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FY2027 FDA Medical Device User Fees Finalized: MDUFA V’s Final Year and What You Need to Know

Writer: Provision Consulting Group
Provision Consulting Group
Aug 24
2 min read
FY2027 FDA medical device user fees

Companies preparing to enter the US medical device market should take note of a recent FDA announcement.

FDA has finalized the FY2027 medical device user fees in the Federal Register. The new rates run from October 1, 2026 through September 30, 2027.

On the surface, this looks like a routine annual notice. It isn't quite that simple. The current fee framework, MDUFA V (2023-2027), closes out with this fiscal year.

FDA user fees don't stay fixed indefinitely — Congress renegotiates them with industry in five-year cycles. That's held true since MDUFA I, and starting in 2028, MDUFA VI will set the new baseline. FY2027's numbers are, in effect, the last ones under the current agreement. If you're preparing a submission now, it's worth checking your budget against this year's table before anything changes.


If you're working through a 510(k) or PMA submission, revisit your budget and filing timeline against the FY2027 fee schedule now — it's the difference between planning for the cost and absorbing a surprise later.


Application Fees

Application Type

Standard Fee

Small Business Fee†

510(k)‡

$28,653

$7,163

513(g)

$8,596

$4,298

PMA, PDP, PMR, BLA

$636,732

$159,183

De Novo Classification Request

$191,020

$47,755

Panel-track Supplement

$509,386

$127,347

180-Day Supplement

$95,510

$23,878

Real-Time Supplement

$44,571

$11,143

BLA Efficacy Supplement

$636,732

$159,183

30-Day Notice

$10,188

$5,094

Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)

$22,286

$5,572



Small Business Fee Reductions Aren't Automatic

Companies with annual revenue under $100 million pay just 25% of the standard fee, and those under $30 million can have their first PMA fee waived entirely. Here's the catch: Small Business Determination isn't granted automatically when you file.

  • File 60 days out: You'll need to submit a separate small business application to FDA — with tax and financial documentation — at least 60 days before your regulatory submission, and get it approved first.

  • Renew annually: Small business status has to be re-approved every fiscal year.

  • No retroactive fixes: Miss the 60-day window and your filing goes in at the standard rate. Even if you're approved as a small business later, you won't get the difference refunded.

If you have more than one submission in the pipeline, "small business application — 60 days out" should be the first thing on your calendar.



Getting Ready for the MDUFA VI Era

FY2027 is the closing chapter of MDUFA V, which means this fee table is about to be replaced by the outcome of the next round of negotiations. MDUFA VI talks are already underway, and the direction so far favors consistency in device review over speed.

Read more: MDUFA VI: FDA Device Review Isn't Getting Faster — It's Getting Stricter

If you're mapping out a development timeline that spans multiple fiscal years, it's worth tracking the MDUFA VI negotiations alongside this year's fee schedule.



Need help assessing small business eligibility, building your FY2027 budget, or setting a 510(k) filing timeline? Reach out to Provision Consulting Group anytime.






FY2027 FDA medical device user fees

For inquiries or expert assistance, please contact us today.




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