Medical Devices
Who Must Register, List and Pay the Fee
|
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment. The following charts detail the requirements for registration and listing based on the type of activity performed at that establishment. The chart also includes a column showing which types of activities require payment of the establishment registration fee. See the Fee page for additional details. Domestic establishments
|
|
Register |
List |
Pay Fee |
|
| Foreign Manufacturers | YES 807.40(a) |
YES 807.40(a) |
YES |
| Foreign Exporter of devices located in a foreign country | YES 807.40 (a) |
YES 807.40 (a) |
NO |
| Contract Manufacturer whose device is shipped to U.S. by the contract manufacturer or by any other firm | YES 807.40(a) |
YES 807.40(a) |
YES |
| Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer or by any other firm. | YES 807.40(a) |
YES 807.40(a) |
YES |
| Reprocessor of Single-use Device | YES 807.20(a) |
YES 807.20(a) |
YES |
| Custom Device Manufacturers | YES 807.20(a)(2) |
YES 807.20(a)(2) |
YES |
| Relabeler or Repackager | YES 807.20(a)(3) |
YES 807.20(a)(3) |
NO |
| Kit Assembler | YES 807.20(a) |
YES 807.20(a) |
YES |
| Device Being Investigated under IDE | NO 812.1 (a) |
NO 812.1(a), 807.40(c) |
NO |
| Specification Developer | YES | YES | YES |
| Remanufacturer | YES | YES | NO |
| Manufacturer of components that are distributed only to a finished device manufacturer | NO 807.65(a) |
NO | NO |
| Maintains compliant files as required under 21 CFR 820.198 (Note: register as a manufacturer if physical manufacturing taking place at site, otherwise register as a specification developer) |
YES | YES | YES |
Definitions of Establishment Activities
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.
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.