MDUFA VI Discussions Begin at FDA Public Meeting

AdvaMed today kicked off the latest Medical Device User Fee Amendments (MDUFA) discussion during a public meeting at the U.S. Food and Drug Administration’s (FDA) headquarters in Silver Spring, Md. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next pact (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,” AdvaMed President/CEO Scott Whitaker said. “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.”

AdvaMed’s representatives at the FDA meeting were Janet Trunzo, senior executive vice president, Technology and Regulatory Affairs; Zach Rothstein, executive director of AdvaMedDx, representing in- vitro diagnostic (IVD) 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 stated. “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.”

“While user fees support timeliness and predictability by providing FDA with additional resources, user fees are not a guarantee of approval,” she continued. “They never have been, and they never should be. User fees provide additional resources to the agency to conduct thorough, consistent and predictable reviews. This benefits everyone—patients get timely access to needed technologies, companies can plan their development timelines more effectively, and FDA can maintain the world’s gold standard for device regulation.” Trunzo’s 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 commented. “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.”

“With more than 75 percent of our members being small businesses, we have a particular interest in ensuring the MDUFA program continues to support small company success,” Rothstein emphasized. “Small diagnostic companies often develop innovative tests but may lack the regulatory resources of larger organizations. Programs like the presubmission process, small business fee waivers, and dedicated FDA small business assistance have been invaluable.” Rothstein’s full statement is available here.

In each MDUFA process, FDA and the medtech industry agree on the parameters. Congress must authorize the agreement and it must be signed by the President in order for the pact to take effect. 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 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.” 

“User fees provide funding for adequate FDA resources with scientific expertise to conduct rigorous yet efficient pre-market review, allowing health care providers to have access to innovative medical devices in an expedient, consistent, and transparent manner,” Hope added. “Our companies are actively developing new, innovative technologies for patient care that will depend on the continuation of these efficient, scientifically based regulatory premarket review pathways. Simply put, our ability to bring lifesaving, innovative technologies safely and effectively to patients and health care providers has been realized by the premarket review pathway supported by the MDUFA program. Hope’s full statement is available here. 

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.