Free tool
FDA fee calculator
Every fee FDA will charge for FY2027, taken from the Federal Register tables.
FY2027: 91 FR 48134
From 1 October 2026
$28,653
- Standard
- $28,653
- Small business
- $7,163
FY2027 · 91 FR 48134
A Small Business Determination would cut the FY2027 fee to $7,163 — a saving of $21,490. Threshold: $100 million in gross receipts including affiliates. Applying for the determination itself is free. How the determination works
| Also budget | Amount |
|---|---|
| Establishment registration, each year | $13,785 · no small business rate |
| Pre-Submission (Q-Sub) | No FDA fee |
| Third Party Review | No FDA fee — the Review Organization sets and charges its own, by agreement |