 years.

Tuesday, November 15, 2011
Thursday, August 11, 2011