FDA Warns Devicemaker Over Marketing of ADHD System

The FDA hit Massachusetts-based NSC Pearson with a warning letter for marketing an attention deficit hyperactivity disorder system without marketing clearance or approval.

According to the Aug. 20 letter, the company promoted the Quotient ADHD System — originally called OPTAx — as a means to analyze shifts in attention state, monitor response to treatment, optimize treatment in weeks instead of months and evaluate the effectiveness of new or ongoing treatments.

NSC also claimed the device could help to assess whether patients were getting the right intervention and to achieve clinical efficacy sooner. All of these claims “constitute a major change or modification to its intended use for which your firm lacks clearance or approval,” the letter says.

The Quotient ADHD System is cleared to provide clinicians with objective measurements of hyperactivity, impulsivity and inattention in assessing attention deficit hyperactivity disorder. Results should be interpreted only by qualified professionals, the FDA says.

Pearson spokeswoman Laura Howe tells IDDM that the company is taking steps to ensure all of its promotional materials are in compliance with federal regulations.

The warning letter is available at www.fdanews.com/092815-warning-pearson.pdf. — Elizabeth Hollis