FDA WARNING_LETTER - EEG Info - March 19, 2012

This FDA Warning Letter, dated August 16, 2012, addresses EEG Info, a manufacturer of the EEG NeuroAmp device. An inspection from March 15-19, 2012, revealed the firm's website made claims for the EEG NeuroAmp beyond its 510(k) clearance (K073557) for "biofeedback and relaxation purposes." The website listed "Therapeutic Applications of Neurofeedback" for conditions like Alzheimer's, Autism Spectrum, and Parkinson's Disease.

These disease claims constitute a major change in the device's intended use (21 CFR 807.81(a)(3)(ii)). Consequently, the EEG NeuroAmp is deemed adulterated under section 501(f)(1)(B) of the Act because EEG Info lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). The device is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution for these new uses, as required by section 510(k).

EEG Info's April 25, 2012 response was deemed inadequate. The FDA considers EEG Info a manufacturer under 21 CFR Part 807. The firm must take prompt action to correct these violations. Failure to comply may result in regulatory actions including seizure