FOR IMMEDIATE RELEASE
May 13, 2008
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Preemption Critical in Preventing
“Patch Work” Regulatory Approach to Medical Devices
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WASHINGTON, D.C. – Christopher White, executive vice president and general counsel for the Advanced Medical Technology Association (AdvaMed), released the following statement regarding federal preemption related to certain medical devices in advance of a hearing tomorrow on preemption by the House Oversight and Government Reform Committee:
“In 1976, Congress approved a science-based approach to the regulation of medical devices, understanding that a federal agency applying a uniform and rigorous safety and effectiveness review standard across all 50 states was in the best interests of patients. In doing so, Congress prevented a patchwork approach to regulation where medical devices may have different standards depending upon the state in which you live.
“For more than 30 years, this system has worked well. The United States leads the world in the development of safe and effective devices. Patients everywhere enjoy improved health outcomes and greater quality of life and independence thanks to innovations in medical technology.
“Eliminating the fundamental legal principle that helps create an environment where innovation can flourish, in favor of the uncertainty and variations inherent in a state-based scheme, is not in the best interests of patients.
“The assertion that companies have no liability when patients are injured by medical devices is simply not true. There are a host of civil and criminal penalties manufacturers are subject to for failing to follow FDA requirements. Moreover, the Supreme Court recently affirmed that the preemption Congress provided for medical devices does not apply if a device manufacturer has withheld information from the FDA or manufactured a defective product.”
# # # AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.