FDA - Not Lawsuits - Should Determine Safety & Efficacy of Medical Technology
WASHINGTON, Dec. 4 /PRNewswire-USNewswire/ -- AdvaMed General Counsel Christopher White issued the following statement today regarding oral arguments presented before the U.S. Supreme Court on the matter of Riegel v. Medtronic, Inc.:
"As was made clear in today's arguments, the safety and efficacy of medical technologies are best determined by Food and Drug Administration (FDA) scientists -- not by lawsuits filed in courtrooms across the country. Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access to these life-saving and live enhancing products.
"The comprehensive pre-market approval process at the FDA subjects medical devices to intense scrutiny at every stage of development and marketing -- from clinical studies to real-world clinical use. A state-law liability approach to assessing safety and effectiveness would undermine this approach to patient safety. It also would override the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies.
"We are hopeful the Supreme Court will re-affirm the two previous lower court rulings in this case which made clear that the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA) expressly provide for FDA's ultimate regulatory authority in these matters."
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.
Copyright©2007 PR Newswire.
All rights reserved