Archived Letters to Industry 2012

• CDRH Clarifies Classification of EEG Devices

December 13, 2011

Dear Electroencephalograph Device Manufacturer:

This letter is to advise you that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has updated the product codes used to classify and describe electroencephalograph (EEG) devices, which are regulated under 21 CFR 882.1400. Specifically, we have created 11 new product codes (see comparison table attached at the end of this letter) in order to provide greater clarity and detail regarding the EEG device type. The full list of product codes and respective definitions may be found in the table below or in the CDRH Classification Database at the following weblink:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.

Today's EEG devices have many more features than the devices that were in existence at the creation of the first EEG product code, GWQ, in the late 1970s. Contemporary designs of EEG devices may include classic features, such as standard full-montage EEG acquisition systems or polysomnography devices, but they may also include more novel features, such as automatic event detection software or source localization software. The 11 new product codes will allow CDRH to better distinguish among the different types of EEG devices marketed in the United States (U.S.) and more effectively regulate EEG devices in both the premarket and postmarket settings.

Import Paperwork -What You Must Do

When preparing import paperwork, including your FDA Listing, you must continue to reference the product code(s) that is/are found on your original 510(k) letter of substantial equivalence (SE) to avoid delays at the port of entry into the U.S. Do not use the "New Product Codes" (described in the table below) on any FDA submissions until after FDA has sent you a corrected SE letter which lists the updated product code(s) for your 510(k).

CDRH Activities and Next Steps

CDRH has reviewed all 510(k)s cleared under 21 CFR 882.1400 and has identified the 510(k)s for which we plan to update the product code(s). We are currently in the process of issuing corrected SE letters to holders of 510(k)s whose product code(s) need to be updated. The corrected SE letters will be issued to the holders of the 510(k)s at the time of clearance (i.e., they will be sent to the address that appears on the original SE letter). Upon issuance of the corrected SE letter, we will also update our 510(k) database to reflect this change. The updated product code(s) will only be put into effect for your device after CDRH has issued the corrected SE letter that contains the updated product code(s).

If you market an EEG device for which you are not the original 510(k) holder, you will likely not receive the corrected SE letter because you are not the point of contact on record. If you are the current holder of a 510(k) that you believe may be affected by this change but were not the original holder of the 510(k), we recommend that you contact Marjorie Shulman, Acting Director of the 510(k) Staff, via e-mail, at marjorie.shulman@fda.hhs.gov to ask if your product codes have changed and, if relevant, request a copy of the corrected SE letter for your 510(k) so you know which specific new product code(s) have been assigned to your device. The 510(k) staff will then fax a copy of it directly to you.

Need Further Clarifications?

If you need further clarification on this issue or any assistance in complying with FDA regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) by email at DSMICA@CDRH.FDA.GOV or by phone at 1 (800) 638-2041.

Sincerely yours,

Elias Mallis
Director
Division of Small Manufacturers, International and Consumer Assistance
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Attachment: Table of New Product Codes and Definitions for 21 CFR 882.1400