User Fee Requirements and Payment Process for 513(g) Requests for Information
This guidance explains the user fees requirements and payment process for 513(g) requests for information submitted to FDA. A 513(g) request is used to obtain information about device classification and applicable regulatory requirements.
Recommended Actions
- Check current fiscal year user fees on FDA MDUFA User Fees website
- Complete FDA Form 3601 (Medical Device User Fee Cover Sheet)
- Submit payment through one of three methods:
- Credit card/electronic check through pay.gov (preferred)
- Paper check with PIN number
- Wire transfer with PIN number
- Include copy of User Fee Cover Sheet with payment
- Ensure payment is received before submitting 513(g) request
- Keep PIN number for reference
- Do not submit payment with the application itself
- Plan for separate user fees if subsequent submissions (510(k), De Novo, PMA) will be needed
Key Considerations
Other considerations
- All 513(g) requests require payment of user fees with no exceptions
- User fees will not be refunded once FDA starts review, even if request is withdrawn
- New submissions (510(k), De Novo, PMA) following a 513(g) require separate user fee payments
- Adding new questions/uses/technologies to an existing 513(g) request requires a new submission with new user fee
- Responses to FDA requests for additional information do not require new user fees
- A Medical Device User Fee Cover Sheet (Form FDA-3601) must be completed and submitted
Relevant Guidances
- Medical Device User Fee Small Business Qualification and Certification Process
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (Draft)
- De Novo Classification Request User Fees and Refund Policies
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- User Fees and Refunds for 510k Submissions
Original guidance
This post is licensed under CC BY 4.0 by the author.