All establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. The regulations for establishment registration are provided in 21 CFR 807.

Registration of an establishment is not an approval of the establishment or its devices by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance is required before a device can be placed into commercial distribution in the U.S.

The Act

Section 510 of the Food, Drug and Cosmetic Act - Registration of Producers of Drugs and Devices.

The Regulations

PART 807

ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

Manufacturers
An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register on form FDA 2891, Registration of Device Establishment, (21 CFR 807.20). This includes manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are sold or leased directly to the end user.

Initial Importers
An initial importer (or initial distributor) takes first title to the devices imported into the U.S. and further distributes the product. Initial importers are required to register. However, they are NOT required to list the products that they import on form FDA 2892.

Wholesale distributors of devices, who do not manufacture, repackage, process, or relabel a device, are not required to register their establishment with the FDA. A "wholesale distributor" is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

Foreign establishments (manufacturers and exporters)
Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments on form FDA 2891. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S. on the listing form FDA 2892.

In addition, foreign establishments must provide FDA with the name, address, phone and fax numbers, and email address of the United States agent representing their establishment. The requirement for foreign manufacturers and exporters to register and identify a United States agent became effective February 11, 2002.

Definitions of establishment types are provided here. Please note that most establishments are also required to list their devices on form FDA 2892, Device Listing.

Please review the registration and listing chart under Who Must Register and List for further guidance.

Effective February 11, 2002, all foreign establishments must notify FDA of the name, address, phone and fax numbers, and email address of their United States agent. Even if an establishment manufactures various medical devices, drugs, and/or biological products, each establishment can identify only one United States agent. The United States agent must either reside in the U.S. or maintain a place of business in the U.S. The United States agent cannot use a post office box as an address. The United States agent cannot use an answering service. The agent must be available to answer the phone or have an employee available to answer the phone during normal business hours. The Official Correspondent for registration may also be the United States agent for the establishment, but this is not required.

Responsibilities of United States Agent

The responsibilities of the United States agent are limited. They include:

• assisting FDA in communications with the foreign establishment,
• responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
• assisting FDA in scheduling inspections of the foreign establishment.

In addition, if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered equivalent to providing the same information or documents to the foreign establishment. The United States agent has no responsibility to report adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or to submit Premarket Notifications [510(k)] (21 CFR Part 807, Subpart E)

To register an establishment, form FDA 2891, "Registration of Device Establishment" must be completed by the official correspondent designated on the form and submitted to FDA. The form must contain the original signature of the official correspondent identified on form FDA 2891

If you are registering for the first time and you are also required to list your devices, you must submit the forms FDA 2891 and FDA 2892 together.

• Establishments must register within 30 days after entering into any activity requiring registration or prior to importing or exporting a device.

• Preproduction status means that the establishment has not yet begun production of its device. If you select item 4.3 Preproduction as the type of registration, FDA will not process the form or assign a registration number until the establishment sends a letter to FDA at the address below stating that the establishment will begin production within 30 days. You are not required to submit a preproduction registration; you may simply send in a completed "in production" form within 30 days after entering into any activity requiring registration.

Go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/printforms.cfm and select Complete Form for forms FDA 2891 and 2892. Read the instructions, complete the form online and then print the completed form.