On July 30, 2026, the U.S. Food and Drug Administration (FDA) officially published “Medical Device User Fee Rates for Fiscal Year 2027,” announcing the medical device user fee rates for Fiscal Year 2027 (FY2027), which runs from October 1, 2026, through September 30, 2027.
Under the latest fee schedule, the Annual Establishment Registration Fee for medical device establishments will increase to US$13,785 per year.
For companies that qualify for FDA Small Business Determination, the Premarket Notification 510(k) Fee will be US$7,163.
FDA — Medical Device User Fee Amendments (MDUFA) Fees
FY2026 vs. FY2027 Medical Device User Fees
| Fee Category | FY2026 | FY2027 | Increase | Increase (%) |
|---|---|---|---|---|
| Annual Establishment Registration Fee | $11,423 | $13,785 | +$2,362 | +20.7% |
| 510(k) Premarket Notification Fee | $26,067 | $28,653 | +$2,586 | +9.9% |
| 510(k) Small Business Fee | $6,517 | $7,163 | +$646 | +9.9% |
FY2026 vs. FY2027 Fee Comparison
The latest fee adjustment will affect medical device companies planning to enter the U.S. market, as well as companies that are already registered and operating in the United States.
Manufacturers should pay close attention to changes in annual establishment registration fees and product submission costs, and plan their FDA compliance budgets accordingly.
For companies preparing for U.S. market entry, these updated fees should be incorporated into regulatory cost estimates and annual compliance planning for FY2027.