Post

De Novo Classification Request User Fees and Refund Policies

This guidance document outlines the user fee requirements and refund policies for De Novo classification requests submitted to FDA. It clarifies when user fees apply, exceptions to user fees, and circumstances under which refunds may be issued. The guidance also incorporates MDUFA V process improvements.

  1. Determine if your De Novo request qualifies for a user fee exception
  2. Prepare user fee payment before submission using one of the approved methods:
    • Credit card/electronic check (preferred)
    • Paper check
    • Wire transfer
  3. Ensure submission includes:
    • Valid eCopy or eSTAR
    • Payment Identification Number (PIN)
    • User Fee Cover Sheet (Form FDA-3601)
  4. For eSTAR submissions:
    • Monitor technical screening results within 15 days
    • Be prepared to submit replacement if technical screening fails
  5. If seeking refund:
    • Submit written request within 180 days of fee payment
    • Include proper documentation to relevant FDA center
  6. Consider consulting FDA before submission through:
    • Division of Industry and Consumer Education (DICE) for CDRH
    • Manufacturers Assistance and Technical Training Branch (MATTB) for CBER
    • 513(g) Request for Information if needed

Key Considerations

Software

  • Electronic submissions using eSTAR must pass technical screening within 15 calendar days
  • Failed eSTAR technical screening will result in submission being placed on hold until complete replacement is submitted

Other considerations

  • 21 CFR 860.230: Procedures for accepting or refusing a De Novo request
  • 21 CFR 860.250: Withdrawal of a De Novo request
  • 21 CFR 860.260: Procedures for declining a De Novo request

Original guidance

  • De Novo Classification Request User Fees and Refund Policies
  • HTML / PDF
  • Issue date: 2022-10-05
  • Last changed date: 2022-10-06
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Premarket, User Fees
  • ReguVirta summary file ID: 674e74948f2e5113aad9142e0c013413
This post is licensed under CC BY 4.0 by the author.