This section covers how to Establish Registration/Device Listing/U.S. Agent Representation
- When to Register
- How to Register
- Where to Send Registration Forms
- Device Listing
- United States Agent for Foreign Establishments
Establishment Registration (FDA Form 2891)
Companies that have never distributed finished medical devices to the United States or its territories must be first registered with the Food and Drug Administration.
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 (see next section, Device Listing). Foreign establishments that do not have a physical presence in the U.S. must register, name a United States agent, and list their devices (using Form 2892) 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 establishment 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.
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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.
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Medical Device Listing (FDA Form 2892)
Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing.
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 list its device on form FDA 2892 within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components sold directly to the end user ( 21 CFR 807.20). Foreign manufacturers must list their devices prior to importing into the U.S.
Domestic contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the devices. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.
Listing of a medical device is done by completing form FDA 2892, Device Listing.
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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)
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.
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.
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- When to Register
- How to Register
- Where to Send Registration Forms
- Device Listing
- United States Agent for Foreign Establishments
