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AdvaMed Commends Unanimous House Committee Vote on MDUFA V Agreement

WASHINGTON, D.C. – Scott Whitaker, president and CEO of AdvaMed, the world’s largest trade association representing medical technology companies, released the following statement on progress this week in both houses of Congress on the medical device user-fee agreement reached recently between FDA and the medtech industry. Today, the House Committee on Energy and Commerce unanimously (55-0) sent its draft legislation that would codify the agreement commonly known as MDUFA V to the House floor. And yesterday, the Senate HELP Committee released its “discussion draft” of the agreement, which it is expected to mark up and debate in the coming weeks:

“We appreciate the leaders of both Energy & Commerce and HELP for their focus on this important bipartisan user-fee agreement, and for both committees’ work with us to improve the policy on behalf of American patients. We hope both houses are able to achieve swift agreement and send the legislation to the President’s desk. We’re in a golden age of medical technology innovation, which makes this legislation a tremendous opportunity to bring industry’s technical knowledge and development together with FDA’s know-how to help patients.”

Whitaker went on to say: “The improved FDA review times, the addition of specific performance metrics, strong pre-submission guidance for companies, and new policies on carry-over balances and unused funds represent a historic improvement in the user-fee system our companies rely on to improve patient care and outcomes.”

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About AdvaMed  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