The FDA’s Center for Devices and Radiological Health has released a draft version of the sixth iteration of the Medical Device User Fee Agreement (MDUFA VI), which will govern user fees for fiscal years 2028 through 2032. According to an accompanying fact sheet, this agreement will be focused on improvements to existing premarket programs rather than on additions to the current array of programs.
While the draft agreement provides limited information regarding specific user fee amounts, CDRH stated that it seeks to
The fact sheet states that companies operating outside the U.S. will be called upon to contribute “an appropriate share of user fee revenue,” to account for the additional FDA resources required to provide oversight of overseas manufacturing facilities. Under MDUFA VI, smaller companies will continue to qualify for fee reductions for marketing submissions, but these manufacturers may not be required to provide documentation of financial hardship to obtain a registration fee waiver.
CDRH stated that these changes suggest that fees for all premarket submission types will decrease in fiscal year 2028. “U.S.-based firms, among others, will see total fees coming down,” the fact sheet stated. Participation in the pre-submission program will come with a fee of $2,000, but this amount will be applied toward fees paid for the corresponding premarket submission.
The Total Product Life Cycle (TPLC) advisory program (TAP) will transition from the status of a pilot program under MDUFA V to a permanent program as of the beginning of fiscal year 2028. The agency stated that under MDUFA VI, the TAP program “will function as a strategic bridge between the FDA and the Centers for Medicare & Medicaid Services.” Participants in the TAP program will be able to engage both agencies concurrently regarding their novel technologies with the potential benefit of reducing the time to Medicare coverage.
Under MDUFA VI, harmonization with other regulators, including the International Medical Device Regulators Forum (IMDRF), will continue and expand. CDRH stated that other harmonization efforts will include a greater level of activity in bilateral regulatory reliance programs, one of several aspects of the center’s 2023 harmonization plan. CDRH will continue adopting and using internationally recognized consensus standards as well. This activity helps reduce the friction in premarket reviews and inspections encountered in different regulatory jurisdictions by leveraging widely recognized device performance benchmarks.
AdvaMed President/CEO Scott Whitaker said in a July 8 statement that the MDUFA VI agreement would provide the FDA with resources essential to the operations at CDRH. Whitaker said further progress toward ratification of MDUFA VI “is an important step toward preserving the seamless access to proven medtech.” However, ratification would also provide “the stability and predictability medtech innovators need to continue their critical work,” Whitaker stated.
According to the AdvaMed statement, the FDA will send the final commitment letter to Congress Jan. 15, 2027. Historically, device user fee agreements are authorized by Congress as part of a larger legislative vehicle that may include user fee agreements for other product centers at the agency. The MDUFA VI agreement must be legislatively enacted by Sept. 30, 2027, to be effective at the beginning of FY 2028.