WASHINGTON, D.C.—AdvaMed, the medtech association, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next agreement, MDUFA VI, delivers strong results for the American public.
“We appreciate Commissioner Makary’s commitment to creating a more agile and efficient FDA, which benefits the American patients we all serve and will help maintain U.S. medtech’s global leadership position and FDA’s reputation as the global gold standard for medtech regulation,” said Scott Whitaker, AdvaMed president and CEO. “MDUFA V was a historic agreement that brought greater accountability and reliability to the review process, and we look forward to this next agreement building upon that success.”
Speaking at the FDA meeting from AdvaMed were Janet Trunzo, senior executive vice president, Technology and Regulatory Affairs; Zach Rothstein, executive director of AdvaMedDx, representing in vitro diagnostic (IVD) test makers; andPatrick Hope, executive director of the Medical Imaging division.
“From the very first device user fee program in 2002, our shared goal of timely patient access to safe and effective medical technology has not changed and remains our North Star,” Trunzo said. “Whether we are discussing review timelines or regulatory pathways, we must never lose sight of the patients waiting for the next breakthrough or life-saving device. The device industry and FDA are united in this mission.” Her full statement is available here.
“Simply put: Modern medicine is impossible without modern IVDs. And it is on behalf of this critical, life-saving industry that I speak today,” Rothstein said. “As Janet stated, our North Star remains unchanged: ensuring patients have timely access to safe and effective medical technology. For the diagnostics industry, this means ensuring that the tests physicians and patients rely on to make critical health care decisions are accurate and available when needed most.” His full statement is available here.
“Medical imaging technologies continue to revolutionize health care delivery in America and around the world, extending human vision into the very nature of disease,” Hope said. “Technology that was once unimaginable is now the medical standard of care. The next generation of imaging technologies will further advance health care and the practice of medicine. A transparent and predictable FDA premarket review process is essential to continuing prompt patient access to these innovative technologies.” His full statement is available here.
In each MDUFA process, FDA and the medtech industry agree on the parameters, and Congress determines whether to authorize the agreement through passing legislation, then signed into law by the President. The MDUFA VI reauthorization will cover fiscal years 2028 through 2032. The current legislative authority for the medical device user fee program (MDUFA V) expires Sept. 30, 2027.
MDUFA V made several key improvements reflecting FDA’s ever-increasing workload to review medtech products, including key performance targets, new timelines to reduce decision times, and budgetary incentives to meet the agreement’s goals.