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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Medical Device Listing

• What Is Medical Device Listing
  
• Who Must List
  
• When To List
• How To List
• Forms
  
• Where To Send Listing Forms
  
• Updating Listing Data
  
• Obtaining Medical Device Listing Data from CDRH
• Frequently Asked Questions
  

What Is Medical Device Listing

Most medical device establishments required to register with FDA must list 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 marketing. 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. No listing fee is required.

Who Must List

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, 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. Although contract manufacturers, contract sterilizers and initial importers located in the U.S. are required to register their establishments, these establishments are not required to list devices on form FDA-2892.

When To List

An owner/operator of an establishment located in the U.S. that is required to list should do so within 30 days of beginning a manufacturing operation as discussed above under "Who Must List." An establishment located outside of the U.S. must list the device prior to exporting to the U.S. Please note that if an establishment is registering for the first time, both the Establishment Registration (FDA-2891) and Medical Device Listing (FDA-2892) must be submitted together. A foreign establishment also needs to submit a United States agent notification letter.

How To List

Listing of a medical device is done by completing form FDA-2892, Medical Device Listing. FDA has developed a Product Classification Database to identify the generic category, that is, classification or device name, which is placed on form FDA-2892.

When listing, please note:

• The Product Classification Database contains classification/device names and classification numbers (product codes) to be entered on form FDA-2892. The classification name and product code identify the generic category of device for FDA. Please note that the product code (three letter code) is entered on the form, not the regulation number (21 CFR 862-892).
  
  
• Only one form FDA-2892 is required for each generic category (classification/device name/product code) of device. Therefore, for various sizes of syringes that fall within the same three letter product code, fill out only one form FDA-2892 for all of your establishments (or manufacturing sites) that manufacture this type of device.
  
  
• If the device also requires a Premarket Notification 510(k) or Premarket Approval, the product code on the form FDA-2892 should be the same as that provided on the FDA clearance or approval letter unless a new product code has been created that better represents the generic device category.
  
  
• Keep the yellow copy of the form FDA-2892 because, unlike registration, CDRH does not acknowledge receipt or return a validated copy of the form FDA-2892. The yellow copy of the FDA-2892 that is retained is proof of listing. The unique listing number can be found in the "Document Number" block of the form and begins with the letter A, B, C, E, Q, or R.

Forms

• Device Listing Form FDA-2892
  Help for completing the form can be accessed on line by double clicking on the red question mark.
  
  
• Product Classification Database

If you cannot locate the appropriate product code from the Product Classification Database, you may contact the Division of Small Manufacturers, Consumer and International Assistance (DSMICA): phone 800-638-2041 or 301-443-6597; email dsmica@cdrh.fda.gov; fax 301-443-8818.

Obtaining Hard Copies of Forms

Forms FDA-2891 and 2892 may be ordered in small quantities from 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

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

Where To Send Listing Forms

The completed listing forms should be mailed to:

Updating Listing Data

Unlike registration, FDA does not send out an annual update for device listing. Owner/operators and foreign establishments are responsible for keeping data on their listing forms current. Updating is accomplished through the submission of another FDA-2892 at the time the change occurs, or twice a year during June or December. Updating is required when one of the following occurs:

• A "new" device is marketed with a classification name (three letter product code) that is not currently listed. That is, establishments should list once per product code.;
  
  
• The intended use of a listed device changes in such a way that would result in its being more appropriately classified under a different generic category (classification name);
  
  
• The marketing of all models or variations of the listed device is discontinued;
  
  
• A discontinued device type, that is not listed, is re-marketed; or
  
  
• Any information that was supplied on the form FDA-2892 has changed, other than changes in proprietary and common or usual name, and changes in owner/operator information. Owner/operator changes are reported by updating the establishment’s registration information. Changes in trade or brand name of the device should not be submitted.

Obtaining Medical Device Listing Data from CDRH

CDRH Freedom of Information (FOI) releasable medical device listing information is now available directly from the Internet without having to submit an FOI request.

• Releasable Medical Device Listing Information
• Listing Database

Frequently Asked Questions

My form FDA-2892 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 device listing cost?

There is no fee for device listing.

I have only one copy of device listing form FDA-2892. Can I photocopy this form?

No. Each form has a unique device listing number on the form. Only original forms can be used.

I submitted a device listing form FDA-2892. How can I get my device listing number?

The device listing number is entered in the "Document Number" block of the form that you submitted. It will begin with the letter A, B, C, E, Q, or R.

I am not sure if I listed my device. How can I determine if I did?

Search the device listing database on the Internet at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm. You may search by owner/operator name, owner/operator number, or establishment registration number to find the devices that you have listed.

Should I wait to receive a registration number before I list?

No, you MUST send the registration form FDA-2891 and the device listing form FDA-2892 together if you are registering for the first time. If a manufacturer submits FDA-2891 without the FDA-2892, it will be returned without processing.

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?

Do not update your device listing information for a change to the brand or trade name of the product. See "Updating Listing Data" above for when updating is required

I am an importer, can I submit the listing form FDA-2892 for the foreign establishment?

No, the foreign manufacturer must submit the form signed by the foreign establishment’s official correspondent.

Updated 11/19/2003

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