Post

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.

  1. Determine if your submission requires a user fee based on submission type and any applicable exceptions
  2. Calculate appropriate fee amount based on current fiscal year rates
  3. Submit payment through one of three methods:
    • Credit Card/Electronic Check (preferred)
    • Paper Check
    • Wire Transfer
  4. Include proper documentation with payment:
    • Payment Identification Number (PIN)
    • User Fee Cover Sheet (Form FDA-3601)
  5. 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
  6. Maintain awareness of timing implications for potential refunds based on review stages
  7. For modular PMAs, plan fee payment at first module submission
  8. For periodic reports, budget for annual fees after initial PMA approval
  9. Consider timing of withdrawal requests if needed to maximize potential refund amount
  10. Ensure proper eCopy submission to avoid delays and potential refund situations

Key Considerations

Other considerations

  • 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

  • User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
  • HTML / PDF
  • Issue date: 2022-10-05
  • Last changed date: 2022-10-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, User Fees, Biologics
  • ReguVirta summary file ID: 1e272a33fba9e7bf22b186325bf0cdbc
This post is licensed under CC BY 4.0 by the author.