The United States Food and Drug Administration (FDA) and representatives from the medical device industry have reached a preliminary agreement on the sixth iteration of the Medical Device User Fee Amendments (MDUFA VI), a framework that will govern the agency’s device review funding and performance goals from 2028 through 2032. While the agreement promises stability for domestic manufacturers, it signals a significant shift in the financial burden of regulation toward international companies. Under the proposed terms, overseas firms will face substantially higher registration fees, a move designed to offset the rising costs associated with foreign inspections and the complex logistics of monitoring imported medical technologies.
The MDUFA negotiation process is a high-stakes legislative ritual that occurs every five years. It determines the "user fees" that medical device companies must pay to the FDA to supplement congressional appropriations. In exchange for these fees, the FDA commits to meeting specific performance goals, such as timelines for reviewing premarket approvals (PMA) and 510(k) submissions. During a public meeting held on Wednesday, agency officials and industry stakeholders detailed a package that prioritizes the refinement of existing programs over the launch of new, large-scale initiatives, reflecting a desire for institutional stability following a period of significant workforce volatility.
The Financial Framework and the Shift to Foreign Fee Burden
The total funding package for MDUFA VI is projected at approximately $580 million per year, representing a modest 1.5% increase above the current baseline. However, the distribution of these costs marks a departure from previous agreements. Acting FDA Commissioner Kyle Diamantas noted that for many U.S.-based firms, annual user fees will remain relatively flat or may even decrease in certain categories. This domestic relief is made possible by a strategic restructuring of fees for foreign entities.
Specifically, the FDA’s Center for Devices and Radiological Health (CDRH) is proposing higher establishment registration fees for overseas companies. The agency justifies this increase by pointing to the escalating expenses involved in conducting international inspections and managing the oversight of global supply chains. Furthermore, the agreement stipulates that small business fee waivers—which significantly reduce the financial barrier for startups seeking device clearance—will be restricted exclusively to U.S.-based firms. This "America-first" approach to fee structures reflects broader economic trends aimed at bolstering domestic manufacturing while ensuring that the cost of regulating imports is covered by the entities seeking entry into the U.S. market.
Eli Tomar, deputy director of the Office of Policy for the CDRH, emphasized that the 1.5% increase is a calculated adjustment intended to maintain the agency’s operational capacity without imposing undue hardship on the domestic innovation ecosystem. By focusing the increases on foreign registration, the FDA aims to ensure that the rigorous safety standards required for imported devices are adequately funded.
Chronology and the Path to Reauthorization
The path to MDUFA VI follows a strict statutory timeline mandated by Congress. The negotiations between the FDA and industry trade groups—including the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA)—have been ongoing for months. Following the public meeting held this week, the process enters a formal feedback phase.
The FDA will continue to accept public comments and stakeholder feedback through the end of the current calendar year. Once this feedback is integrated, the agency plans to submit the finalized legislative package to Congress in January 2025. This early submission is intended to give lawmakers ample time to review and debate the provisions before the current MDUFA V agreement expires. The goal is for the federal government to pass the new budget and reauthorization by September 2027, ensuring a seamless transition into the MDUFA VI cycle on October 1, 2027.
Michelle Tarver, the newly appointed director of the CDRH, characterized the reauthorization process as a "collaborative effort." She noted that the draft agreement focuses on three core pillars: clearer communication between the agency and sponsors, more consistent review outcomes across different device branches, and enhanced transparency regarding the FDA’s internal processes.
Staffing Stability and the Rejection of Hiring Targets
One of the most notable departures from the previous MDUFA V agreement is the absence of specific hiring targets. MDUFA V was characterized by aggressive goals to expand the FDA’s workforce to keep pace with the explosion of digital health and innovative diagnostics. However, MDUFA VI pivots away from these mandates, focusing instead on reporting and transparency regarding the existing workforce.
This shift comes in the wake of significant controversy surrounding the FDA’s personnel management. During the latter half of the Trump administration, the CDRH saw a sudden reduction in force, with thousands of positions cut or left unfilled with little public explanation. These cuts created a bottleneck in device reviews and strained the relationship between the agency and industry leaders who were paying user fees intended to fund those very positions.
Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), expressed a cautious stance on the new staffing provisions. Leahey noted that while the industry had hoped for an increase in the number of personnel dedicated to pre-market reviews, the net number of new hires in the CDRH program has actually decreased in recent years. "We didn’t really have a way in which we could get that information reported out," Leahey said, referring to the lack of visibility into staffing levels.
Under MDUFA VI, the FDA will be required to provide regular, detailed reporting on the number of active employees and new hires within the CDRH. This move toward transparency is intended to rebuild trust and ensure that the funds collected from industry are being utilized to maintain a robust and efficient review staff.
Making the TAP Program Permanent
A cornerstone of the MDUFA VI agreement is the transition of the Total Product Lifecycle Advisory Program (TAP) from a pilot phase to a permanent, full-fledged program. Launched under MDUFA V, the TAP program was designed to facilitate early and frequent communication between the FDA and medical device innovators, particularly those developing "Breakthrough" technologies.
The permanent version of TAP will feature a refined scope, focusing on providing strategic advice not just on regulatory approval, but on the entire lifecycle of a product. This includes helping firms design clinical studies that generate the specific types of evidence required by payers, such as the Centers for Medicare & Medicaid Services (CMS).
The integration of regulatory and reimbursement considerations is a major win for the industry. Historically, many companies found themselves in a "valley of death" where they achieved FDA clearance but failed to secure insurance coverage because their clinical data did not meet the specific needs of payers. By making TAP permanent, the FDA is acknowledging that regulatory success is only one part of the equation for patient access.
However, the expansion of TAP is not without its critics. Diana Zuckerman, president of the National Center for Health Research, raised concerns during the public meeting regarding the adequacy of clinical trials. She noted that while TAP helps companies navigate the path to Medicare coverage, the underlying data often lacks representation of the very populations—such as the elderly and those with chronic disabilities—that Medicare serves. "If a device doesn’t have clinical trials that include people over the age of 65, it is very hard for Medicare to justify that device as reasonable and necessary," Zuckerman argued.
The Debate Over Real-World Evidence (RWE)
MDUFA VI also places a heavy emphasis on the expanded use of Real-World Evidence (RWE). This includes data derived from sources outside of traditional clinical trials, such as electronic health records (EHRs), insurance claims data, and information harvested from wearable health devices. The FDA intends to use RWE to support premarket submissions and to help recruit more representative patient populations for clinical studies.
While the industry generally supports the use of RWE as a tool to speed up the approval process, patient advocacy groups and digital health experts are pushing for a more balanced approach. Many argue that RWE is most valuable in the postmarket phase—after a device has been used by a broad, diverse population in everyday settings.
Benjamin Vandendriessche, chief scientific officer of the Digital Medicine Society, and Diana Zuckerman both called for the FDA to reconsider the weight given to RWE in the premarket phase. They argued that the "real world" nature of the data is only truly realized once a device is on the market. These advocates are concerned that an over-reliance on RWE before approval could lead to the clearance of devices based on less rigorous data than traditional clinical trials provide.
Industry Support and Broader Implications
Despite the debates over RWE and staffing, the medtech industry’s primary lobbying arm, AdvaMed, has signaled strong support for the MDUFA VI draft. Zach Rothstein, AdvaMed’s executive vice president of digital and diagnostics technologies, praised the agreement for maintaining stable fee levels for domestic firms and for its focus on strengthening existing programs.
The stability offered by MDUFA VI is seen as a vital component for the U.S. medtech sector, which has faced significant headwinds from global supply chain disruptions and inflationary pressures. By keeping fees flat for U.S. companies and making programs like TAP permanent, the agreement provides a predictable regulatory environment that is essential for long-term R&D investment.
However, the long-term implications of the higher fees for overseas firms remain to be seen. While the policy protects domestic interests, it could potentially lead to retaliatory fee increases from foreign regulators or discourage international startups from entering the U.S. market. This could, in turn, limit the variety of innovative technologies available to American patients.
As the FDA moves toward the January submission deadline, the focus will remain on balancing the industry’s need for speed and predictability with the public’s demand for rigorous safety oversight and postmarket accountability. MDUFA VI represents a middle-ground approach—an agreement that seeks to preserve the status quo of review performance while modernizing the financial and data-driven foundations of the agency.
