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# CDRH Guidance on Small Business User Fees
- URL: https://www.fdaweb.com/cdrh-guidance-on-small-business-user-fees/
- Published: 2016-08-01T12:00:00.000Z
- Updated: 2026-09-14T21:20:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136349

CDRH has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514085.pdf?ref=fdaweb.com) on “FY 2017 Medical Device User Fee Small Business Qualification and Certification” that describes the process for requesting qualification and certification as a small business in order to allow reduced user fees. A small business designated company must have gross receipts or sales of no more than $100 million for the most recent tax year. “The establishment registration fee is not eligible for a reduced small business fee,” the guidance notes.