FOR IMMEDIATE RELEASE
June 26, 2008
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AdvaMed Response to Medical Device Safety Act of 2008
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WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement today regarding the introduction of the
Medical Device Safety Act of
2008:
“The Congress provided express preemption authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans.
“A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients.
“The Supreme Court’s 8-1 decision in
Riegel v. Medtronic re-affirmed what most Federal courts have regarded as settled law since 1976 -- that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology.
“This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.”
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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 http://www.advamed.org/.