FDA medical device user fees for fiscal year 2027 took effect on October 1, 2026, and apply through September 30, 2027. Manufacturers planning U.S. submissions should review their budgets against the current fee schedule.
Selected fees are listed below. All amounts are in U.S. dollars.
| Submission type | Standard fee | Qualified small business fee |
|---|---|---|
| 510(k) premarket notification | $28,653 | $7,163 |
| De Novo classification request | $191,020 | $47,755 |
| Premarket approval application (PMA) | $636,732 | $159,183 |
The annual establishment registration fee is $13,785.
Small business qualification requires planning
Reduced application fees are available to businesses that receive FDA small business qualification. For reduced application and report fees, the eligibility threshold is generally $100 million or less in gross receipts or sales, including affiliates, for the most recent tax year.
Qualification is not automatic. Companies should review the documentation requirements and obtain FDA’s determination before relying on reduced fees.
The annual establishment registration fee does not receive the same small business discount. A separate waiver may be available to certain qualifying businesses that demonstrate financial hardship; it excludes initial registration.
AVRA’s perspective: connect the budget to the technical plan
We recommend reviewing regulatory budgets alongside the proposed submission pathway and the evidence needed to support it. A useful planning exercise brings together three questions:
- Which regulatory pathway fits the device and its intended use?
- What documentation and testing still need to be completed?
- Does the budget account for applicable FDA fees and the work required to prepare the submission?
This helps teams connect financial planning with realistic development milestones.
AVRA Medical Consulting supports medical-device organizations with regulatory readiness, technical documentation, and quality-system preparation.
Planning your next regulatory project? Contact us at contact@avramed.us.
Sources: FDA — FY 2027 Medical Device User Fees · FDA — Small Business Determination Program