Neuro Kinetics, Inc. – FDA Warning Letter, May 17, 2013

On September 11, 2013, the FDA issued a Warning Letter to Neuro Kinetics, Inc. following an inspection from May 13-17, 2013. The inspection found that the I-Portal Neuro Otologic Test Center (NOTC), I-Portal 4D Video Oculography System (VOG), and I-Portal Video Nystagmography System (VNG) are medical devices.

The I-Portal NOTC was deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption. It was also misbranded under section 502(o) for failure to notify the FDA of its intent to introduce the device into commercial distribution, specifically regarding the distribution of (b)(4) CDs with the NOTC. The FDA stated that providing normative data, such as on these CDs, constitutes a significant change to the device's technological characteristics, requiring a new marketing application.

Neuro Kinetics, Inc. was instructed to take prompt action to correct these violations. Failure to do so could result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The firm was required to respond in writing within fifteen business days, detailing corrective steps, prevention plans, and a timetable for implementation. A regulatory meeting with the FDA was also requested. The letter emphasized that