Congress Passes “Historic” MDUFA V Reauthorization
WASHINGTON, D.C. – Today, Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system’s implementation in 2002. The Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, has worked alongside FDA and Congressional leaders to negotiate a final agreement that provides FDA with the resources it needs to review device submissions in a timely, efficient, and cost-effective way.
AdvaMed President and CEO Scott Whitaker released the following statement:
“The bipartisan passage of this historic five-year agreement sets the stage for a new era of innovation in health care, ensuring greater predictability, consistency, accountability, and communication between FDA and the medtech innovators who are changing the way patients seek and receive life-saving care. We are in a golden age of medical technology innovation, and the improvements made by MDUFA V will serve as a catalyst for even greater health care transformations.
“On behalf of our industry, I want to thank HELP Chair Murray and Ranking Member Burr, E&C Chairman Pallone, and Ranking Member McMorris Rodgers for their bipartisan leadership and important work over the course of this negotiation. We look forward to continuing to work with Congressional leaders and FDA officials to ensure the most effective treatments and diagnostics are available to the patients who need them most.”
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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. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.