Do You Need To Register With The US FDA?
The following table shows which companies related to the medical device industry must register their product and/or company on the US FDA website and pay appropriate fees every year. If you are not sure if you need to register your company or medical device with the FDA, download our free PDF chart that explains the FDA 510(k) clearance process.
|Activity of company||Register COMPANY
to the FDA?
|Finished device manufacturer – domestic or foreign||YES||YES|
|Manufacturer of components that are distributed only to a finished device manufacturer – domestic or foreign||NO||NO|
|Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user – domestic||YES||YES|
|Custom device manufacturer – domestic or foreign||YES||YES|
|Contract manufacturer whose device is shipped to U.S. by the contract manufacturer - foreign||YES||YES|
|Contract sterilizer who commercially distributes the device – domestic||YES||YES|
|Contract sterilizer who does NOT commercially distribute the device – domestic||NO||NO|
|Contract sterilizer whose sterilized device is shipped to U.S. by the sterilizer - foreign||YES||YES|
|Initial distributor/importer – domestic||YES*||YES|
|Relabeler or repackager – domestic or foreign||YES||YES|
|Kit assembler – domestic or foreign||YES||YES|
|Domestic distributor – domestic||NO||NO|
|Specification developer – domestic or foreign||YES||YES|
|Specification consultant only – domestic||NO||NO|
|Reprocessor of single use devices – domestic or foreign||YES||YES|
|Remanufacturer – domestic or foreign||YES||NO|
|Foreign exporter of devices located in a foreign country - foreign||YES||NO|
|Device being investigated under Investigational Device Exemption (IDE) – domestic or foreign||NO||NO|
|Maintains complaint files - domestic or foreign||YES||YES|
|U.S. Manufacturer of export only devices - domestic||YES||YES|
* Initial distributors/importers must register their company with the FDA but Product listing is not required. Enforcement discretion used for 807.22.
Common Terms used by the FDA
Contract Manufacturer - Manufactures a finished device to another establishment's specifications.
Contract Sterilizer - Provides a sterilization service for another establishment's devices.
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 - 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.
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.
Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
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.