FDA WARNING_LETTER - NCS Pearson

On August 20, 2015, the FDA issued a Warning Letter to Pearson Education, Inc. regarding their Quotient ADHD System. The FDA determined the device is being marketed in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The Quotient ADHD System is deemed adulterated under section 501(f)(1)(B) of the Act because Pearson Education, Inc. lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) for introducing the device into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)).

Specifically, the device, originally cleared as the OPTAx System (K020800) to aid in ADHD assessment, is now promoted for new intended uses, including monitoring treatment response, optimizing treatment, and assessing treatment effectiveness. These new indications, such as "monitor response to treatment" and "optimize treatment in weeks instead of months," fall outside the cleared indications and require new FDA clearance or approval.

Pearson Education, Inc. was instructed to immediately cease activities resulting in the misbranding or adulteration of the Quotient ADHD System. The firm was required to respond in writing within fifteen business days, detailing corrective actions, a plan to prevent recurrence, and a timetable for implementation. Failure to comply could result in regulatory