NeuroTrax Israel Ltd. – FDA Warning Letter, Mar 15, 2012

The FDA issued a Warning Letter to NeuroTrax Israel Ltd. after discovering the firm was marketing its MindStreams Cognitive Health Assessment Software in the U.S. without required marketing clearance or approval. The FDA determined MindStreams is a Class III device under Section 201(h) and 513(f) of the Federal Food, Drug, and Cosmetic Act, intended for diagnosis or affecting body function. The firm's marketing of this device without premarket clearance or approval constitutes a violation of the Act. Furthermore, the device is considered adulterated under Section 501(f)(1)(B) because NeuroTrax lacks an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE). The FDA had previously issued a "Not Substantially Equivalent" determination for the device's 510(k) submission in 2007, classifying it as Class III, a decision upheld after the firm's appeal in 2008. NeuroTrax is required to submit a written response within 15 working days, detailing its plan to cease marketing and promotion of MindStreams as a device without premarket approval, including a list of all promotional materials. Failure to promptly correct these violations may result in further regulatory action, impact federal contracts, and prevent the issuance of Certificates to Foreign Governments.