U.S. Supreme Court Ruling Reaffirms FDA Oversight
22/02/08

U.S. Supreme Court Ruling Reaffirms FDA Oversight
WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement in response to today’s (20th Feb 2008) ruling by the U.S. Supreme Court in the matter of Riegel v. Medtronic, Inc.:

“Today’s ruling is a win for patients and public health and safety. It reaffirms what two previous lower court rulings in this case have already made clear -- the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FFDCA) expressly provide for the U.S. Food and Drug Administration’s ultimate regulatory authority over medical devices.

“The FDA – and not a patchwork of state regulations or multiple jury verdicts – should determine the safety and effectiveness of medical technology. We are pleased today’s ruling will allow the FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles.

“Today’s ruling also expressly recognizes the rigorous pre-market approval process which entails extensive pre-clinical and clinical testing and thorough expert FDA review and risk analysis to ensure their safety and effectiveness. In addition, PMA-approved devices must comply with other rigorous post-market requirements including quality systems regulations, adverse event reporting and post-market surveillance. This is why many consider the FDA approval the gold standard for safe and effective medical devices.”