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Note: Unless you are familiar with Establishment Registration, it is essential to review that requirement before proceeding with Medical Device Listing.
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. The regulations for medical device listing are provided in 21 CFR 807.
Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).
Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.
All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.
While there is no separate fee for listing your device, device listing is completed as part of the annual registration process. Many device establishment types are subject to an annual registration fee.
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 with FDA 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 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.) (21 CFR 807.20). Foreign manufacturers and foreign exporters must list their devices prior to importing into the U.S.
Contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the device. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.
An establishment is required to list their device(s) if they are performing one or more of the following activities:
CONTRACT MANUFACTURER
Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.CONTRACT STERILIZER
Provides a sterilization service for another establishment's devices and places the device into commercial distribution.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 or 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.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.
Please note:
Please review the registration and listing chart under Who Must Register and List for further guidance.
When an owner/operator of a domestic establishment enters into an activity that requires registration, device listing much be completed at the time of registration for the establishments that are required to list as discussed above under "Who Must List." The owner/operator must also submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed.
Foreign establishments must to submit device listings prior to exporting their devices to the United States.
Registered establishments are also required to review and update their listing information once per year, during the registration period of October 1st to December 31st of each year.
You can update your device listing(s) at any time. We encourage you to update your device listings at time the change occurs.
All listing information (new, updates or annual review) must be submitted electronically unless FDA grants you a waiver. Electronic registration and listing is completed through FDA’s United Registration and Listing System (FURLS).
If you are performing your annual registration and listing renewal:
If your product requires 510(k) clearance or PMA approval, you will:
If your product is 510(k) exempt, you will:
FURLS will assist you in finding the appropriate product code for your 510(k) exempt device by using the device name You may also use the Product Classification Database to find the appropriate product code prior to logging on to FURLS. The Guidelines for Selecting a Product Code for Medical Device Listing provides instructions to assist you with selecting a product code.
A device listing number will be created for new listings.
If you are submitting listing information at times other then your annual listing requirement, you will:
Provide the following information:
FURLS will assist you in finding the appropriate product code for your 510(k) exempt device using the device name You may also use the Product Classification Database to find the appropriate product code prior to logging on to FURLS. The Guidelines for Selecting a Product Code for Medical Device Listing provides instructions to assist you with selecting a product code.
If you cannot determine the appropriate product code dor exempt device using the Product Classification Database, contact the Division of Small Manufacturers, Consumer and International Assistance (DSMICA): phone 800-638-2041 or 240-276-3150; email dsmica@cdrh.fda.gov; or fax 240-276-3151 for assistance.
For 510(k) exempt devices, you can only complete one listing entry for each device type (device name or product code). For example, you will list one time using the product code, LRW, for various sizes of surgical scissors. You may add several proprietary or trade names.
A device listing number will be created for new listings.
The official correspondent of each establishment is responsible for keeping their listing records current. You can update your device listing(s) at any time through FURLS.
The owner/operator must submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed. We encourage you to update your device listings at time the change occurs.
Updating is required when one of the following occurs:
You are encouraged to identify proprietary names or trade names to distinguish various models of the same device.
Releasable medical device listing information under the Freedom of Information Act is available directly from the Internet. The database is updated monthly.
How much does device listing cost?
There is no fee for device listing. However, many estabishments are subject to a registration fee. You must submit device listing information at the same time as the annual establishment registration requirement, October 1 to December 31 of each year.
Does the initial distributor/importer have to list the devices that they are importing into the United States?
No, initial distributors/importers do not list the devices that they import into the United States. The foreign manufacturer is responsible for listing the devices.
How do I know which devices I have already listed?
Your device listing information, including the listing number, is available by logging into FURLS. The device listing will begin with the letter A, B, C, E, Q, R, or D.
You may also search the device listing database on the Internet. You may search by owner/operator name, owner/operator number, or establishment registration number to find the devices that you have listed.
When will I receive my device listing number?
Your device listing number will be available online as soon as your establishment is registered and you have entered your listing information into FURLS.
I have a device listing for my product. The device has not changed. However, my company would now like to change the brand name of the product. How do I update my device listing for this change?
You may log on to the FURLS system at any time and update your listings. You may change the brand name of any product or add multiple brand/proprietary names for a listing.
I import brand new medical devices that were originally made in the United States, back to the United States. Do I have to list? Do I have any other regulatory requirements that I have to comply with before importing these devices back to the United States?
The FDA refers to these devices as "American Goods Returned." Many times, U.S. medical device manufacturers make devices that are not intended for sale in the United States. Although you do not have to list, you are required to register as an initial distributor/importer. The foreign exporter is required to register, list, and identify their United States agent.
When importing "American Goods Returned," you must be able to prove the products you are importing are in compliance with applicable premarket regulations and saleable in the United States. The labeling must have the correct indications for use. Devices must have received appropriate clearances and approval and comply with the Quality Systems Regulation Good Manufacturing Practices. See Surveillance of American Goods Returned.
Additional device listing information
Establishment Registration
Updated October 17, 2007
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