Recently, FDA released a Warning Letter regarding the Quotient ADHD Systemis, a software program made by Pearson Education, Inc. that was cleared by FDA in 2002 for clinicians to use as a device to provide “objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD.”
However, during routine monitoring and oversight, FDA’s Center for Device and Radiological Health (CDRH) reviewed the company’s website and identified claims that allegedly promoted the product for unapproved uses. Specifically, CDRH maintained that the website provided evidence that the software “is intended to measure motion and analyze shifts in attention state, monitor response to treatment, help to optimize treatment in weeks instead of months, and help to determine the effectiveness of a new treatment or continued effectiveness of ongoing treatment when clinically indicated.” FDA cited statements on the website such as
- “…monitor response to treatment …”
- “… objectively measures micro-motion and analyzes shifts in attention state”
- “… helps to achieve clinical efficacy sooner.”
CDRH asserted that these statements “would constitute a major change or modification to its intended use for which [the] firm lacks clearance or approval.” As a result, FDA maintained in its Warning Letter that the company caused the Quotient ADHD Systemis to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because Pearson did not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.
Further, FDA took the position that the Quotient ADHD Systemis was misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because Pearson introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). As a result, CDRH requested that Pearson immediately cease making these product claims.
This recent enforcement action follows a number of similar actions taken by FDA and the FTC against software manufacturers and developers. For example, in late January 2015, the Federal Trade Commission (FTC) entered into a Consent Order with Focus Education, LLC, based on Attention Deficit Hyperactivity Disorder (ADHD) improvement claims the company made about an educational software game known as the “ifocus System.” As we previously described, the FTC alleged that Focus Education made express and implied claims that the ifocus System was “scientifically proven” to cause permanent improvements in children’s focus, memory, attention, behavior, and/or school performance, including in children with ADHD. The FTC asserted in its administrative complaint that such claims were false and misleading and were not adequately substantiated with competent and reliable scientific evidence.
Accordingly, this Warning Letter underscores the need for software manufacturers and developers to implement detailed policies and procedures regarding promotional materials and statements made by the company. Such processes are particularly critical for online advertising or promotion because such materials are available to wide audiences and easily identified by government authorities such as FDA. As FDA indicates, written statements on company websites have the potential to constitute “major changes or modifications” to the intended use of a device, thereby causing it to be misbranded. Thus, companies should implement robust processes and systems that govern the creation, review, substantiation, and approval of advertising and promotional materials prior to their use, and involve legal, regulatory, and medical personnel in the process.
As stakeholders continue to develop and provide such software to clinicians, and patients and families depend on their use for treatment, FDA and the FTC will continue to be vigilant about product claims and statements, particularly in areas affecting children.