User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
This guidance outlines the types of PMAs and BLAs subject to user fees, exceptions to user fees, and conditions for user fee refunds under MDUFA V. It applies to premarket approval applications (PMAs) and certain biologics license applications (BLAs) received on or after October 1, 2022.
Recommended Actions
- Determine if your submission requires a user fee based on submission type and any applicable exceptions
- Calculate appropriate fee amount based on current fiscal year rates
- Submit payment through one of three methods:
- Credit Card/Electronic Check (preferred)
- Paper Check
- Wire Transfer
- Include proper documentation with payment:
- Payment Identification Number (PIN)
- User Fee Cover Sheet (Form FDA-3601)
- For refund requests:
- Submit within 180 calendar days after fee was due
- Send written request to appropriate FDA center
- Include justification based on applicable refund criteria
- Maintain awareness of timing implications for potential refunds based on review stages
- For modular PMAs, plan fee payment at first module submission
- For periodic reports, budget for annual fees after initial PMA approval
- Consider timing of withdrawal requests if needed to maximize potential refund amount
- Ensure proper eCopy submission to avoid delays and potential refund situations
Key Considerations
Other considerations
- Different types of submissions are subject to user fees: Original PMAs, Modular PMAs, Premarket Reports, Licensing Agreement PMAs, Panel-Track Supplements, 180-Day Supplements, Real-Time Supplements, 30-day Notices, and Periodic Reports
- For BLAs: Original BLAs and BLA Efficacy Supplements are subject to fees
- Exceptions to user fees include:
- PMAs/BLAs intended solely for pediatric populations
- First PMA/BLA from small businesses (gross receipts ≤$30M)
- BLAs for products licensed for further manufacturing use only
- Government entities (if not commercially distributed)
- Refund conditions vary based on:
- User Fees and Refunds for 510k Submissions
- Medical Device User Fee Small Business Qualification and Certification Process
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (Draft)
Related references and norms
- 21 CFR 814.20: Application for Premarket Approval
- 21 CFR 814.39: PMA Supplements
- 21 CFR 814.82: Post-approval requirements
- 21 CFR 601.12: Changes to an approved application
- 21 CFR 601.2: Applications for biologics licenses
Original guidance
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