WASHINGTON, D.C.—AdvaMed, the Medtech Association, today expressed strong support for the draft Medical Device User Fee Amendments (MDUFA) VI agreement at an FDA public hearing.
“On behalf of AdvaMed and the medtech industry, we strongly support the proposed MDUFA VI commitment letter,” said Zach Rothstein, executive vice president of Digital and Diagnostics Technologies. “It builds on what is working, makes practical improvements where they are needed, and prepares the program for the technologies FDA will regulate in the years ahead while ensuring the United States remains the world’s leading destination for medical technology innovation. And most importantly, it will support timely patient access to safe and effective medical technology and continue to give providers confidence in the tools they use every day.”
His statement is available here. The draft agreement, expressed as a commitment letter, is available here.
After the public meeting, FDA will send a final commitment letter to Congress by Jan. 15, 2027. Congress and the President must enact the legislation by Sept. 30, 2027.
AdvaMed looks forward to working with Congress to support the timely reauthorization of MDUFA.
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