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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 establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met.
ESTABLISHMENT
Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution.OWNER/OPERATOR
The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment.
Registration of an establishment is not an approval of the establishment or its products by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance or approval is required before a device can be placed into commercial distribution in the U.S.
Misbranding by Reference to Establishment Registration Number: Title 21 of the Code of Federal Regulations, Section 807.39, states, "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding." Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.
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. This includes manufacturers, contract manufacturers and contract
sterilizers that place the device into commercial distribution, 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 ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly
to the end user.)
Initial Distributor
An initial distributor (or importer) takes first title to the devices
imported into the U.S. and further distributes the devices. Initial distributors/importers
are required to register. However, they are NOT required to list the devices
that they import.
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. This includes contract manufacturers
and contract sterilizers. Foreign establishments must also list the devices
that they export to the U.S.
Definitions of establishment activities are provided below. Prior to registering your establishment, please review the definitions and determine what type of activities your establishment is performing. Please note that most establishments are also required to list their devices.
Please review the registration and listing chart under Who Must Register and List for further guidance.
Please note that the following groups are not required to register:
The following types of establishments are required to pay the establishment registration fee:
Initial distributors are not required to pay the fee.
The establishment registration fee for fiscal year 2008 is $1706.
To make payment, follow the instructions on the FURLS screen. Be sure to allow for enough time for your payment to be received and recorded. This process can take up to two weeks. Your registration is not complete until FDA has been notified that all requirements have been met.
All foreign establishments must notify FDA of the name, business name, address, phone number, 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)
How to Notify FDA of U.S. Agent
The official correspondent of a foreign establishment will identify the United States Agent at the time of electronic submission of establishment registration information. The official correspondent may also electronically update the United States Agent information at any time.
Domestic establishments must register within 30 days of the establishment entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration.
Foreign establishments must register, notify us of their United States agent, as well as list their devices prior to exporting to the U.S.
You must renew your registration annually between October 1st through December 31st of each year. The registration period extends from October 1st through September 30th.
On September XX, 2007, Section 207 of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) amended section 510 of the Federal Food, Drug and Cosmetic Act (the Act) to require electronic submission of device registration and listing information unless FDA grants a waiver request. MDUFMA also authorizes FDA to collect a user fee for annual registration of certain types of establishments. Effective October 1, 2007, all establishment registrations are to be submitted electronically using FDA’s Unified Registration and Listing System (FURLS), unless a waiver has been granted by FDA.
Complete the registration process through the FURLS accessed through the Registration and Device Listing website. You are required to have an account ID and password in FURLS in order to submit your registration.
You will also be asked to provide an email address. We recommend that you provide the email address that can be accessed by your designated official correspondent. The Official Correspondent is the person designated by the owner/operator to be responsible for:
You may also need to create sub-accounts for the official correspondent for each registered establishment.
Please note:
All registration information must be verified annually between October 1st and December 31st of each year using FURLS accessed through the Registration and Device Listing website. When completing your annual establishment registration requirement, you will have the opportunity to review the registration and listing information that FDA has on file for you and to update the information if any changes have occurred.
You can access FURLS at any time to update any changes that may occur throughout the year.
Establishments must pay their establishment registration fee by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th).
The law requires that all registration and listings be submitted electronically unless FDA grants you a waiver “because electronic registration and listing is not reasonable for the person requesting such waiver”. To apply for a waiver, please submit your request with a complete explanation of why you cannot submit your registration and listing through the Internet to:
Food and Drug Administration
Center for Devices and Radiological Health
HFZ-308
9200 Corporate Boulevard
Rockville, MD 20850-4015
The establishment activities are defined as follows. You should only select the establishment types that apply to the operations being performed at the establishment you are registering.
CONTRACT MANUFACTURER
Manufactures a finished device to another establishment's specifications and places the device into commercial distribution. (Please note that contract manufacturers are also required to list their devices).CONTRACT STERILIZER
Provides a sterilization service for another establishment's devices and places the device into commercial distribution. (Please note that contract sterilizers are also required to list the devices sterilized at their establishment).FOREIGN EXPORTER
Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.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
Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance, safety, specifications, or in any way changes the 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/ IMPORTER
Takes first title to devices imported into the United States. An initial distributor must have a U.S. address.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.REPROCESSOR OF SINGLE-USE DEVICES
Performs remanufacturing operations on a single-use device.U.S. MANUFACTURER OF EXPORT ONLY DEVICES
Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.
Releasable establishment registration information under the Freedom of Information Act is available directly from the Internet. The database is updated monthly.
How much does registration cost?
The registration fee for fiscal year 2008 is $1,706.
How can I find out if my registration number has been assigned?
Once you submit your establishment registration information, you will receive an email notifying you of your registration number in approximately 30-90 days. Until your registration number is assigned, please reference your Owner Operator number in any correspondence with FDA. If you have not received an email and wish to find out if your registration number has been assigned:
- You can send an email to device.reg@fda.hhs.gov. .
- You can contact the Registration and Listing Office at 240-276-0111.
- You can search the CDRH Establishment Registration. The database is updated on or about the 5th of each month.
How long is my registration valid?
Each establishment registration is valid for one fiscal year (October 1st through September 30th). Firms must complete their annual registration establishment requirement between October 1st and December 31st of each year for the registration to be valid.
How do I know if my registration is current?
You may access your FURLS account at any time to determine your registration status. You can also check your registration record on the CDRH Establishment Registration database. You can determine if your registration is current by looking at the "Date of Registration Status" field that appears on your establishment registration record.
Why hasn't my registration been updated on the Internet?
The CDRH registration and listing Internet databases are updated on or about the 5th day of every month. Changes to registration and listing that you submit electronically will be available for your review when you log into your FURLS account. However, they will not appear on the public Internet databases until after the 5th of the month following the change.
If I change the address of my establishment or if the owner/operator of the establishment changes, do I have to update the device listings?
If you change the address of your establishment, you do not need to update your device listings. If your establishment is sold to another owner/operator, you will maintain the same registration number and you will need to create new listings for those products that will continue to be produced at the establishment.
How does FDA determine which registration number is kept when an establishment merges with another registered establishment?
Generally, when one establishment merges with another, we will consult with the registration monitor in the applicable FDA District Office (domestic establishments) or with FDA's Division of Field Investigations (foreign establishments) to determine which registration number should be maintained. We typically use the oldest number as it has more historical information associated with it.
Is there an FDA policy for when multiple registration numbers are issued to establishments at the same street address?
There are situations where the same street address will be issued multiple registration numbers. One example is an office park where there are many buildings at the same street address. Each building may have a different registration number. Another example would be where different legal entities share the same space, but are not under the same management control. If a firm rents some of the space, they would have a different registration number. If they have the same owner and management, FDA wouldn't issue a second registration number.
Does registration or device listing fulfill my Premarket Notification 510(k) requirements?
No. The establishment registration and device listing requirement is a separate requirement from the Premarket Notification 510(k) submission process. See Device Advice for information on how FDA regulates devices including how to submit a 510(k).
I am a distributor located outside the U.S. Do I have to register?
Yes, foreign exporters must register their establishment, list the devices exported to the U.S., and identify a United States agent..
Are foreign dental and optical laboratories required to register and list?
Yes, foreign dental and optical laboratories are required to register and list. They are not exempt from registration and listing. The exemption in 21 CFR 807.65(i) only applies to domestic establishments.
My establishment only does design work. Am I required to register the establishment?
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 (design contractors) 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.
Updated March 3, 2008
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