WASHINGTON, Sept. 21 AdvaMed President and CEO Stephen J. Ubl issued the following statement today following Senate passage of the FDA Amendments of 2007, which includes language reauthorizing the medical device user fee program and other device-related provisions:
"The passage of the FDA Amendments of 2007 is good news for patients, the FDA, and for medical technology. It will ensure patients continue to have access to safe and effective medical devices without unnecessary delays. This legislation also enhances patient safety by providing FDA's device program with the financial resources it needs to meet its medical technology review commitments, while protecting future FDA appropriations and providing manufacturers with predictability regarding user fee rates.
"This legislation enjoys strong bipartisan support, and we hope the President will act quickly to enact this legislation prior to the current user fee program's expiration on Sept. 30. We look forward to working with the Administration in implementing this important legislation."
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 Advance Medical Technology Association (AdvaMed)