Contract Manufacturer - Manufactures a finished device to another establishment's specifications and puts the device in commercial distribution.
Contract Sterilizer - Provides a sterilization service for another establishment's devices and puts the devices in commercial distribution.
Foreign Exporter – Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Initial Distributor/Importer - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Remanufacturer - Processes, conditions, renovates, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Reprocessor of Single Use Devices – Performs remanufacturing operations on a single use device.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
U. S. manufacturer of export only devices – Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
