Who Must Register, List and Pay the Fee
Foreign Establishments美国公司
Activity | Register | List | Pay Fee |
Foreign Manufacturers (including Kit Assemblers) | YES 807.40(a) | YES 807.40(a) | YES |
Foreign Exporter of devices located in a foreign country | gmail免费邮箱注册YES 807.40 (a) | YES 807.40 (a) | YES |
Contract Manufacturer (including contract packagers) | YES 807.40(a) | YES 807.40(a) | YES |
Contract 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) | 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 | YES |
Manufacturer of components that are distributed only to a finished device manufacturer | NO 807.65(a) | NO | NO |
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 |
Maintains complaint files as required under 21 CFR 820.198 | YES | YES | YES |
Domestic establishments 美国境内公司
Activity | Register | List | Pay Fee |
Manufacturer (including Kit Assemblers) | 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)(6) | YES 807.20(a)(6) | 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) | YES |
Contract manufacturer (including contract packagers) | YES 807.20(a)(2), | YES 807.20(a)(2), | YES |
Contract sterilizer | YES 807.20(a)(2), | YES 807.20(a)(2), | 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 Importer | YES 807.40(a) | NO Identify manufacturers per 807.20(a)(5) | YES |
Import agent, broker, and other parties who do not take first possession of a device imported into the United States | NO | NO | 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 | YES |
Maintains complaint files as required under 21 CFR 820.198 | YES | YES | YES |
Establishments located in foreign trade zone | YES | YES | YES |
Refurbishers | NO | NO | NO |
FDA公司类型定义：
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, prepared, propagated, compounded, or processed 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 Importer - Takes first title to devices imported into the U.S. An Initial Importer 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 Device - 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.
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