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Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (DRAFT)

This guidance proposes updates to the Medical Device User Fee Small Business Qualification and Certification guidance, focusing on two main aspects: 1. How small businesses can demonstrate financial hardship to qualify for registration fee waivers 2. How applicants from jurisdictions without a National Taxing Authority can qualify for fee waivers or reductions

This is a draft guidance. Not for implementation.

  1. Review your company’s gross receipts or sales to determine if you qualify as a small business ($1,000,000 or less)
  2. If in bankruptcy, gather required documentation:
    • Most recent tax returns
    • Evidence of previous registration and paid fees
    • Active bankruptcy documentation
  3. For foreign companies, prepare equivalent documentation from your jurisdiction
  4. For companies in jurisdictions without NTA, prepare alternative financial evidence (e.g., financial statements, shareholder reports)
  5. Submit waiver request at least 60 days before fee is due
  6. Maintain records of all submissions and approvals
  7. Plan for future registration fees as waivers are not intended to be granted repeatedly

Key Considerations

Other considerations

  • Small business qualification: Gross receipts or sales of $1,000,000 or less in most recent Federal income tax return
  • Financial hardship demonstration:
    • Must be shown by clear and objective standard
    • Currently only active bankruptcy qualifies
    • Must provide evidence of prior paid registration fees
    • Must submit supporting information at least 60 days before fee is due
  • For foreign businesses:
    • Must provide equivalent bankruptcy documentation from their jurisdiction
    • Jurisdictions without NTA can submit alternative financial evidence
  • Fee waivers are not transferable between entities
  • FDA’s decision on registration fee waiver is not reviewable
  • FDA does not intend to grant repeated waivers for the same circumstances

    Relevant Guidances

  • Medical Device User Fee Small Business Qualification and Certification Process

Original guidance

  • Medical Device User Fee Small Business Qualification and Financial Hardship Waivers
  • HTML / PDF
  • Issue date: 2024-02-22
  • Last changed date: 2024-02-21
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, User Fees
  • ReguVirta summary file ID: 503bfc43d90acdefdcf9e2dda9692d75
This post is licensed under CC BY 4.0 by the author.