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
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...
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Elsevier
2018-01-01
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Series: | Brain Stimulation |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S1935861X17309452 |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 J. Tyler |
spellingShingle |
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 J. Tyler 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 Limited output tES FDA clearance Over-the-counter device Prescription medication FDA product codes Manufacturer guidance |
author_facet |
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 J. Tyler |
author_sort |
Marom Bikson |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Elsevier |
series |
Brain Stimulation |
issn |
1935-861X |
publishDate |
2018-01-01 |
description |
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. |
topic |
Limited output tES FDA clearance Over-the-counter device Prescription medication FDA product codes Manufacturer guidance |
url |
http://www.sciencedirect.com/science/article/pii/S1935861X17309452 |
work_keys_str_mv |
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doaj-d244961b58744a79928e5e41dfec7aad2021-03-19T07:11:20ZengElsevierBrain Stimulation1935-861X2018-01-01111134157Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low riskMarom Bikson0Bhaskar Paneri1Andoni Mourdoukoutas2Zeinab Esmaeilpour3Bashar W. Badran4Robin Azzam5Devin Adair6Abhishek Datta7Xiao Hui Fang8Brett Wingeier9Daniel Chao10Miguel Alonso-Alonso11Kiwon Lee12Helena Knotkova13Adam J. Woods14David Hagedorn15Doug Jeffery16James Giordano17William J. Tyler18The City College of New York, Department of Biomedical Engineering, New York, NY 10031, USA; Corresponding author.The City College of New York, Department of Biomedical Engineering, New York, NY 10031, USAThe City College of New York, Department of Biomedical Engineering, New York, NY 10031, USAThe City College of New York, Department of Biomedical Engineering, New York, NY 10031, USAU.S. Army Research Laboratory, Aberdeen Proving Ground, MD, USA; Department of Psychology, University of New Mexico, Albuquerque, NM, USACaputron, New York, NY, USAThe City College of New York, Department of Biomedical Engineering, New York, NY 10031, USASoterix Medical Inc., New York, NY 10001, USAThe City College of New York, Department of Biomedical Engineering, New York, NY 10031, USAHalo Neuroscience Inc., San Francisco, CA 94103, USAHalo Neuroscience Inc., San Francisco, CA 94103, USAHarvard Medical School, Berenson-Allen Center for Noninvasive Brain Stimulation, Division of Cognitive Neurology, Boston, MA, USAYbrain Inc., Sampyeong-dong, Seongnam-si, South KoreaMJHS Institute for Innovation in Palliative Care, New York, NY, USA; Department of Family and Social Medicine, Albert Einstein College of Medicine, The Bronx, NY, USACenter for Cognitive Aging and Memory, McKnight Brain Institute, Department of Clinical and Health Psychology, University of Florida, USAEvoke Neuroscience Inc., Jacksonville, NC, USAThync Inc., Los Gatos, CA 95030, USADepartment of Neurology and Neuroethics Studies Program, Pellegrino Center for Clinical Bioethics, Georgetown University Medical Center, Washington, DC, USAArizona State University, School of Biological and Health Systems Engineering, Tempe, AZ 85287, USAWe 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.http://www.sciencedirect.com/science/article/pii/S1935861X17309452Limited output tESFDA clearanceOver-the-counter devicePrescription medicationFDA product codesManufacturer guidance |