Medical Device User Fee Small Business Qualification and Certification Process
This guidance outlines the process for businesses to request qualification and certification as a small business under the Medical Device User Fee Amendments (MDUFA), which allows eligible businesses to pay reduced fees for most medical device applications. The guidance applies to both U.S. and foreign businesses.
Recommended Actions
- Determine business eligibility based on gross receipts threshold ($100 million)
- For U.S. businesses:
- Complete Form FDA 3602
- Gather most recent Federal tax returns
- Include affiliate information if applicable
- For foreign businesses:
- Complete Form FDA 3602A
- Obtain certification from National Taxing Authority
- Include documentation for all affiliates
- Submit application package to FDA:
- Include all required forms and supporting documentation
- Ensure Organization ID number is correct
- Submit at least 60 days before needed
- Maintain records of small business certification and renewal:
- Track expiration date (end of fiscal year)
- Plan for annual renewal
- Keep Small Business Decision number for reference
- Monitor compliance:
- Ensure accuracy of all submitted information
- Report any changes in business status
- Maintain proper documentation of all submissions
Key Considerations
Other considerations
- Eligibility criteria: Gross receipts or sales must not exceed $100 million for the most recent tax year
- Small business certification is valid for one fiscal year only (October 1 through September 30)
- Different requirements for U.S. and foreign businesses:
- U.S. businesses must submit Form FDA 3602 with Federal income tax returns
- Foreign businesses must submit Form FDA 3602A with National Taxing Authority certification
- First premarket application fee waiver available for businesses with gross receipts under $30 million
- All affiliates’ gross receipts must be included in the calculation
- False certification may result in suspension of small business status and legal consequences
Relevant Guidances
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (Draft)
Related references and norms
- 21 CFR 11.3: Electronic Records; Electronic Signatures
Original guidance
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