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Prof. Ralph Hall Testifies Before House Energy and Commerce Subcommittee

FEBRUARY 29, 2012—Professor Ralph Hall was invited to testify at a hearing on reauthorization of the Medical Device User Fee and Modernization Act before the U.S. House Committee on Energy and Commerce‚Äôs Subcommittee on Health on Feb. 15, 2012.

The Subcommittee on Health has been studying, in a series of meetings, the FDA's medical-device review process and its effects on patients, patient access, innovation, jobs, and other areas. The user fee program is intended to provide funding for the FDA's premarket review to ensure safety and effectiveness of medical devices and bring consistency and transparency to the approval process.

Hall has done extensive research on the FDA's process to evaluate the safety and efficacy of new medical devices before they are released to the public, and he has previously testified on the topic before the Subcommittee.

He has also presented his finding to the Institute of Medicine, participated in a Congressional briefing on medical-device issues by the Manhattan Institute, and been interviewed on Medical Progress Today and Minnesota Public Radio. He has worked closely with members of the U.S. Senate Committee on Health Education, Labor & Pensions and others on legislation to improve the FDA's medical-device clearance process.

Others testifying included Jeffrey Shuren, M.D., Director of the FDA's Center for Devices and Radiological Health; Elisabeth M. George, VP of Government Affairs, Regulations, and Standards, Philips Healthcare; Aaron S. Kesselheim, M.D., J.D., professor of medicine, Harvard Medical School; and Lisa Swirsky, senior policy analyst, Consumers Union.