AdvaMed Response to the Medical Device Safety Act

March 5, 2009

WASHINGTON, March 5 /PRNewswire-USNewswire/ -- Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement today regarding the re-introduction of the Medical Device Safety Act of 2009:

"This bill does not in any way improve patient safety. It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.

"If enacted, this legislation would effectively allow state courts to review medical devices and ultimately lead to a patchwork of inconsistent and confusing guidance on the use of medical treatments for patients and physicians, or limit their availability altogether.

"America needs a central expert authority to regulate medical devices based on a scientific risk-based approach to public health and safety for all Americans, not ad hoc regulation through state court verdicts. The Congress provided FDA with this central authority more than 30 years ago, and we should not weaken the agency's effectiveness or ability to meet its mandate to protect the public health and safety.

"The Supreme Court's 8-1 decision in Riegel v. Medtronic simply re-affirmed what most federal courts have regarded as settled law -- that FDA should determine the safety and effectiveness of medical technology."

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.

SOURCE Advanced Medical Technology Association