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Fitz and Reiner describe the widespread appeal of transcranial direct current stimulation (tDCS) as an all-purpose cognitive enhancer.1 Relatively safe, cheap and effective, tDCS has been met with excitement by academics, journalists and private individuals hoping to purchase or construct equipment for home use. Devices can now easily be bought online without regulation or oversight.2 Urging a more cautious approach to claims about the safety of tDCS, Fitz and Reiner offer recommendations to guide balanced discourse and call on all stakeholders to contribute to policy debate. We respond to this call by proposing a model for the regulation of tDCS devices. We propose that cognitive enhancement devices (CEDs), such as tDCS and neurofeedback equipment, should be regulated in the same way as medical devices (MDs) with the further suggestion that a ‘low-risk exemption’ should be incorporated for MDs and CEDs alike. This model, we believe, is very much in the spirit of the ‘managed technological optimism’ Fitz and Reiner advocate.
Narrowing down the regulatory options
As Fitz and Reiner point out, devices marketed for cognitive enhancement are not covered by any existing legislation in either the EU or the USA, other than that which covers general product safety. The EU's General Product Safety Directive, for example, only sets general requirements and does not make provision for pre-market assessment.i Devices marketed for enhancement purposes are therefore not held to the rigorous standards set for MDs since they do not fall within the definition of an MD set out in the Medical Devices Directive (MDD)ii. Given the safety concerns Fitz and Reiner raise, and the emerging market for tDCS, we agree that maintaining the status quo is not a tenable option—some regulation is needed. However, we also share their view that the optimum regulatory framework would be one that acknowledges the potential …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
↵i Directive 2001/95/EC
↵ii Directive 93/42/EEC; the same is true for the definition of ‘medical device’ in the Title 21 Code of Federal Regulations (CFR) Part 201(h)—both identify medical devices as those devices that are intended by the manufacturer to be used for treatment or diagnosis.
↵iii European Commission (2012), Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009.