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 In this section:

                Device Registration and Listing

Device Registration and Listing

                        Important Reminders about Registration and Listing
          Access Electronic Registration
          Who Must Register, List and Pay the Fee
          When to Register and List
          How to Register and List
          Payment Process
          U.S. Agents
          FDA Onsite Registration and Listing Verifications
          Frequently Asked Questions about the New Device Registration and Listing Requirements
          Search Registration and Listing Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
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          Device Registration and Listing
          Who Must Register, List and Pay the FeeDevice Registration and Listing Who Must Register, List and Pay the Fee
  
  	
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    PrintEstablishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (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 (Title 21 CFR Part 807).

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
	Foreign establishments
	Definitions of establishment types**Domestic establishments**

Activity
			Register
			List
			Pay FeeContract 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 FeeContract 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.

Additional Resources

Other FDA Establishment Registration Sites

                                                                                  Content current as of:
      09/27/2018
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsDevice Registration and Listing

          
                        Important Reminders about Registration and Listing
          Access Electronic Registration
          Who Must Register, List and Pay the Fee
          When to Register and List
          How to Register and List
          Payment Process
          U.S. Agents
          FDA Onsite Registration and Listing Verifications
          Frequently Asked Questions about the New Device Registration and Listing Requirements
          Search Registration and Listing
 
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