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USA Medical Device Registration Fees
FDA government fees for 2026
USD 11,423
Low Risk Min
USD 37,490
High Risk Max
FDA
Authority
2026-01-12
Last Updated
USA (FDA) Fee Overview
The FDA charges annual establishment fees of $11,423 per facility, plus submission-specific fees. 510(k) clearance costs $26,067 (or $6,517 for small businesses). De Novo classification is significantly higher at $173,782 standard. Unlike many countries, FDA fees are facility-based, not per-product, making it cost-effective for manufacturers with large product portfolios.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Annual Establishment Registration | $11,423 | Annual per facility |
510(k) Review - Standard Class II typically | $26,067 | Per submission |
510(k) Review - Small Business FDA-qualified small businesses | $6,517 | Per submission |
De Novo Review - Standard | $173,782 | Per submission |
De Novo Review - Small Business | $43,446 | Per submission |
Key Facts About FDA Fees
- 1Annual establishment fee: $11,423 per facility
- 2510(k) standard fee: $26,067 per submission
- 3Small business discount: 75% (must qualify)
- 4De Novo: $173,782 (complex path for novel devices)
- 5No per-product registration fees
Important Notes
- •Annual establishment fee: $11,423/year (facility-level)
- •510(k) review: $26,067 standard / $6,517 small business
- •De Novo review: $173,782 standard / $43,446 small business
Tips for USA Registration
- 1Apply for FDA Small Business Qualification before your first submission
- 2Annual establishment fee is due October 1 each fiscal year
- 3Third-party 510(k) review has no FDA fee
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2026-01-12. Always verify current fees with FDA.