FDA Publishes Proposed MDUFA VI Device User-Fee Recommendations

The FDA on Wednesday published its proposed recommendations for the next medical device user fee program, MDUFA VI, opening a 30-day comment period and scheduling a hybrid public meeting for August 5 at its White Oak campus in Silver Spring, Maryland.

The Federal Register notice covers fiscal years 2028 through 2032. The Medical Device User Fee Amendments let the FDA collect fees from manufacturers to fund the review of device applications. The current authorization, MDUFA V, expires September 30, 2027, after which new legislation is needed for the agency to keep collecting device user fees.

According to the notice, the FDA negotiated with two industry groups, the Advanced Medical Technology Association and the Medical Device Manufacturers Association, from October 2025 through March 2026, while holding monthly consultations with patient and consumer groups, health care professionals and academic experts. The agency said the recommendations remain subject to change until the final commitment letter is published. After the meeting and comment period it will revise them as necessary and present them to the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee.

Review goals and Pre-Submissions

The draft commitment letter largely keeps the review performance goals in place at the end of MDUFA V, including the decision goals for original premarket approval applications, 510(k)s and CLIA waiver applications. The FDA would keep reporting average total time to decision, with a shared outcome goal of 285 calendar days for original PMAs and panel-track supplements and a 510(k) goal that ramps down from 128 calendar days in fiscal 2028 to 112 days by fiscal 2032.

The Pre-Submission program, through which companies ask the agency for feedback before filing, would keep its goal of written feedback on at least 90% of requests within 70 days, for up to 5,000 submissions a year. MDUFA VI would add Focused Follow-Up Pre-Submissions, a faster type for targeted follow-up questions, answered within 45 calendar days. The FDA and industry also agreed to propose changing the law to charge a fee for initial Pre-Submissions, which sponsors would later recover as a credit on certain related marketing submission fees.

For De Novo requests, the goal of a decision on 90% of requests within 150 FDA days would stay. The draft adds an introduction meeting with the applicant within the first 30 FDA days and recognizes a "Not Grantable" letter, with a final decision due 75 to 90 calendar days after the applicant responds.

New programs

Among other proposals, the notice describes:

• A pilot in which the same device with the same intended use is submitted at the same time to the FDA and at least two other regulators, with results to be evaluated and published by September 30, 2030.
• A full Total Product Life Cycle Advisory Program covering all product areas by October 1, 2027, including focused work with the Centers for Medicare & Medicaid Services on technologies for which a new coverage determination would be beneficial.
• A review consistency commitment covering at least eight topics over five years, with industry proposing priorities each year.
• A survey of companies that receive deficiency letters, and a resource capacity planning function with an implementation plan due by March 31, 2029.

The notice also reports on the current program. The FDA said preliminary data through September 30, 2025 show it has met, or may still meet, all of its submission review goals for fiscal 2024 and 2025 that had enough submissions to measure. It completed 14 of 18 performance enhancement goals on time in fiscal 2025 and missed four.

People who want to attend the meeting must register by 4 p.m. on July 20, and requests to speak during the public comment session are due by 11:59 p.m. that day. The meeting will also be webcast.