Using Our Cranium
It isn’t often that this publication can report on changes in regulatory policy at the FDA that benefit the neurotechnology industry. But that is indeed what seems to be the case with cranial electrical stimulation. Earlier this month, the federal agency backtracked on its previous decision to classify the surface stimulation systems as class III, rather than class II devices [NBR May13 p2]. The decision, had it been implemented, would have been catastrophic for the surface brain stimulation industry and the emerging fields of transcranial direct current and transcranial alternating current stimulation.
Two firms that are certain to benefit from the FDA withdrawal of the proposed reclassification are Fisher Wallace Laboratories in New York and Electromedical Products International in Mineral Wells, TX. Both firms manufacture CES devices that have been used to treat neurological disorders such as depression, insomnia, and chronic pain. A large number of peer-reviewed studies have been published over the years supporting the safety and efficacy of CES for treating a number of neurological disorder. Among the prestigious researchers to have authored papers on CES therapies is Felipe Fregni from Harvard University, a widely recognized expert on noninvasive brain stimulation.
Fisher Wallace CEO Chip Fisher played a leading role in getting the FDA decision reversed, gathering scientific evidence in support of CES. Electromedical Products International chairman Daniel Kirsch also fought hard on behalf of CES. “We welcome the action taken by the FDA, which reflects the overwhelming evidence of absolute safety and effectiveness of CES treatment for anxiety, depression, and insomnia,” he said. “This is a battle we have fought with the FDA for the past 22 years, and are pleased that we can now move forward with the proper classification.” It has been the position of Electromedical Products International that such devices never should have been designated as class III, which is reserved for life-sustaining or life-support devices, such as surgical implants.
In their statement, the FDA announced it was withdrawing the proposed rule and proposed order to call for a PMA for CES devices and would be establishing special controls in addition to general controls, but did not specify what those controls would be.
It remains to be seen what the regulatory environment will be for brain stimulation devices once the FDA offers more specific guidance on these special controls. With a host of new vendors of tDCS and tACS systems soon heading to market, and a variety of new applications for noninvasive brain stimulation, it will be important that the FDA establish guidelines that are reasonable and backed by science. In the meantime, however, the neurotech industry should be pleased by this turn of events at the FDA.
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