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U.S. Department of Health and Human Services

Medical Devices

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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 Payment Process page for additional details.

Domestic establishments

ActivityRegisterListPay Fee
Manufacturer
(including Kit Assemblers)
YES
807.20(a)
YES
807.20(a)
YES
Manufactures a custom deviceYES
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 userYES
807.20(a)(5)
 
YES
807.20(a)(5)
YES
Manufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)
NONO
U.S. Manufacturer of export only devicesYES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or RepackagerYES
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 sterilizerYES
807.20(a)(2),
 
YES
807.20(a)(2),
 
YES
Domestic DistributorNO
807.20(c)(3)
NO NO
Specification DeveloperYES
807.20(a)(1)
 
YES
807.20(a)(1)
YES
Specification Consultant OnlyNO
 
NONO
Initial ImporterYES
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
 
NONONO
Device being investigated under IDENONO
807.40(c)
NO
Reprocessor of single use devicesYES
807.20
YES
807.20
YES
RemanufacturerYESYESYES
Maintains complaint files as required under 21 CFR 820.198YESYESYES
Establishments located in foreign trade zoneYESYESYES
RefurbishersNONONO

Foreign Establishments

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 countryYES
807.40 (a)
YES
807.40 (a)
YES
Contract Manufacturer
(including contract packagers)
YES
807.40(a)
YES
807.40(a)
YES
Contract SterilizerYES
807.40(a)
YES
807.40(a)
YES
Reprocessor of Single-use DeviceYES
807.20(a)
YES
807.20(a)
YES
Custom Device ManufacturersYES
807.20(a)(2)
YES
807.20(a)(2)
YES
Relabeler or RepackagerYES
807.20(a)(3)
YES
807.20(a)(3)
YES
Device Being Investigated under IDENO
812.1 (a)
NO
812.1(a),
807.40(c)
NO
Specification Developer YESYESYES
RemanufacturerYESYESYES
Manufacturer of components that are distributed only to a finished device manufacturerNO
807.65(a)
NONO
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end userYES
807.20(a)(5)
YES
807.20(a)(5)
YES
Maintains complaint files as required under 21 CFR 820.198YESYESYES


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.