A significant number of new and established neurotechnology firms are entering the consumer products market, as we cover in our report on the 2015 CES International show on page 7 of this issue. Given the rapidly growing market for consumer neurotech, the industry would be well served by coherent and specific guidelines on when a new product does or does not need FDA approval. Though many questions still remain, The FDA’s Center for Devices and Radiological Health at least addressed the issue earlier this month when they released a draft guidance about low-risk general wellness products, which the agency does not intend to regulate.
In their non-binding, draft document, CDRH defines general wellness products as products that meet two factors. First, they must be intended for only general wellness use, and second, they must present a very low risk to users’ safety. The document lists examples of wellness products such as “exercise equipment, audio recordings, video games, software programs, and other products that are commonly, though not exclusively, available from retail establishments.”
Still unanswered and of profound interest to consumer headset manufacturers is the question of how the FDA will treat brain stimulation devices such as Halo Neuroscience’s forthcoming tDCS device and Thync’s neurosignaling headset. At first glance, both firms would seem to be in good shape since they do not claim to treat a specific disorder but rather promote well-being, relaxation, or other mental states. But the gotcha for these devices is that they emit electromagnetic energy and thus potentially fall into CDRH’s realm of safety oversight, regardless of the presence or absence of medical claims.
This publication has addressed the issue with the CEOs of both Halo and Thync and both believe that their interaction with FDA will be smooth and straightforward. The need for a PMA is unlikely, in our view, given the existence of comparable medical products with higher energy levels and given the FDA’s recent backtracking on reclassification of cranial electrical stimulation devices [NBR Jun14 p2]. But it’s also unlikely that the FDA will pass on regulating consumer tDCS devices altogether, although at least one vendor of wellness devices, Magneceutical Health, did succeed in getting a letter from FDA exempting their low-level magnetic stimulation device [NBR Sep11 p7].
Hopefully, the agency will offer specific and reasonable guidance on this issue, perhaps including an energy threshold. If so, we hope they will consider the typical amount of electromagnetic energy delivered to the craniums of cell phone users on any given day. FDA should certainly seek to ensure the safety of consumer neurotech users. But they should do so in a logical, consistent, and timely manner.
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