|Company:||CNS Response Inc|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||April 10, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and
9200 Corporate Blvd
Rockville, MD 20850
APR 10 2008
VIA FEDERAL EXPRESS
President and CEO
2755 Bristol Street, Suite 285
Costa Mesa, CA 92626-5985
Dear Mr. Brandt:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Referenced-EEG® in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed promotional materials available on your website, http://www.cnsresponse.com/ , for Referenced-EEG®. These materials promote the Referenced-EEG® for use in "identifying abnormal patient physiology" and "guiding treatment of mental or addictive illness." The product is therefore a device within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act, because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, the Referenced-EEG® is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 5l5(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81 (b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html . The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Office of Compliance requests that CNS Response immediately cease the dissemination of promotional materials for Referenced-EEG® the same as or similar to those described above. You should take prompt action to correct these violation(s). Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Referenced-EEG® the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Nicole L. Wolanski, at the Food and Drug Administration, Cardiovascular and Neurological Devices Branch Chief, Division of Enforcement B, Office of Compliance, Center for Devices and Radiological Health, 2098 Gaither Road, Rockville, Maryland 20850, facsimile at 240-276-0129. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Referenced-EEG® comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and