Your 510(k) gets more expensive on October 1.

The bigger jump comes in 2027.

FDA published the FY2027 medical device user fee rates on July 30. Starting October 1, 2026, a 510(k) premarket submission will cost $28,653, while the small business fee is $7,163, and the annual establishment registration runs $13,785 per entity with no small business reduction. If you are building a submission budget for next year, those are the numbers to use.

Now look one year further out. MDUFA V, the current authorization of the Medical Device User Fee Amendments, sunsets on September 30, 2027. Every dollar FDA collects after that date depends on Congress passing MDUFA VI. And if the last two reauthorizations tell us anything, what you pay in FY2028 will not look like a routine inflation bump.

How the five-year cycle actually sets your fee

Inside a MDUFA cycle, the math is boring by design. Statute fixes a base revenue amount for each fiscal year, FDA applies an inflation adjustment, and the published rates fall out of that. MDUFA V layered on a few additional adjustments for performance improvement, hiring, and operating reserves, but the ceiling is set in law and the year-to-year movement is largely predictable.

Reauthorization is where the base itself gets rewritten. FDA and industry negotiate a new commitment letter, new performance goals get attached to new funding, and Congress sets a new statutory revenue target. That target is not anchored to the prior year's number.

You can see it clearly in two data points.

FY2018, the first year of MDUFA IV. The standard 510(k) fee went from $4,690 to $10,566, a 125 percent increase in one year. Establishment registration went from $3,382 to $4,624, up 36.7 percent.

FY2023, the first year of MDUFA V. The standard 510(k) fee went from $12,745 to $19,870, up 55.9 percent. Establishment registration climbed 14.5 percent.

Two cycles, two step changes, both landing in the first October after reauthorization. FY2028 begins October 1, 2027.

The slow climb underneath

Reauthorization years get the attention because the percentages are dramatic. The ordinary years are what quietly reshape a budget, because they compound.

Over seven years, establishment registration is up 163 percent and the 510(k) fee is up 147 percent. General consumer inflation over the same stretch was a fraction of that. A company that registered one facility and filed one small business 510(k) paid $8,135 in FY2020. The same two line items cost $20,948 in FY2027.

Registration deserves a second look, because it has outrun submission fees every year since FY2023 and the reason is structural. MDUFA V permits FDA to apply the performance improvement, hiring, and operating reserve adjustments to registration fees only. In FY2027 the performance improvement adjustment alone added $63.5 million, all of it loaded onto registration. That is why registration jumped 20.7 percent this year while the 510(k) fee moved 9.9 percent. If you run several registered establishments, contract manufacturers included, that line item is growing faster than anything else on your regulatory budget.

What a lean team should do with the next thirteen months

A little over thirteen months is enough time to change the outcome. It is not enough time to build a design and development file from scratch.

Extend your submission roadmap through FY2029. List every 510(k), De Novo request, and PMA supplement you expect to file between now and then. Anything penciled in for late FY2027 or early FY2028 is sitting right on the seam. Ask what would have to be true to file it before September 30, 2027, and what that costs in engineering time. Sometimes the fee difference does not justify compressing design and development verification and validation. Sometimes it clearly does, and nobody has run the comparison.

Requalify for small business status now, not next summer. Small business determination expires September 30 every fiscal year and does not roll over. FDA began accepting FY2027 requests on August 1, 2026, using Form FDA 3602N with your federal tax returns, and foreign affiliates need Section III certified by their national taxing authority. On one standard 510(k), that certificate is worth $21,490. Teams lose it every year by treating it as a submission task instead of a fiscal-year task.

Audit your establishment registration list. Registration is billed per establishment, per year, at full rate regardless of company size. Any facility that no longer manufactures, sterilizes, relabels, or otherwise handles finished devices should not be carrying a $13,785 annual charge. That is a thirty minute review that pays for itself.

Get your documentation gaps on paper. Fee timing only matters if you can actually submit, and the thing that delays a 510(k) is rarely the payment. Since the Quality Management System Regulation (QMSR) took effect on February 2, 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference, and 820.3 no longer defines the design history file. What most teams still call the DHF is the design and development file under Clause 7.3.10. Whatever you call it in conversation, we often see teams held up by design validation that never closed, a risk file under ISO 14971 that does not trace back to design and development inputs, or software lifecycle documentation under IEC 62304 assembled after the code was written. Those take months to resolve, which is precisely the window in front of you.

Read the draft MDUFA VI commitment letter. FDA published its proposed recommendations for FY2028 through FY2032 and held a public meeting on August 5, 2026. The negotiated goals shape both what you pay and what review performance you get in return. If your team has a view on review timelines, this is the cycle where saying so counts.

The question to bring to your next planning meeting

Which submissions on our roadmap can realistically be filed before September 30, 2027, and what would it take to move them?

That question has a real answer, and it is worth having well before the FY2028 rates publish next July. By then the decision has been made for you.

If your team is sequencing submissions against the MDUFA calendar and wants a second read on what is genuinely ready to file, we would be glad to walk through it with you.