FDA Outsourcing Facility User Fee Rates: Fiscal Year 2019

FDA 2019 Outsourcing Facility User Fee Rates

According to a recently released notice from the FDA, “the FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility.” Fees increased slightly between FY 2018 and FY 2019. These updated fee rates will be effective October 1, 2018 through September 30, 2019.

The new user fee rates are as follows:

Fee Category FY 2019 Fee Rates FY 2018 Fee Rates
Qualified Small Business Establishment Fee $5,461 $5,364
Non-Small Business Establishment Fee $18,375 $17,364
Re-inspection Fee $16,382 $16,093


We are qualified and have helped many facilities with the FDA registration process in the past. Contact us today to learn more about how we can help your facility register and reduce the total cost to do so.