Anna Wexler – DIY tDCS Podcast #6 – Regulating tDCS


Anna Wexler is a Ph.D. candidate in the HASTS Program (History, Anthropology, Science, Technology, and Society) at MIT. Her dissertation focuses on the ethical, social and regulatory implications of consumer non-invasive brain stimulation. She is currently a 2015-2016 visiting scholar at the Center for Neuroscience and Society at the University of Pennsylvania. In 2007, Anna graduated from MIT with two Bachelors’ of Science degrees, one in Brain and Cognitive Science and the other in Humanities and Science with a focus in Writing.

Papers of Anna’s we discuss.
A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States
The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals

“Medical Batteries”
The Practice of Medical Electricity: Showing the Most Approved Apparatus, Their Methods of Use, and Rules for the Treatment of Nervous Diseases, More Especially Paralysis and Neuralgia

Front Cover
Fannin & Company, 1869

Harvard Law Professor Peter Barton Hutt

Sally Adee Better Living Through Electrochemistry 2/9/2012 Her blog version of the New Scientist article (now paywalled).
GoFlow (2012
Radiolab 9-Volt Nirvana 6/26/2014
Elif Batuman Electrified 4/6/2015 New Yorker

The challenge of crafting policy for do-it-yourself brain stimulation
Nicholas S Fitz, Peter B Reiner

FDA Proposed Rule Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression

General Wellness: Policy for Low Risk Devices – Draft Guidance for Industry and Food and Drug Administration Staff (PDF – 550KB)

The FDA doesn’t want to regulate wearables, and device makers want to keep it that way (The Verge)

CDPH Warns Consumers Not to Use TDCS Home Device Kit

2 thoughts on “Anna Wexler – DIY tDCS Podcast #6 – Regulating tDCS

  1. Thanks for the podcast and all the great work you BOTH do for the tDCS community!

    As a prospective tDCS vendor, an open question on FDA enforcement we struggle with (while sincerely desiring to stay within bounds) is how much labeling and product claims matter (the honest substantiated kind), or is it drawing a line in the sand. If a device is determined to be marketed for tDCS purposes, can any verbiage (or lack thereof) really convert it from a medical device to a wellness device? Of course, companies’ marketing claims that are unsupported by research that are unscrupulous, misleading, deceptive, fraudulent, or just plain wrong should be little different from other consumer devices regulated by the FTC or CPSC.

    We don’t want to say our device will do “x”, but isn’t it a bit silly and disingenuous if we are afraid to say (and staying conservative) that research is showing “x” or that clinicians are doing “x” with it? Can the device be disassociated from what is being asserted about it in the scientific community? When is a tDCS device not a tDCS device?

    But it’s really not in the public’s interest for the FDA to come in with a heavy hand. tDCS is low risk. Unlike many other medical devices, a tDCS device is pretty simply defined; it either safely delivers up to 2mA DC and performs to its published specs (including whatever bells and whistles), or it does not. And unlike many other medical devices seeking premarket approval, all well behaved tDCS devices can already point to the same publicly available substantial body of research for efficacy and application protocols. And arguably, a properly designed tDCS device is safer than an off-label iontophoresis device that does NOT deliver the same dosage (e.g. up to 4mA), which also calls into question the dosage clause for their proper off-label use.

    The FTC and CPSC already have the tools to enforce a safe tDCS marketplace. Additionally, we live in an Internet age where bad news travels fast, and the public will quickly vet out bad actors – unlike ever before.

    Consumers should be allowed to benefit from tDCS sooner, not later, with economical choices. The restrictions of access, restrictions of choice, time delays, and increased costs that come with over-regulation are unnecessary and not in the public’s interest.

    FDA over-regulation would force prices up, startups out, foster a higher risk DIY black market, slow acceptance, and withhold the benefits from those who really need it, as well as squandering FDA and taxpayer resources.

    Gary S

    • Thanks Gary! My own sense is that with tDCS being so low risk, there’s not much chance of either the FDA or CPSC coming after anyone. Especially considering the scrutiny your fellow tDCS developers put a device through (on the subReddit for example), we can assume that a shoddily made device wouldn’t last on the market for very long. As far as claims go, I would suggest modeling them after some of the larger players like Thync or Halo Neuroscience. I think a bigger challenge for device manufacturers is determining how to bring additional value to a small market that’s already becoming saturated. What will differentiate one device over another? Good luck with Zwik!

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