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
|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|