|Issuer:||Los Angeles District Office|
|Issued:||Aug. 16, 2012||Closed:||April 9, 2013|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Los Angeles District
VIA UNITED PARCEL SERVICE
August 16, 2012
Kurt R. Othmer
6400 Canoga Avenue, Suite 210
Woodland Hills, CA 91367
Dear Mr. Othmer:
During an inspection of your firm located in Woodland Hills, California, on March 15, 2012, through March 19, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EEG NeuroAmp. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device 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 to affect the structure or any function of the body.
We received a response from Mr. Harry Nelson, counsel to EEG Info, dated April 25, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to the noted violation. The violation includes, but is not limited to, the following:
The EEG NeuroAmp (K073557) was cleared under section 510(k) of the Act, 21 U.S.C. § 360(k), for the following intended use: “The EEG Neuroamp is intended for biofeedback and relaxation purposes.”
Your firm’s website, at http://www.eeginfo.com, includes claims that are not within the 510(k) clearance of the EEG NeuroAmp. For example, your website contains a webpage with a header “Therapeutic Applications of Neurofeedback.” Under the header, you list, among others, the following conditions: Alzheimer's, Amnesia, Autism Spectrum, Crohn's Disease, Multiple Sclerosis, Parkinson's Disease, Schizophrenia, and Traumatic Brain Injury. These disease claims constitute a major change or modification in the intended use of the device, under 21 CFR 807.81(a)(3)(ii).
The EEG NeuroAmp is therefore adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its 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) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm . The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
We reviewed your firm’s response and conclude that it is not adequate. Because of the activities that EEG Info engaged in with respect to the EEG NeuroAmp, your firm is considered a manufacturer under 21 CFR Part 807.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Blake Bevill, Director Compliance Branch
United States Food and Drug Administration
Irvine, CA 92612
If your firm has any questions about the contents of this letter, please contact: Jessica Mu, Compliance Officer, via telephone at 949-608-4477 or via fax at 949-608-4401.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Alonza E. Cruse
Los Angeles District
Cc: Ingeborg Small
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435