FDA’s Approval of a Novel ADHD Devices Sheds Light on Regulatory Process
[Thursday, April 25, 2019]
Last week FDA approved a unique device for the treatment of ADHD in 7-12-year-old children. The process followed for the approval of this first-of-its-kind device highlights the lengths to which FDA may go to approve new devices with unique technologies that can be a useful lesson to other developers of products that meet similar conditions. The device called Monarch external Trigeminal Nerve Stimulation (eTNS) System is a cell-phone sized device that generates a low-level electrical pulse transmitted to a patient’s forehead via a wire connected to a small patch. The low-level electrical nerve stimulation is proposed to send therapeutic signals to the parts of the brain thought to be involved in ADHD. Several interesting regulatory processes were used by the FDA to approve this device. The device was designated low risk and approved via the De Novo 510k process. The approval was based on one placebo-controlled clinical trial with 4 weeks of treatment duration in 62 children with moderate to severe ADHD. The results of the trial were statistically significant although their clinical significance may be marginal. The mechanism of action of the device is not confirmed. In short, the FDA approved a new electrical nerve stimulation device based on a 62 patient, 4-week treatment duration, placebo-controlled study, with questionable clinically significant improvement, and unconfirmed mechanism of action. The case shows how FDA is willing to push the envelope to help the development of new devices with novel technologies for serious conditions. ADHD is a severely debilitating disease particularly in children which compromises the quality of life of the patients and their families alike. More importantly, this is a device intended for pediatric population; there are very few products developed specifically for children. Once again FDA shows that it is willing to work with developers for promising products. The developers, in turn, have to do there share such as do the tests needed and provide reasonable evidence to support market approval, a true win-win both for the regulators and the developers.