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USA Medical Device Registration Fees
FDA government fees for 2025
USD 9,280
Low Risk Min
USD 33,615
High Risk Max
FDA
Authority
2025-09-17
Last Updated
USA (FDA) Fee Overview
The FDA charges annual establishment fees of $9,280 per facility, plus submission-specific fees. 510(k) clearance costs $24,335 (or $6,084 for small businesses). De Novo classification is significantly higher at $162,235 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 | $9,280 | Annual per facility |
510(k) Review - Standard Class II typically | $24,335 | Per submission |
510(k) Review - Small Business FDA-qualified small businesses | $6,084 | Per submission |
De Novo Review - Standard | $162,235 | Per submission |
De Novo Review - Small Business | $40,559 | Per submission |
Key Facts About FDA Fees
- 1Annual establishment fee: $9,280 per facility
- 2510(k) standard fee: $24,335 per submission
- 3Small business discount: 75% (must qualify)
- 4De Novo: $162,235 (complex path for novel devices)
- 5No per-product registration fees
Important Notes
- •Annual establishment fee: $9,280/year (facility-level)
- •510(k) review: $24,335 standard / $6,084 small business
- •De Novo review: $162,235 standard / $40,559 small business
- •Fees are manufacturer-level, not per product
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: 2025-09-17. Always verify current fees with FDA.