MDUFA VI: The Negotiations Shaping the Future of US Medical Device Regulation Through 2032

Most regulatory professionals in the industry are familiar with the user fee amounts but don't know what's behind them. MDUFA VI is not just another fee update. It's the agreement that will dictate how quickly the FDA reviews 510(k)s, what makes it onto the guidance agenda, and what the CDRH will look like in 2028-2032. The negotiations are happening now.

When you mention MDUFA to regulatory professionals, the common response is one of two things: 'Oh, that's the fee you pay for a 510(k), or a blank stare. Few can explain what MDUFA truly determines, and why the current reauthorization process is worth following even if you don't work for the FDA or as a lobbyist in Washington.

Here’s what's important to know: user fees have grown from about 20% of the FDA's budget in 2007 to nearly 49% in 2025. Almost half of the FDA’s capacity to review medical device submissions is funded by the industry itself. And every five years, the FDA and the industry sit down to negotiate what they get in return: how quickly submissions will be reviewed, which programs will be developed, and what actions the FDA commits to undertake.

This is a process that directly impacts every company submitting a PMA, De Novo, 510(k), or pre-submission, and MDUFA VI is already underway.

What is MDUFA and Why Does It Exist

In the 1980s and early 1990s, before the user fee program, companies would submit an application to the FDA and wait. Commissioner Makary recently described finding large boxes of paper applications simply sitting unprocessed in FDA warehouses. To solve this problem, the FDA was granted the authority to collect fees from the industry to fund dedicated review teams and commit to a timeline.

MDUFA V is the current version, in effect from October 1, 2022, to September 30, 2027. MDUFA VI is the next iteration, which will cover the years 2028-2032.

The Negotiations: What's Happening Now

Meetings between the FDA and industry representatives began on September 11, 2025, and continued through February 2026. Consultation meetings with stakeholders started on October 27, 2025, and the FDA and the medical device industry concluded negotiations and began drafting the agreement in March 2026.

The law requires the HHS Secretary to submit the user fee agreements to Congress no later than January 15, 2027. Afterward, Congress is expected to deliberate and approve the legislation before MDUFA V expires in September 2027.

What's on the table? Recent meetings have focused on ways to streamline the review process, setting fees to fund upgrades to the agency's IT systems, and making changes to the De Novo and pre-submission programs. Additionally, discussions have revolved around post-market surveillance, balancing speed of approval with safety, and the TAP 2.0 program.

The FDA and industry have reached an agreement in several key areas, including using future fees to fund IT system upgrades and changes to the De Novo and pre-submission programs.

Why This Matters to You, Even If You're Not American

For international companies planning to enter the US market, MDUFA VI will directly shape the regulatory landscape they will navigate from 2028-2032. Here are a few things the negotiations could determine:

  • 510(k) Review Timeline: Each MDUFA sets review time goals. Under MDUFA V, the FDA committed to completing 95% of 510(k) reviews within 90 days. MDUFA VI could adjust these targets upward or downward, depending on the outcome of negotiations and the resources allocated. If the FDA commits to a shorter timeline, it will directly impact market entry planning.

  • Q-Submission and Pre-Sub Programs: The pre-submission program was significantly expanded under MDUFA V. MDUFA VI may bring further changes, including an upgrade of the TAP (Total Product Life Cycle Advisory Program) to TAP 2.0, which is designed to provide earlier and more in-depth FDA engagement during the development process.

  • Guidance Agenda: Part of MDUFA is the FDA's commitment to publish specific guidance documents on agreed-upon topics. If topics like AI, cybersecurity, and real-world evidence are included in the agreement as committed deliverables, they will be prioritized for publication. If not, they will remain on the 'waiting list.'

  • Fees: Under MDUFA V, the 510(k) fee increased by 55.9%—from $12,745 to $19,870. MDUFA VI will set the fee amounts for 2028-2032. In an era where CDRH has experienced staffing losses and faces pressure to streamline, it's an open question whether fees will increase, decrease, or become more flexible for small businesses.

The Connection to the Broader Trump Administration Reforms

MDUFA VI is taking place against a backdrop of changes at the FDA unlike any we have seen in a long time. Commissioner Makary has promoted a message of 'getting out of the way,' CDRH has experienced budget and staffing cuts, and there is political pressure to shorten timelines and increase efficiency.

The FDA itself acknowledged in its 2026 MDUFA V performance report that in FY2025, it underwent budget cuts and organizational changes that impacted planned staffing levels, and that the agency maintained performance by re-prioritizing tasks and using external contractors.

On February 17, 2026, the Ranking Member of the Senate HELP Committee, Bill Cassidy, released a report titled 'Patients and Families First: Building the FDA of the Future'. The report emphasizes the need for more consistent and stable review processes, reducing the burden of clinical trials, and accelerating treatments for rare diseases. These are the themes expected to resonate in the congressional debates over MDUFA VI.

What to Watch for in the Coming Months

March-April 2026: An initial agreement between the FDA and industry on MDUFA VI is expected. This will be a published 'commitment letter.'

May-September 2026: Publication of the draft recommendations in the Federal Register, a 30-day public comment period, and a public meeting.

January 2027: Formal submission deadline to Congress.

2027: Congressional hearings and approval - expected before September 30, 2027.

October 1, 2028: MDUFA VI goes into effect.

In Conclusion

MDUFA VI is one of the least understood yet most impactful regulatory mechanisms affecting medical device companies. It's not a new guidance or law, but a five-year agreement between the FDA and industry that defines how quickly you'll receive a decision on your 510(k), which topics the FDA will issue guidance on, and the staffing levels with which CDRH will operate.

In an era where FDA timelines, fees, and service levels are at the center of the debate, it's worth understanding and following this process. The commitment letter to be released in the coming months will reveal a great deal about the direction the FDA is heading toward 2030.