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FDA Fiscal Year 2027 User Fee Rates Officially Take Effect!

Time：2026-10-16 10:58:53

Starting October 1, 2026, the US FDA has officially entered Fiscal Year 2027 (FY2027). The updated user fee schedule under MDUFA V (Medical Device User Fee Amendments of 2022) is now in force. Under this fiscal year update, all premarket submission fees have risen with inflation. Notably, the annual establishment registration fee has increased far more steeply than application fees. Manufacturers exporting medical devices to the US must pay close attention to payment rules, small business qualifications and payment workflows. Errors in fees or expired qualifications may result in rejected submissions, invalid registrations and disruptions to US market access.

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https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027

一、Core Medical Device User Fees for FY2027

Note: The annual establishment registration fee does not qualify for the standard 25% small business discount. FDA may grant waivers on a case-by-case basis only if the manufacturer demonstrates financial hardship; automatic reduction is not available.

Fee Item	FY2027 Standard Fee (USD)	FY2027 Small Business Fee (USD)
510(k) Premarket Notification	$28,653	$7,163
513(g) Classification Information Request	$8,596	$4,298
PMA, PDP, PMR, BLA (Premarket Approval Application)	$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
30-Day Notice	$10,188	$5,094
Annual Periodic Reporting Fee for Class III Devices	$22,286	$5,572

Background on Fee Increases：

Under MDUFA V, FDA applies a dual inflation adjustment mechanism based on compensation costs and CPI. As FDA met its performance targets, the Performance Improvement Adjustment was fully applied to the establishment registration fee, driving a much larger increase for establishment annual fees compared to submission fees.

二、Key Points for Small Business Determination (SBD)

To qualify for reduced small business user fees, companies must obtain MDUFA Small Business Determination (SBD). SBD status is valid for a single fiscal year only. FY2026 SBD expired on Sep 30, 2026. Manufacturers must re-apply for FY2027 SBD before submitting any applications for FY2027. The SBD package must be submitted to FDA no later than 60 days prior to the fee deadline. You must hold valid SBD approval before submission; otherwise you will be charged the full standard fee.

（一）Eligibility Thresholds

Combined with affiliated entities, total revenue in the most recent tax year ≤ USD 100 million: eligible for small business discounted submission fees.
Combined with affiliated entities, total revenue in the most recent tax year ≤ USD 30 million: may apply for full fee waiver for the first PMA/PDP/BLA.
Combined with affiliated entities, total revenue in the most recent tax year ≤ USD 1 million: exemption from annual establishment registration fee.
Annual establishment registration fee: no automatic small business discount. Waivers are granted only on a case-by-case basis when substantial financial hardship is proven to FDA.

（二）Documentation for Non-US Manufacturers

Official MDUFA small business determination application form
Official tax certificate issued by the tax authority in the manufacturer’s home country, stating revenue in local currency and USD, exchange rate and reporting period, with official seal
Tax documents for all affiliated entities
Signed statement by company representative or CFO listing all affiliates or confirming no affiliated entities

三、Practical Recommendations for Export Manufacturers

For companies planning submissions (510(k)/De Novo/PMA etc.) after Oct 1, 2026：

Evaluate SBD eligibility and complete FY2027 small business determination early; do not wait until the day of submission.
Generate the PIN in advance before submission, and complete full payment online whenever possible. Delays in wire transfer receipt may cause FDA to reject your application.
Fee applicability rule: the applicable fiscal year is determined by the later of two dates — FDA receipt of your submission AND Treasury confirmation of payment, not the shipment date of your dossier.

US Establishment Registration (for overseas manufacturers)：

FY2027 annual establishment fee: $13,785, no automatic small business discount. Budget accordingly.
Mandatory workflow: create order and obtain PIN/PCN via DFUF for payment before updating registration in FURLS. Do not reverse the sequence.
Validate US Agent validity and device listing information. Inactive registration may lead to customs detention of shipments.

四、Conclusion

MDUFA V will expire on September 30, 2027. The US Congress will then begin negotiations for MDUFA VI, which will bring changes to user fee rules for future fiscal years. We recommend continuous monitoring of official FDA announcements.If you need further support, please consult Wiselink.

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