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J Law Biosci. 2015 Oct 12;2(3):669-696. eCollection 2015 Nov.

A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States.

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1
Department of Science, Technology and Society, E51-070, Massachusetts Institute of Technology, 77 Massachusetts Ave, Cambridge, MA 02141, USA.

Abstract

Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device-which focuses on the intended use of the device rather than its mechanism of action-is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA's jurisdiction over medical devices in cases where the meaning of 'intended use' has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a 'regulatory gap,' there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States.

KEYWORDS:

food and drug law; human enhancement; medical devices; neuroscience; regulation; transcranial direct current stimulation (tDCS)

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