Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration.
In a Feb. 4 meeting, medtech industry representatives proposed updates to Medical Device User Fee Amendments quarterly reporting to include staffing levels by office, according to meeting minutes. A week later, the FDA’s device center provided a counter proposal — offering center-level reporting instead. This approach is still under negotiation.
The Center for Devices and Radiological Health also agreed to a commitment to hire consistent with the agreement, according to Feb. 11 meeting minutes, the latest available on the FDA’s website. That commitment would use language similar to MDUFA IV, which did not tie user fee revenue to hiring performance through hiring incentives, unlike the current agreement. Industry groups supported these changes.
The MDUFA negotiations will determine how much funding the FDA’s device center can collect from the medtech industry over a five-year period, starting in October 2027. The FDA and industry are expected to send an agreement to Congress this year.
Staffing has been a key part of the negotiations as the current medical device user fee amendments, also known as MDUFA V, set funding incentives for the center to hire more people. Last year, the Trump administration cut thousands of employees from the FDA, bringing the future of the user fees into question.
The latest MDUFA quarterly report to include staffing information was for September 2024, the end of the FDA’s fiscal year, laying out the device center’s hiring efforts and total employees. The CDRH did not provide any staffing information in its 2025 annual report, a departure from previous years.
Updates on international fees
Another change being negotiated was how the FDA’s device center would levy fees on overseas medtech firms. The CDRH proposed splitting establishment fees between foreign and domestic firms, with overseas companies paying a higher rate. Companies that produce or distribute medical devices must register with the FDA each year and pay an establishment fee.
In response, medtech lobbyists called for the FDA to consider compliance with the United States-Mexico-Canada trade agreement as it sets fees, but the CDRH declined, according to the latest meeting minutes.
FDA proposes changes to spending trigger
Finally, the FDA proposed making changes to the appropriations and spending triggers for user fees. If the CDRH doesn’t meet these triggers, then it cannot spend collected user fees. There are two triggers intended to ensure user fees don’t overtake congressional appropriations. The first trigger requires Congress to reach a funding threshold for the CDRH, and the second requires the center to spend a specific amount of non-user-fee funding on device reviews and other activities.
The FDA proposed changes in December to both thresholds. The agency said the changes would standardize core elements across the user fee programs and correct technical issues with the provisions, according to Jan. 14 meeting minutes. Specifically, it would increase the threshold by which the spending trigger can be missed, and adopt an agency-wide appropriation trigger, instead of one specific to the CDRH. Industry groups opposed all of the changes except for the technical corrections.
The topic came up again in the Feb. 11 meeting. The FDA proposed changes to the appropriations trigger “to account for circumstances in which Congressional appropriations do not increase commensurate with the current provision.” Industry groups called for more clarity and planned to provide feedback in future meetings.
