The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and patient advocates—and framing the task as an opportunity to further modernize the agency.
First enacted by Congress after the turn of the millennium, the current iteration of the five-year law is its fifth and has been in place since late 2022. Known as the Medical Device User Fee Amendments, or MDUFA V, it is set to expire in September 2027. MDUFA VI will govern the agency’s Center for Devices and Radiological Health (CDRH) through 2032.
On a basic level, in return for medtech developers paying certain registration and application fees, the FDA commits to specific review timeline goals. Similar, separate arrangements are made for the agency’s reviews of new and generic drugs, biosimilars and over-the-counter medications.
“This is an important process,” FDA Commissioner Martin Makary, M.D., said during the agency’s public meeting. “I knew about user fees—and I knew there were user fees specific to devices—but I never heard the term ‘MDUFA’ until I got ready for this role. I thought it was an enzyme of the pancreas, or something like that.”
“If anyone remembers the pre-user fee days, it wasn’t pretty,” Makary said. “We'd hear stories of giant boxes of paper applications being dropped off at the warehouse—and then perhaps a year later, a company would drop off another application and see their previous applications still sitting in there, not even processed or reviewed.”
Makary said he recently visited some of the FDA’s warehouse facilities and used them as an example of where the agency can modernize—outlining plans to digitize all of its collected files in the coming years and to stop accepting new applications on paper entirely.
“When we have electronic data, we can harness the power of searching for our scientific reviewers and our program managers,” he said, pointing to the FDA’s Elsa project that employs generative AI to aid in document reviews.
“It is a more powerful tool than Google or other basic tools. It's got a million times more power than Excel or Word or any of the basic software systems that we were raised on as we went through our training,” he said. “They don't replace a human being, but they can help a human being organize a gigantic application, identify studies in the literature that the scientific reviewer can read, look for patterns, and ensure that the formatting of the data and the tables is correct.”
Late last month, a report from CNN said multiple FDA employees described Elsa as sometimes unreliable and that it had been known to hallucinate nonexistent studies. Use of the program is voluntary, and it currently cannot help directly with product reviews; Makary told the network that most of the agency’s scientists are using Elsa to summarize meetings and other information.
“People ask me, ‘Is Elsa useful? Are the scientific reviewers liking using Elsa?’” Makary said during Monday’s meeting. “Well, the ones I talk to either love it, or they use it a lot, or they have some questions about how to ask questions to an AI tool.”
“You can't just go on ChatGPT and say, ‘Show me the stuff.’ You have to be specific,” he said. “So we have to have some training. But we know that it has value because we track the number of daily users at the FDA, and there are thousands of unique daily users, so clearly they're finding value in it.”
Another goal of MDUFA is to maintain the FDA and the U.S. as the primary regulator and market of choice, respectively, for the developers of novel medical devices and new technologies, before seeking approvals overseas.
“I want to see American companies thrive, and I want to see companies that do business in the U.S. thrive,” Makary said. “We're not keeping any secrets about our agenda. We've been out there talking about it incessantly.”
“It's a whole new world—we have fierce competition from China, from other countries, from European regulators. We want to be the best. That means we want to be the most efficient, the fastest—and yet not compromise a single iota on our goal to safeguard the public,” he said. “Safety and efficacy is our charge from Congress, and that should be our No. 1 goal.”
However, in offering an asterisk, the agency also took the time to say that striving to be first in the world does not signal a competition but “provides a metric for timely patient access to devices that meet FDA’s standards.”
CDRH Director Michelle Tarver, M.D., Ph.D., said the state of the agency’s device center is strong and that the FDA has been working to ensure data integrity, to quickly communicate safety issues to the public and to address shortages in the medical device supply chain, especially where they impact pediatric care.
“The strength of CDRH is reflected not only in the performance metrics but in the resilience and dedication of our staff and the partnerships we've built and maintained across the medical device ecosystem,” Tarver said. “At the same time, we recognize the demands on our organization are increasing, and we remain focused on evolving to meet them … MDUFA helps us build a future where safety and innovation go hand in hand, and where you as patients benefit first.”
Tarver also pointed to a record number of novel device green lights in 2023, at about 120, and noted that since the start of MDUFA V, the CDRH has granted authorizations to more than 100 devices based on real-world data, demonstrating its regulatory value.
“Continued collaboration with methodologists, data scientists, industry providers, payers and patients, is essential to making real world evidence a predictable, consistent and trusted option along the entire device life cycle,” she said.
The pace of novel device green lights slowed in the first quarter of this year, amid the start of the Trump administration and the launch of layoffs across the federal government—with staff cuts having a disproportionate impact in the FDA’s device center, which had been hiring user-fee-funded staff in recent years specifically to keep pace with newly emerging technologies such as AI.
The CDRH recently updated its running total of clearances and approvals for AI- or machine-learning-powered devices, topping 1,250. They span a range of clinical areas going back decades, though the lion’s share are in radiology and processing images.
“Under MDUFA V, we made progress in securing top talent,” Tarver said. “To sustain that momentum, to continue to realize the full potential of our key programs and to continue delivering meaningful engagements, we will need critical resources in MDUVA VI.”
“A modern CDRH that is driven by gold-standard science requires talented experts; the delivery of leading edge scientific training and professional development; investments in the right technology and the right programs; and the development of critical tools,” she said. “These investments are instrumental to support an increasingly dynamic and data rich regulatory landscape.”
On the topic of FDA layoffs, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said he was glad to see the turnaround after the agency began rehiring some staff.
“There's obviously been some dynamics around staffing,” Leahey said. “We appreciate that Dr. Makary has been very vocal about the importance of making sure we keep reviewers, we keep inspectors and maintain that expertise to advance patient care.”
“When we look at the program—and we've polled our members multiple times, at the outset of these negotiations—and interestingly, 95% of our members said they value the quality of the journey over the time of the journey.”
Leahey said the MDMA will look to ensure that industry user fees are invested in front-line product teams and that the agency could potentially return to the practice of publicizing exactly how many reviewers and medical officers are funded.
“The first year of the user fee program was 2003, and $21 million was collected in user fees that year. In FY26 … over $427 million was authorized to be collected from user fees,” he said. “Not saying it's good or bad, but we have to realize the size and scope of the investments here and that this is not a sustainable pathway … Industry just wants to try to have some additional visibility as to where those dollars are going.”
AdvaMed’s Janet Trunzo also went through the history of the user fee program: “The first MDUFA contained goals that turned out to be too complex, and those were adjusted in MDUFA II.”
“In MDUFA III, we introduced the concept of total time-to-decision goals, to reflect that patient access to a device is based on total elapsed time. In MDUFA IV, we focused on the pre-submission process, in recognition that the quality and timing of an application and review depends in part on the ability to obtain feedback prior to its submission to the agency.”
“And for MDUFA V, we expanded the international regulatory program to support FDA’s global regulatory harmonization activities,” said Trunzo. “We also added specific hiring targets and opportunities to add investments for improved decision goals.”
“Each MDUFA cycle included significant resources and investments, including increasing the number of FTEs to support the program. Now that we have approached nearly 25 years—can't believe I’m saying that—25 years of user fee programs for medical devices, we are now in a position of merely fine-tuning the current program,” she said. “It has worked well to achieve our common goal of timely patient access to safe and effective medical technology.”