Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk

Marom Bikson, Bhaskar Paneri, Andoni Mourdoukoutas, Zeinab Esmaeilpour, Bashar W. Badran, Robin Azzam, Devin Adair, Abhishek Datta, Xiao Hui Fang, Brett Wingeier, Daniel Chao, Miguel Alonso-Alonso, Kiwon Lee, Helena Knotkova, Adam J. Woods, David Hagedorn, Doug Jeffery, James Giordano, William Tyler

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.

Original languageEnglish (US)
JournalBrain Stimulation
DOIs
StateAccepted/In press - 2017

Fingerprint

Prescriptions
Industry
Equipment and Supplies
United States Food and Drug Administration
Transcranial Direct Current Stimulation
Marketing
Head
Electric Stimulation Therapy
Technology
Transcutaneous Electric Nerve Stimulation
Iontophoresis
Deep Brain Stimulation
Risk Management
Brain
Cosmetics
Muscles

Keywords

  • FDA clearance
  • FDA product codes
  • Limited output tES
  • Manufacturer guidance
  • Over-the-counter device
  • Prescription medication
  • Regulatory standards

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biophysics
  • Clinical Neurology

Cite this

Limited output transcranial electrical stimulation (LOTES-2017) : Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. / Bikson, Marom; Paneri, Bhaskar; Mourdoukoutas, Andoni; Esmaeilpour, Zeinab; Badran, Bashar W.; Azzam, Robin; Adair, Devin; Datta, Abhishek; Fang, Xiao Hui; Wingeier, Brett; Chao, Daniel; Alonso-Alonso, Miguel; Lee, Kiwon; Knotkova, Helena; Woods, Adam J.; Hagedorn, David; Jeffery, Doug; Giordano, James; Tyler, William.

In: Brain Stimulation, 2017.

Research output: Contribution to journalArticle

Bikson, M, Paneri, B, Mourdoukoutas, A, Esmaeilpour, Z, Badran, BW, Azzam, R, Adair, D, Datta, A, Fang, XH, Wingeier, B, Chao, D, Alonso-Alonso, M, Lee, K, Knotkova, H, Woods, AJ, Hagedorn, D, Jeffery, D, Giordano, J & Tyler, W 2017, 'Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk', Brain Stimulation. https://doi.org/10.1016/j.brs.2017.10.012
Bikson, Marom ; Paneri, Bhaskar ; Mourdoukoutas, Andoni ; Esmaeilpour, Zeinab ; Badran, Bashar W. ; Azzam, Robin ; Adair, Devin ; Datta, Abhishek ; Fang, Xiao Hui ; Wingeier, Brett ; Chao, Daniel ; Alonso-Alonso, Miguel ; Lee, Kiwon ; Knotkova, Helena ; Woods, Adam J. ; Hagedorn, David ; Jeffery, Doug ; Giordano, James ; Tyler, William. / Limited output transcranial electrical stimulation (LOTES-2017) : Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. In: Brain Stimulation. 2017.
@article{05b14b57755c437c81eacfdf4a5396fe,
title = "Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk",
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 = "FDA clearance, FDA product codes, Limited output tES, Manufacturer guidance, Over-the-counter device, Prescription medication, Regulatory standards",
author = "Marom Bikson and Bhaskar Paneri and Andoni Mourdoukoutas and Zeinab Esmaeilpour and Badran, {Bashar W.} and Robin Azzam and Devin Adair and Abhishek Datta and Fang, {Xiao Hui} and Brett Wingeier and Daniel Chao and Miguel Alonso-Alonso and Kiwon Lee and Helena Knotkova and Woods, {Adam J.} and David Hagedorn and Doug Jeffery and James Giordano and William Tyler",
year = "2017",
doi = "10.1016/j.brs.2017.10.012",
language = "English (US)",
journal = "Brain Stimulation",
issn = "1935-861X",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Limited output transcranial electrical stimulation (LOTES-2017)

T2 - Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk

AU - Bikson, Marom

AU - Paneri, Bhaskar

AU - Mourdoukoutas, Andoni

AU - Esmaeilpour, Zeinab

AU - Badran, Bashar W.

AU - Azzam, Robin

AU - Adair, Devin

AU - Datta, Abhishek

AU - Fang, Xiao Hui

AU - Wingeier, Brett

AU - Chao, Daniel

AU - Alonso-Alonso, Miguel

AU - Lee, Kiwon

AU - Knotkova, Helena

AU - Woods, Adam J.

AU - Hagedorn, David

AU - Jeffery, Doug

AU - Giordano, James

AU - Tyler, William

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - FDA clearance

KW - FDA product codes

KW - Limited output tES

KW - Manufacturer guidance

KW - Over-the-counter device

KW - Prescription medication

KW - Regulatory standards

UR - http://www.scopus.com/inward/record.url?scp=85032921388&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85032921388&partnerID=8YFLogxK

U2 - 10.1016/j.brs.2017.10.012

DO - 10.1016/j.brs.2017.10.012

M3 - Article

C2 - 29122535

AN - SCOPUS:85032921388

JO - Brain Stimulation

JF - Brain Stimulation

SN - 1935-861X

ER -