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:
||FY 2019 Fee Rates
||FY 2018 Fee Rates
|Qualified Small Business Establishment Fee
|Non-Small Business Establishment Fee
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.