Are you required to pay a fee to the FDA?

Is your company required to pay a fee to the FDA? This chart details your requirements, based on the type of activity at a company.

Activity of Company Register COMPANY
and PRODUCT
with FDA?
Fee?
Finished device manufacturer YES YES
Custom device manufacturer YES YES
Manufacturer of accessories or components that are packaged and labeled for commercial distribution to an end user YES YES
Manufacturer of components distributed only to finished device manufacturer NO NO
Relabeler or repackager YES YES