AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.
AdvaMed today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at the US Food and Drug Administration (FDA) headquarters.
Three AdvaMed senior staff members encouraged the agency to build on the five prior agreements to ensure the next agreement, MDUFA VI, delivers results for the American public. “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,” says Scott Whitaker, AdvaMed president and CEO.
Speaking at the FDA meeting from AdvaMed were Janet Trunzo, senior executive vice president of technology and regulatory affairs; Zach Rothstein, executive director of AdvaMedDx, representing in vitro diagnostic test makers; and Patrick 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 says in a statement. “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.”
MDUFA Processes
In each MDUFA process, FDA and the medtech industry agree on the parameters, and Congress determines whether to authorize the agreement through passing legislation, which is 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.
“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 says in a statement. “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.”
MDUFA V made several updates in 2022, reflecting FDA’s 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.
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