Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, 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 tabel offers the detail of 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.
- Domestic establishments
- Foreign establishments
- Definitions of establishment types
Domestic establishments
|
Activity
|
Register
|
List
|
Pay Fee
|
|
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
|
|
Device being investigated under IDE
|
NO
|
NO
807.40(c)
|
NO
|
|
Domestic Distributor that does not import devices
|
NO
807.20(c)(3)
|
NO
|
NO
|
| |
|
|
|
|
Any establishment located in a foreign trade zone involved with the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for commercial distribution in the United States
|
YES
|
YES
|
YES
|
|
Import agent, broker, and other parties who do not take first possession of a device imported into the United States
|
NO
|
NO
|
NO
|
|
Initial Importer
|
YES
807.40(a)
|
NO
Identify manufacturers
per 807.20(a)(5)
|
YES
|
|
Maintains complaint files as required under 21 CFR 820.198
|
YES
|
YES
|
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 not otherwise classified as a finished device, that are distributed only to a finished device manufacturer
|
NO
807.65(a)
|
NO
|
NO
|
|
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
|
|
Refurbishers or remarketers of used devices already in commercial distribution in the United States.
|
NO
|
NO
|
NO
|
|
Relabeler or Repackager
|
YES
807.20(a)(3)
|
YES
807.20(a)(3)
|
YES
|
|
Remanufacturer
|
YES
|
YES
|
YES
|
|
Reprocessor of single use devices
|
YES
807.20
|
YES
807.20
|
YES
|
|
Specification Consultant Only
|
NO
|
NO
|
NO
|
|
Specification Developer
|
YES
807.20(a)(1)
|
YES
807.20(a)(1)
|
YES
|
|
U.S. Manufacturer of export only devices
|
YES
807.20(a)(2)
|
YES
807.20(a)(2)
|
YES
|
|
Wholesale distributor that is not a manufacturer or importer
|
NO
|
NO
|
NO
|
Foreign Establishments
|
Activity
|
Register
|
List
|
Pay Fee
|
|
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
|
|
Custom Device Manufacturers
|
YES
807.20(a)(2)
|
YES
807.20(a)(2)
|
YES
|
|
Device Being Investigated under IDE
|
NO
812.1 (a)
|
NO
812.1(a),
807.40(c)
|
NO
|
|
Foreign Exporter of devices located in a foreign country
|
YES
807.40 (a)
|
YES
807.40 (a)
|
YES
|
|
Foreign Manufacturers
(including Kit Assemblers)
|
YES
807.40(a)
|
YES
807.40(a)
|
YES
|
|
Maintains complaint files as required under 21 CFR 820.198
|
YES
|
YES
|
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
|
|
Relabeler or Repackager
|
YES
807.20(a)(3)
|
YES
807.20(a)(3)
|
YES
|
|
Remanufacturer
|
YES
|
YES
|
YES
|
|
Reprocessor of Single-use Device
|
YES
807.20(a)
|
YES
807.20(a)
|
YES
|
|
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, 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 - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
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.
Source: www.fda.gov |
