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.
What You Need to Know? 👇
What types of PMA applications are subject to user fees under MDUFA V?
Under MDUFA V, user fees apply to Original PMAs, Modular PMAs, Premarket Reports, Licensing Agreement PMAs, Panel-Track Supplements, 180-Day Supplements, Real-Time Supplements, 30-Day Notices, and Periodic Reports submitted on or after October 1, 2022.
Are there any exceptions to paying user fees for medical device submissions?
Yes, PMAs or BLAs intended solely for pediatric populations are exempt from user fees. First-time submissions by qualifying small businesses (under $30 million gross receipts) receive a one-time waiver. Government entities are also exempt unless distributing commercially.
When can I request a refund of my PMA user fee?
Refunds are available in specific circumstances: 75% refund if withdrawn before filing or if not-filed; partial refunds (50%, 25%, or none) based on review duration if withdrawn after filing but before first action; no refund after FDA’s first action.
What payment methods are accepted for medical device user fees?
FDA accepts three payment methods: online credit card or electronic check through pay.gov (preferred), paper checks mailed to specified P.O. Box, or wire transfers. All payments must include the Payment Identification Number (PIN) from your User Fee Cover Sheet.
How are BLA efficacy supplements different from other BLA supplements for user fee purposes?
BLA efficacy supplements require substantive clinical data forming the primary basis for approval and are subject to user fees. Other BLA supplements like Prior Approval Supplements, Changes Being Effected, and Annual Reports that don’t meet efficacy supplement criteria are not subject to fees.
What happens if I don’t submit a valid eCopy with my submission?
If you don’t provide a valid eCopy or it doesn’t meet technical standards, FDA will notify you in writing. You have 180 calendar days to submit a valid replacement eCopy. If not provided within this timeframe, your submission will be deleted and fees refunded upon request.
What You Need to Do 👇
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:
- Timing of withdrawal request
- Stage of review process
- Type of submission
- Level of effort already expended by FDA
Relevant Guidances 🔗
- 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