The most important thing to remember about the Medical Device Listing regulation is that it has nothing to do with FDA approval of a device or an establishment!

It is in reality a relatively simple form to fill out.  It is called Form-2892.  Foreign manufacturers must list their devices prior to importing into the U.S.  There is no listing fee. There are instructions and forms available from the FDA.  Visit.  Often, foreign manufacturers ask consultants in the U.S. to act as their “official correspondent” to take care of maintaining current manufacturer registrations and listings. Some U.S. agents also act as official correspondents. (See Archives)

Unless your firm meets the relatively narrow exemptions listed in 21 Code of Federal Regulations (CFR) Sec. 807.65 and you are engaged in the manufacture, preparation, propagation, compounding, and assembly or processing of a medical device, you are required to list your devices that are produced for commercial distribution in the U.S. prior to importing into the U.S. This includes manufacturers, repackagers, relabelers, specification developers, reprocessors of single-use devices, remanufacturers, and manufacturers of accessories and components sold directly to the end user. Contract manufacturers, contract sterilizers and initial importers are not required to list devices on form FDA-2892.

So, what is device listing?  It is a form designed to tell the FDA the generic category of the device you are marketing.  The information is used by the FDA in conducting inspections and it ensures the FDA knows what classes of products are coming into the U.S. from foreign countries. There is a separate regulation number for most types of devices.  They can be found in Parts 862-892 of Title 21 of the Code of Federal Regulations (CFR). Each regulation for a medical device has a “Classification Name” as its title.  The Classification Name is often different from the “Device Name”. 

What you are looking for is the three letter product code for your device. (The term “Product Code” is also called by the FDA, much to everyone’s confusion, as the “Classification Number”).  If your Premarket Notification (510(k)) has been cleared, the product code will be included in the FDA clearance letter.  You will not find the product code in the regulation.  This is because a single classification name may cover a number of devices, some of which have different product codes.

The easiest way to find the Product Code is to go to: Link

If you know the regulation number or Device Name, Classification Name or common name, you should be able to find the Product Code.  Sometimes, it is not so easy to select the code closest to your device. You need to read the descriptions carefully. Look up the Device Name “Pin, fixation, threaded”. You will find that the product code is JDW. 

Product Classification Database

Click on the Regulation Number and you will see that there are a number of different types of fixation fasteners. 

If you did not know the Device Name, you will have to search for key words relating to the device. Since the common name is “bone fixation wire”, you may try the key word “wire” or “fixation” or “bone”. You will find, much to your frustration, that only the term “fixation” will also yield the product code JDW. 

The classification name found in 21 CFR Sec. 888.3040 is “Smooth or threaded metallic bone fixation fastener”.  Searching the above site for “threaded” will yield JDW but searching for “fastener” will not.  Confused? So am I! This searching tool could use some improvement! If you have trouble choosing the product code, you can contact the FDA Division of Small Manufacturers, Consumer and International Assistance (DSMICA): dsmica@cdrh.fda.gov; fax 301-443-8818.

The FDA does not send out an annual update for device listing as it does with manufacturer registration. Owner/operators (or their official correspondents) are responsible for keeping data on their listing forms current. To update your listing, simply fill out another form FDA-2892.  You can do this when the change occurs or in June or December.  The type of changes that require an update includes

• When you market a new device with a classification name that is different from one you already listed

• The intended use of the device changes sufficiently that a different classification name would be more appropriate

• You stop marketing all models or variations of your listed device

• You re-market a discontinued device

Information supplied on form FDA-2892 has changed (except for changes in trade name or common or usual name)

 Helpful Hints: 

• Use a new form FDA-2892 for each device you want listed.  Each form has a unique number and, therefore, the FDA cannot accept photocopied forms!

• Remember to remove the last page of the form (It is yellow) before mailing it.  This is your proof of listing since the FDA does not send a confirmation. 

• If you are registering for the first time, send in your manufacturer registration form (form FDA-2891) at the same time as you send in your device listing form FDA-2892. The FDA will not process your registration form without the listing form!

• Your importer cannot submit form FDA-2892 for you. Only the official correspondent can sign the form.

• Periodically check which of your devices are listed by the FDA by going to: Visit

Send your questions and comments to yourFDAconsultant@medisourceasia.com.

Norman F. Estrin, PhD, RAC

November 24, 2002