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Establishment Registration

• What is Establishment Registration
  
• Who Must Register
• United States Agent for Foreign Manufacturers
• When to Register
  
• How to Register
• Form FDA-2891
  
• Where to Send Registration Forms
  
• Updating Registration Data
  
• Obtaining Establishment Registration Data from CDRH
• Frequently Asked Questions
• Links

What is Establishment Registration

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. This process is known as initial establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. No registration fee is required. An establishment means any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution. The "owner/operator" of the establishment is responsible for registration. Owner/operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.

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 regulation for registration can be found in Title 21 Code of Federal Regulations, Part 807.

Who Must Register

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 (21 CFR 807.20). This includes manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, 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 no longer 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. In addition, the foreign establishments must provide FDA with the name of the United States agent representing their establishment. Foreign establishments must also continue to list the devices that they export to the U.S. on the listing form FDA-2892. The requirement for foreign manufacturers and exporters to register and identify a United States agent became effective February 11, 2002.

United States Agent for Foreign Establishments

Effective February 11, 2002, all foreign establishments must notify FDA of the name, address and phone number of their United States agent. Even if an establishment manufactures various medical devices, drugs, and/or biological products, each establishment site can designate 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.

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 510(k) Premarket Notifications (21 CFR Part 807, Subpart E)

Please note that the United States agent requirement replaces the U.S. Designated Agent (U.S.D.A.) provision in 21 CFR 807. The U.S.D.A. requirement was indefinitely stayed on July 23, 1996. In spite of being stayed, many foreign establishment notified FDA of the name of their U.S.D.A. and many U.S.D.A.'s registered. If a foreign establishment has previously notified FDA of the name of their U.S.D.A., this does NOT mean they have complied with the requirement to notify FDA of the name of their United States agent. ALL foreign establishments must notify FDA of their United States agent, even if it remains the person they previously identified as their U.S.D.A.

Until form FDA-2891(b) is available for reporting United States agent information, the foreign establishment must notify FDA of its United States agent by sending a letter to the address below. The letter must be signed by the establishment's official correspondent and should include the name of a person or business name, street address, telephone and fax numbers, and email address of the United States agent. The letter must reference the foreign establishment's name, address, official correspondent, and registration number, if the establishment is currently registered. A sample letter is available. If the establishment is registering for the first time, the registration form FDA-2891 should be mailed with the United States agent notification letter. Forms FDA-2891 or FDA-2892 cannot be used to identify a United States agent.

To assist foreign establishments in locating a United States agent, CDRH has created the United States agent database. FDA provides this database as a service. FDA does not require United States agents to be listed in this database. FDA will not review the United States agent information and has no knowledge concerning the capabilities, fees, or experience of the persons representing themselves as United States agents. FDA does not endorse the use of any of the persons whose name appears in the database.

When to Register

An owner/operator of an establishment must register themselves and each establishment they own and operate within 30 days after entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If the establishment is registering for the first time, the registration form FDA-2891 must mailed to FDA with the medical device listing form FDA-2892. Foreign establishments must register, name a United States agent, and list their devices prior to exporting to the U.S.

How to Register

To register an establishment, form FDA-2891, "Initial Registration of Medical Device Establishment" must be completed by the owner/operator or establishment and submitted to FDA.

When registering, owner/operators should note:

• Post office (P.O.) box numbers cannot be used as addresses on the form FDA-2891. FDA will not accept P.O. box numbers for establishment and owner operator addresses. The actual street address must be used.
  
  
• In the case of small businesses, the name of the owner/operator usually is the same as the name of the registering establishment.
  
  
• The official correspondent is the person designated by the owner/operator to be responsible for:
  
  
  • the annual registration of the establishment;
  • contact with FDA for establishment registration and medical device listing issues;
  • maintenance and submission of a current list of officers and directors to FDA upon request;
  • the receipt of pertinent correspondence from FDA directed to and involving the owner/operator and/or any of the firm's establishments.
 
• Establishments must register within 30 days of beginning production or prior to importing or exporting a device. Preproduction status means that the establishement has not yet begun production of its device. If preproduction status is marked "Yes," 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.
  

Form FDA-2891

Registration Form FDA - 2891
Help for completing the form can be accessed on line by double clicking on the red question mark. The definitions of operations for block 11 are reiterated below for convenience.

You should select all the codes that apply to the operations performed at this location. The listed establishment type codes are defined as follows.

CONTRACT MANUFACTURER. Manufactures a finished device to another establishment's specifications. The manufacturing establishment does not commercially distribute the device under its own name.

CONTRACT STERILIZER. Provides a sterilization service for another establishment's devices.

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.

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.

REPACKAGER AND/OR RELABELER Repackager: Packages finished devices from bulk or repackages devices made for the establishment 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.

INITIAL DISTRIBUTOR OR IMPORTER. Takes first title to devices imported into the United States.

SPECIFICATION DEVELOPER. Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing.

FOREIGN EXPORTER. Person who exports or offers for export to the United States, a device manufactured or processed by another person in a foreign country.

REPROCESSOR. Person who performs remanufacturing operations on a single use device.

Hard copies of FDA-2891 and FDA-2892 may be ordered in small quantities from CDRH:

FDA/CDRH
Publications (HFZ-220)
Division of Small Manufacturers, International and Consumer Assistance

Fax: 301-443-8818 Phone: 800-638-2041 (press 3) or 301-443-6597 (press 3)
Email: dsmica@cdrh.fda.gov

 

or

 

FDA/CDRH
Registration and Listing Branch
Office of Compliance
Phone: 301-827-4555 (press 3 then 1)
Email: reglist@cdrh.fda.gov

Where to Send Registration Forms

All copies of the completed FDA-2891 and any correspondence regarding registration, including United States agent, should be mailed to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance, HFZ-308
Registration and Listing Branch
9200 Corporate Boulevard
Rockville, MD 20850-4015

A photocopy of the form should be made and maintained for the establishment's records.

Upon receipt of the initial registration form, CDRH will send an acknowledgement letter with the owner/operator identification (ID) number assigned to the firm. The registration form is then sent to the appropriate FDA District Office for assignment of a registration number. When the registration number is assigned, CDRH will send the official correspondent a validated copy of the FDA-2891 with the registration number. Please note that the assignment of a registration number may take between 30 and 90 days. The establishment may use the owner/operator number as proof that the registration process has been completed until a registration number is assigned.

Updating Registration Data

All registration information must be verified annually and updated if changes have occurred. FDA sends the annual registration form FDA-2891(a) to all registered firms to be verified, corrected, and returned to FDA. FDA will mail the FDA-2891(a) to the owner/operator of registered establishments automatically each year on an alphabetical schedule (21 CFR 807.21). The registration year begins January 1st and ends December 31st.

Please note that when changes occur in ownership, establishment name, official corespondent, or addresses, FDA must be notified in writing at the address above within 30 days of such changes. This notification should be a letter that identifies the registered establishment's registration and owner/operator ID numbers with a description of the changes noted above. The letter must be signed by the establishment's official correspondent.

Obtaining Establishment Registration Data from CDRH

CDRH Freedom of Information (FOI) releasable establishment registration information is available directly from the Internet without having to submit an FOI request.

• Releasable Establishment Registration Information
• Registration Database

Frequently Asked Questions

How do I know if my registration is current?

Check the registration database on the Internet at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/registration.cfm

I did not receive my annual registration form FDA-2891(a). How do I update my establishment’s registration?

FDA sends form FDA-2891(a) to registered establishments every year to update registration information. If you have lost the form, a new one will not be sent. In order to update your registration, send a letter to the address noted above stating that you would like to update and receive credit for your annual registration. Please note the establishment’s registration number on the letter. The letter must be signed by the official correspondent.

I sent in the establishment registration FDA-2891 two months ago and I still have not received a reply.

Check your copy of the form FDA-2891 that you completed. If you checked Preproduction Status, your registration will not be processed until you notify FDA that you are ready to begin production. To notify FDA that you are ready to begin production, send a letter to the address noted above stating that you have begun production or will begin production within 30 days. If you have not checked this box, please call the Division of Small Manufacturers, Consumer and International Assistance at 800-638-2041 or 301-443-6597 for assistance.

My form FDA-2891 has an expiration date of December 31, 2001. Can I still use this form?

No. You must a form with a March 31, 2005 expiration date.

How much does registration cost?

There is no fee for registration.

Are foreign dental and optical laboratories required to register and list?

Yes, foreign dental and optical laboratories are not exempt from registration and listing. The exemption in 21 CFR 807.65(i) only applies to domestic establishments.

My facility only does design work. Am I required to register the facility?

Company owned design facilities must register. That is, if a manufacturer owns a manufacturing facility and a separate facility for design work, both must register. Third party design facilities are not required to register. The manufacturer that contracts out the design work is responsible for maintaining the design control documentation in accordance with 21 CFR 820.30.

I am a distributor located outside the U.S. Do I have to register?

Yes, foreign exporters must register the facility, list the devices exported to the U.S., and have a United States agent.

If I change the address of my establishment or if the owner/operator of the establishment changes, do I have to update the devices listings?

No, only the registration needs to be updated by submitting a 2891(a) form or a letter signed by the official correspondent. The changes are automatically applied to any existing listings for that owner/operator and establishment registration. You do not have to individually update the listings unless you are deleting them.

Is a U.S. Designated Agent the same as a United States agent?

No. The United States agent requirement replaces the U.S. Designated Agent (U.S.D.A.) provision in 21 CFR 807. The U.S.D.A. requirement was indefinitely stayed (placed on hold) on July 23, 1996 and has now been deleted from the regulation. The United States agent is a new requirement and different from the U.S. D.A requirement. Form FDA-2891 cannot be used to name a United States agent. A letter must be submitted to FDA with United States agent information until form FDA-2891(b) is available.

In spite of being stayed, many foreign establishment notified FDA of the name of their U.S.D.A. and many U.S.D.A.'s registered. If a foreign establishment has previously notified FDA of the name of their U.S.D.A., this does NOT mean they have complied with the requirement to notify FDA of the name of their United States agent. ALL foreign establishments must notify FDA of who their United States agent is, even if it remains the person they previously identified as their U.S.D.A.

Links

Additional registration information

Updated 12/9/2003

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