The Food and Drug Administration and the medtech industry are nearing an end to the latest round of medical device user fee negotiations.
The FDA and industry reached an “agreement in principle” on most proposals and have agreed to move forward with drafting commitment letter language, according to the latest meeting minutes, from March 18. Once a commitment letter is finalized, it goes to Congress for approval.
The medical device user fee amendments, or MDUFA, are renegotiated every five years and set how much funding the agency can raise from user fees. The next agreement, called MDUFA VI, will run from 2027 to 2032.
In the current commitment, MDUFA V, the medtech industry agreed to pay more in fees in exchange for the FDA’s device center to hire more than 500 employees. Following the mass cuts across the Department of Health and Human Services last year, which left the Center for Devices and Radiological Health understaffed and overworked, staffing transparency has been a part of the negotiations for the next agreement.
Medtech industry representatives asked the FDA to include language reflecting that funding to fulfill staffing levels agreed to under MDUFA V will continue in MDUFA VI. The FDA “acknowledged the shared intent to hire substantial numbers of additional review staff,” according to the meeting minutes.
The negotiations also included proposals on real world evidence and changes to establishment fees. Companies that make or distribute medical devices must register with the FDA each year and pay an establishment fee. The agency has proposed splitting device fees between foreign and domestic firms, with overseas companies paying a higher rate.
“The FDA is pushing an America-First approach in the user fee negotiations to ensure they support domestic medical device innovation, strengthen supply chains, and improve access to safe and effective technologies for American patients,” HHS spokesperson Andrew Nixon wrote in an emailed statement to MedTech Dive.
In the meeting minutes, the FDA said MDUFA VI includes marginal increases in staffing and operational expenses above the MDUFA V baseline. Most firms should see lower fees in fiscal year 2028, the agency added, due to changes in the statutory fee structure, with decreases to submission fees and domestic registration fees.
