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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the new small business registration fee waiver under FDORA 2022?
Starting in fiscal year 2025, FDA can waive establishment registration fees for small businesses (≤$1M gross receipts) experiencing financial hardship. Currently, FDA only recognizes active bankruptcy as meeting the clear, objective standard for financial hardship demonstration.
How do foreign businesses without a National Taxing Authority qualify for small business benefits?
Foreign businesses in jurisdictions without a National Taxing Authority can submit alternative evidence like fiscal year financial statements or shareholder reports showing gross sales/receipts below $1M. FDA reviews these submissions case-by-case for qualification.
Can small business fee waivers or reductions be transferred to other entities?
No, small business qualifications are not transferable. If a small business is acquired, the acquiring entity must obtain its own small business determination. Third-party consultants submitting applications on behalf of clients cannot use the client’s small business status.
What documentation is required for U.S. businesses seeking registration fee waivers?
U.S. businesses must provide: recent federal tax returns showing ≤$1M gross receipts, evidence of previous FDA registration and paid fees under their owner/operator ID, and proof of active bankruptcy filing in U.S. Bankruptcy Court.
How frequently can a business receive the small business registration fee waiver?
FDA does not intend to grant the registration fee waiver repeatedly to the same entity for the same circumstances that initially qualified them. The waiver is designed for specific financial hardship situations, not ongoing relief.
What is the timeline for submitting small business registration fee waiver requests?
Applications for small business registration fee waivers must be submitted at least 60 days before the fee is due. FDA’s decision on whether to grant the waiver is final and not subject to review or appeal.
What You Need to Do 👇
Recommended Actions
- Review your company’s gross receipts or sales to determine if you qualify as a small business ($1,000,000 or less)
- If in bankruptcy, gather required documentation:
- Most recent tax returns
- Evidence of previous registration and paid fees
- Active bankruptcy documentation
- For foreign companies, prepare equivalent documentation from your jurisdiction
- For companies in jurisdictions without NTA, prepare alternative financial evidence (e.g., financial statements, shareholder reports)
- Submit waiver request at least 60 days before fee is due
- Maintain records of all submissions and approvals
- 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