Establishment Registration

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.  This process is known as establishment registration (Title 21 CFR Part 807).

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE).

Congress has authorized FDA to collect an annual establishment registration fee for device establishments. The establishment registration fee is not eligible for a reduced small business fee.

Need help filing your establishment registration?  The Office of Robert P. Mino, PA, can help.

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

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: FDA.gov

(Note: Subject to change at any time, you should consult an attorney for current updates to the law.  This page is offered for informational purposes only and should not be relied upon for any legal advice or information.)