User Fees and Refunds for 510k Submissions
This guidance document outlines the requirements and processes related to user fees and refunds for 510(k) premarket notification submissions. It clarifies which types of 510(k)s are subject to user fees, exceptions to user fees, and circumstances that may result in refunds of paid user fees under MDUFA V (Medical Device User Fee Amendments of 2022).
Recommended Actions
- Verify if your submission qualifies for user fee exceptions before submitting
- Ensure proper payment method and include Payment Identification Number (PIN) with submission
- Submit valid eCopy or eSTAR meeting technical requirements to avoid delays and potential refund situations
- Review acceptance criteria thoroughly before submission to prevent refusal to accept
- Maintain compliance with response timeframes for additional information requests to avoid withdrawal
- Submit refund requests within 180 calendar days if eligible for refund
- Consider consulting FDA guidance on device modifications before submitting 510(k) for changes to existing devices
- For devices found NSE, carefully evaluate the appropriate next regulatory pathway (new 510(k), De Novo, or PMA)
- Verify device classification and exemption status before submitting 510(k)
- Consider using 513(g) process if uncertain about device classification or requirements
Key Considerations
Software
- eSTAR (electronic Submission Template And Resource) submissions must pass technical screening within 15 calendar days
- Failed eSTAR technical screening allows for refund if submission is withdrawn
Other considerations
- Most 510(k) submissions require user fees except for:
- Submissions reviewed by FDA-accredited third parties
- Devices intended solely for pediatric populations
- State/federal government entities for non-commercial devices
- Refunds are provided in specific cases:
- When statutory exceptions apply
- Failed eCopy or eSTAR submission before acceptance
- Failed acceptance criteria during review
- Failed eSTAR technical screening if withdrawn
- No refunds are provided:
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- MDUFA Performance Goals and Processing of 510k Submissions
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
Related references and norms
- 21 CFR parts 862-892: Medical Device Classification Regulations
- 21 CFR 807.81: When a 510(k) is Required
- 21 CFR 807.87(m): FDA Withdrawal Considerations
- 21 CFR 807.92(a)(3): Predicate Device Definition
Original guidance
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