AdvaMed Statement on the FDA’s Draft Commitment Letter on the Medical Device User Fee Amendments V Agreement
WASHINGTON, D.C. – The Food and Drug Administration (FDA) has released its draft commitment letter on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA), reflecting an agreement between the agency and the medical technology device industry. The agreement is now ready for public and congressional consideration. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), made the following comment on the agreement.
“The medtech industry is poised to unleash a whole new dimension of innovation for patients in the coming years. Technology is making possible what once seemed impossible. This historic agreement connects increased industry user fees to FDA performance for the first time. It holds innovators to high standards for communicating device performance to the agency. The result will be more timely decisions on medical technology earning the FDA’s global gold standard of safety and effectiveness. AdvaMed looks forward to public and congressional consideration of the agreement. The future of life-saving, life-enhancing medical technology for patients is brighter than ever under this vision.”
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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.