Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (FDA) testified before the US Senate Health, Education, Labor, and Pensions (HELP) Committee at a hearing on “Continuing America’s Leadership: The Future of Medical Innovation for Patients”, April 28, 2015. Dr. Shuren was invited to appear as a distinguished witness to discuss the FDA's mission to ensure appropriate patient protection while promoting patient access to innovative medical devices. In his written statement on new uses of evidentiary and analytical tools in regulatory science, Dr. Shuren described the use of the highly detailed, anatomically correct, computational whole-body Virtual Family (VF) models – developed in a international collaboration led by the IT’IS Foundation and the FDA – for electromagnetic, thermal, acoustic, and computational fluid dynamics simulations that could be used to supplement or even replace data from clinical investigations of new devices.
Also testifying before the Senate HELP Committee – chaired by Senator Lamar Alexander (R-TN), with members Patty Murray (D-WA), Robert P. Casey, Jr (D-PA) Elizabeth Warren (D-MA), Michael F. Bennet (D-CO), Johnny Isakson (R-GA), Pat Roberts (R-KS), Tim Scott (R-SC), and Bill Cassidy (R-LA) in attendance – were Janet Woodcock, M.D., Director of the FDA Center for Drug Evaluation and Research, and two distinguished witnesses from the National Institutes of Health, Christopher P. Austin, M.D. Director of the National Center for Advancing Translational Sciences and Roderic I. Pettigrew, Ph.D., M.D., Director of the National Institute of Biomedical Imaging and Bioengineering.