This resource is the US FDA (Food and Drug Administration) guidance on paying user fees and obtaining refunds for 510(k) premarket notification submissions.
About this document
The guidance explains which 510(k) submissions require a user fee, when the fee must be paid, the reductions available with a Small Business Determination (SBD), and the conditions for refunds when a submission is refused, withdrawn or not accepted. The amounts for each fiscal year are those in the fee schedule published by the FDA for that year.
Applicable products and users
- Medical device manufacturers submitting 510(k)s to the FDA
- Companies wishing to apply for small business fee reductions
Main contents
- Types of 510(k) that require or are exempt from fees
- Small Business Determination (SBD) and fee reductions
- Refund rules for refused or withdrawn submissions
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Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.