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# MDUFA Small Business Qualification Guide
- URL: https://www.fdaweb.com/mdufa-small-business-qualification-guide/
- Published: 2025-07-30T12:00:00.000Z
- Updated: 2026-09-14T15:17:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159592

FDA has published a guidance, *Medical Device User Fee Small Business Qualification and Determination*, describing the process for how a business may request a determination that it qualifies as a small business for the purpose MDUFA provisions about reduced fees for such businesses. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-determination?ref=fdaweb.com) says that a business that is qualified and determined by FDA to be a MDUFA “small business” is eligible for a substantial reduction in several application fees.

The guidance includes an Introduction, Overview, Small Business Fees and Waivers, Guidance for U.S. Businesses, Guidance for Foreign Businesses, Guidance for Foreign Governments — How to Prepare a National Taxing Authority Certification, Frequently Asked Questions, and Paperwork Reduction Act of 1995.