Medical Devices
Who Must Register, List and Pay the Fee
Frequently Asked Questions about the New Device Registration and Listing Requirements
Please contact reglist@cdrh.fda.gov for further information.
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
Activity | Register | List | Pay Fee |
Manufacturer | YES 807.20(a) | YES 807.20(a) | YES |
Manufactures a custom device | YES 807.20(a)(2) | YES 807.20(a)(2) | YES |
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user | YES 807.20(a)(5) | YES 807.20(a)(5) | YES |
Manufacturer of components that are distributed only to a finished device manufacturer | NO 807.65(a) | NO | NO |
U.S. Manufacturer of export only devices | 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 |
Contract manufacturer who commercially distributes the device for the specifications developer | YES 807.20(a)(2), | YES 807.20(a)(2), | YES |
Contract manufacturer who does NOT commercially distribute the device for the specifications developer | NO | NO | NO |
Contract manufacturer of subassembly or component, Contract Packager or Labeler | NO | NO | NO |
Contract sterilizer who commercially distributes the device | YES 807.20(a)(2), | YES 807.20(a)(2), | YES |
Contract sterilizer who does NOT commercially distribute the device | NO | NO | NO |
Kit Assembler | YES 807.20(a) | YES 807.20(a) | YES |
Domestic Distributor | NO 807.20(c)(3) | NO | NO |
Specification Developer | YES 807.20(a)(1) | YES 807.20(a)(1) | YES |
Specification Consultant Only | NO | NO | NO |
Initial Distributor/Importer | YES 807.40(a) | NO Enforcement Discretion Used for 807.22(c) | NO |
Device being investigated under IDE | NO | NO 807.40(c) | NO |
Reprocessor of single use devices | YES 807.20 | YES 807.20 | YES |
Remanufacturer | YES | YES | NO |
Maintains complaint 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 |
Foreign 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. | YES 807.40(a) | YES 807.40(a) | YES |
Contract Sterilizer whose sterilized device is shipped to U.S. by the sterilizer. | 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 complaint 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.
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.