Highlights
- •Illustrated that limited output tES devices have specifications that are below most FDA cleared devices.
- •Argued that limited output tES devices would not introduce risk if they are responsibly manufactured and legally marketed.
- •Detailed voluntary manufacturer guidance for limited output tES to minimize risks, while supporting access and innovation.
- •Outlined industry guidance that are consistent with and expand on the current regulatory standards.
- •Classified FDA product codes for more than 1200 electrical stimulators that have been FDA cleared for marketing since 1977.
Abstract
We present device standards for low-power non-invasive electrical brain stimulation
devices classified as limited output transcranial electrical stimulation (tES). Emerging
applications of limited output tES to modulate brain function span techniques to stimulate
brain or nerve structures, including transcranial direct current stimulation (tDCS),
transcranial alternating current stimulation (tACS), and transcranial pulsed current
stimulation (tPCS), have engendered discussion on how access to technology should
be regulated. In regards to legal regulations and manufacturing standards for comparable
technologies, a comprehensive framework already exists, including quality systems
(QS), risk management, and (inter)national electrotechnical standards (IEC). In Part
1, relevant statutes are described for medical and wellness application. While agencies
overseeing medical devices have broad jurisdiction, enforcement typically focuses
on those devices with medical claims or posing significant risk. Consumer protections
regarding responsible marketing and manufacture apply regardless. In Part 2 of this
paper, we classify the electrical output performance of devices cleared by the United
States Food and Drug Administration (FDA) including over-the-counter (OTC) and prescription
electrostimulation devices, devices available for therapeutic or cosmetic purposes,
and devices indicated for stimulation of the body or head. Examples include iontophoresis
devices, powered muscle stimulators (PMS), cranial electrotherapy stimulation (CES),
and transcutaneous electrical nerve stimulation (TENS) devices. Spanning over 13 FDA
product codes, more than 1200 electrical stimulators have been cleared for marketing
since 1977. The output characteristics of conventional tDCS, tACS, and tPCS techniques
are well below those of most FDA cleared devices, including devices that are available
OTC and those intended for stimulation on the head. This engineering analysis demonstrates
that with regard to output performance and standing regulation, the availability of
tDCS, tACS, or tPCS to the public would not introduce risk, provided such devices
are responsibly manufactured and legally marketed. In Part 3, we develop voluntary
manufacturer guidance for limited output tES that is aligned with current regulatory
standards. Based on established medical engineering and scientific principles, we
outline a robust and transparent technical framework for ensuring limited output tES
devices are designed to minimize risks, while also supporting access and innovation.
Alongside applicable medical and government activities, this voluntary industry standard
(LOTES-2017) further serves an important role in supporting informed decisions by
the public.
Keywords
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Article info
Publication history
Published online: October 17, 2017
Accepted:
October 15,
2017
Received in revised form:
September 16,
2017
Received:
April 4,
2017
Identification
Copyright
© 2017 Elsevier Inc. All rights reserved.
