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.
What You Need to Know? 👇
What is the gross receipts threshold for MDUFA small business qualification?
To qualify as a small business under MDUFA, your business and all affiliates combined must have gross receipts or sales of no more than $100 million for the most recent tax year.
How long does FDA take to review a Small Business Certification Request?
FDA will review your Small Business Certification Request within 60 calendar days of receipt and send you a decision letter indicating whether your business qualifies as a small business.
Can foreign businesses qualify for MDUFA small business status without filing US tax returns?
Yes, foreign businesses can qualify by obtaining a National Taxing Authority Certification from their country’s tax authority instead of filing Federal US income tax returns, using Form FDA 3602A.
What is the “first premarket application” fee waiver and who qualifies?
Businesses with gross receipts under $30 million that have never submitted a PMA, BLA, PDP, or PMR can receive a complete fee waiver for their first premarket application/report submission.
When does my small business certification expire and how do I renew it?
Small business certification expires at the end of the fiscal year (September 30) for which it was granted. You must submit a new certification request each year to maintain status.
What happens if I submit an application before receiving small business qualification?
You must pay the standard full fee if you submit before qualification. FDA will not refund the difference between standard and small business fees if you later qualify as a small business.
What You Need to Do 👇
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 đź”—
Related references and norms đź“‚
- 21 CFR 11.3: Electronic Records; Electronic Signatures