FDA WARNING_LETTER - CNS Response Inc

The FDA issued a Warning Letter to CNS Response for marketing the "Referenced-EEG?" in the U.S. without required marketing clearance or approval. The FDA's Office of Compliance reviewed promotional materials on the firm's website, http://www.cnsresponse.com/, which promoted the device for "identifying abnormal patient physiology" and "guiding treatment of mental or addictive illness."

The FDA determined the "Referenced-EEG?" is a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act due to its intended diagnostic and treatment uses. The firm failed to obtain premarket approval (PMA) or an investigational device exemption (IDE), rendering the device adulterated under section 501(f)(1)(B) of the Act. Additionally, the device is misbranded under section 502(o) because CNS Response did not notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

CNS Response is required to immediately cease dissemination of promotional materials for the "Referenced-EEG?" and submit a written response within 15 working days. The response must detail their compliance intent, list all similar promotional materials, and explain their plan for discontinuing their use. Failure to correct these violations may result in regulatory actions including seizure, injunction, and/or civil money penalties.