The City College of New York, Department of Biomedical Engineering, New York, NY 10031, USA.
The City College of New York, Department of Biomedical Engineering, New York, NY 10031, USA.
Brain Stimul. 2018 Jan-Feb;11(1):134-157. doi: 10.1016/j.brs.2017.10.012. Epub 2017 Oct 17.
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.
我们提出了低功耗非侵入性脑刺激设备的设备标准,这些设备被归类为低输出经颅电刺激 (tES)。低输出 tES 技术应用于调节大脑功能,包括经颅直流电刺激 (tDCS)、经颅交流电刺激 (tACS) 和经颅脉冲电流刺激 (tPCS),引发了关于如何规范技术准入的讨论。在与可比技术相关的法律规定和制造标准方面,已经存在一个全面的框架,包括质量体系 (QS)、风险管理和 (国际) 电工标准 (IEC)。在第 1 部分中,描述了医疗和健康应用的相关法规。虽然监管医疗器械的机构拥有广泛的管辖权,但执法通常侧重于那些具有医疗声明或构成重大风险的设备。无论如何,都适用消费者保护措施,包括对负责任的营销和制造的保护。在本文的第 2 部分中,我们对美国食品和药物管理局 (FDA) 批准的设备的电气输出性能进行了分类,包括非处方 (OTC) 和处方电刺激设备、用于治疗或美容目的的设备以及用于刺激身体或头部的设备。示例包括离子电渗疗法设备、动力肌肉刺激器 (PMS)、颅电刺激 (CES) 和经皮神经电刺激 (TENS) 设备。自 1977 年以来,已有超过 13 个 FDA 产品代码的 1200 多个电刺激器获准上市。传统 tDCS、tACS 和 tPCS 技术的输出特性远低于大多数 FDA 批准设备,包括 OTC 设备和用于头部刺激的设备。这项工程分析表明,就输出性能和现有监管标准而言,公众获得 tDCS、tACS 或 tPCS 不会带来风险,前提是此类设备经过负责任的制造和合法营销。在第 3 部分中,我们为低输出 tES 制定了自愿制造商指南,该指南与当前监管标准一致。我们根据既定的医学工程和科学原则,为确保低输出 tES 设备的设计最大限度地降低风险,同时支持获取和创新,概述了一个强大而透明的技术框架。除了适用的医疗和政府活动外,这份自愿性行业标准 (LOTES-2017) 还在支持公众做出明智决策方面发挥着重要作用。
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