U.S. companies will see few changes from the latest Medical Device User Fee Amendments, but overseas firms will face higher costs than under the current five-year pact.
The MDUFA negotiation process between the Food and Drug Administration and the medtech industry determines how much the agency can raise in medical device fees between 2028 and 2032.
In a public meeting Wednesday, industry leaders broadly supported the latest agreement, MDUFA VI, while patient groups called for more of an emphasis on postmarket safety.
Michelle Tarver, director of the Center for Devices and Radiological Health, said the reauthorization process was collaborative, with the draft agreement focusing on themes such as clearer communication, more consistent reviews and transparency.
The FDA will take feedback through the end of the year, with plans to submit the final package to Congress in January and for the government to pass the new budget by September 2027.
User fees increase for overseas firms
The amount medical device companies will need to pay in user fees per year will remain relatively flat, or even decrease for certain U.S. firms, said acting FDA Commissioner Kyle Diamantas.
This is offset by increases to overseas firms. Small business fee waivers will be limited to U.S. firms, and the FDA’s Center for Devices and Radiological Health is proposing higher establishment registration fees for foreign companies to account for higher expenses with inspections and imports.
The total package comes out to about $580 million per year, roughly 1.5% above baseline, said Eli Tomar, deputy director of the Office of Policy for the FDA’s Center for Devices and Radiological Health.
Medtech lobbyist Advamed spoke in favor of the new agreement. Zach Rothstein, Advamed’s executive vice president of digital and diagnostics technologies, said the trade group “strongly supports” MDUFA VI, adding that it keeps stable fee levels and focuses on strengthening existing programs rather than starting new initiatives.
Review goals are unchanged
The goals for when the FDA must make a decision on device clearance or approval remain unchanged. The agency is, however, adding a new focused follow-up option for premarket submissions, which would allow companies to send in questions within 45 days of a recent pre-submission.
No hiring requirements, but more transparency
The latest agreement forgoes the current hiring targets of MDUFA V, but will include regular reporting on the number of employees and new hires at the CDRH. The reporting requirement follows a year in which the Trump administration cut thousands of workers across the FDA with little notice or explanation.
Mark Leahey, CEO of the Medical Device Manufacturers Association, said the trade group hoped to have more people doing pre-market reviews at this point in time.
In the last few years, “the number of net new hires in the CDRH program dealing with the device review process has actually decreased, but we didn’t really have a way in which we could get that information reported out,” Leahey said.
More public reporting would be beneficial for everyone, he added.
TAP program becomes permanent
The total product lifecycle advisory program, or TAP, which started as a pilot under MDUFA V, will become a full-fledged program with a refined scope. The program is intended to provide access to early and frequent communications with the FDA for innovative medical devices. It also involves help designing studies so that device firms can provide the evidence that payers, such as Medicare, are seeking.
Diana Zuckerman, president of the National Center for Health Research, emphasized the importance of representation in clinical trials, adding that people with chronic disabilities often aren’t represented.
“We know that many device companies have been unhappy when their devices aren’t automatically covered by Medicare, but we also know that if a device doesn’t have clinical trials, or if it has clinical trials that don’t include people over the age of 65, it is very hard for Medicare to justify that device as reasonable and necessary,” she said.
Real-world evidence and representative data
The new agreement expands the use of real-world evidence, which can include data collected from insurance claims, health records and wearable devices. The FDA also intends to support the use of technology to recruit patients representative of a device’s intended use for clinical trials.
Patient groups and digital health advocates said the use of real-world evidence should be considered for review of devices after they have entered the market, not just premarket review.
“The best data on real-world evidence is going to be after the fact, not prior to it,” Zuckerman said, calling for the FDA to reconsider this measure.
Benjamin Vandendriessche, chief scientific officer of Digital Medicine Society, also called for the use of real-world data postmarket.
