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KMID : 1011120230160030153
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Bioethics Policy Studies
2023 Volume.16 No. 3 p.153 ~ p.195
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FDA Regulations and Implications for Brain Stimulators - A Comparative Legal Study on the Regulation of Medical Devices in Korea -
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Park Jeong-Yeon
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Abstract
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With the recent development of neuroscience and technology, brain stimulators used for medical purposes are also being advanced and types are diversified. In order for brain stimulators to be used for medical purposes, they must go through licensing procedures under the Medical Device Act, but in the case of new devices that are differentiated from existing technologies, it is not clear whether they are medical devices, grades, and items. Moreover, in the case of low-level non-invasive brain stimulators aimed at improving concentration, not for medical purposes, it is unclear whether they are included in the regulation under the Medical Device Act even though they do not directly indicate the medical purpose. On the other hand, brain stimulators are not known for the side effects of long-term use, and it is unclear whether the method of stimulating brain nerves causes other harmful effects to the human body, so continuous risk management and research are needed.
In addition, brain stimulators are often used in addition or in parallel if there are no other treatment methods or are ineffective, and through this process, the indication is gradually expanded or the effectiveness is proven and stabilized. In this regard, regulations on the use of research purposes or use outside of permission should also be discussed. In order to respond realistically and actively to these problems, it is necessary to look at the regulation of brain stimulators in the United States. The regulation of medical devices in the United States has a strong impact on Korea’s policies and legislation, so it presents us with various implications.
For this purpose, I first derived regulatory problems under the Medical Device Act for brain stimulators in Korea based on my understanding of the types and characteristics of brain stimulators (II). Furthermore, I explained the U.S. FDA’s medical device regulation system and reviewed how brain stimulators are regulated under the FDCA (III). As an implication of legislative comparison, I presented the direction of regulation and level of regulation under the Medical Device Act on brain stimulators, focusing on the interpretation of definition regulations for medical devices in the United States and Korea (IV). Finally, I reviewed the issue of improving licensing procedures and using off-label in consideration of the benefits of using brain stimulators, while mentioning the need for risk management after licensing (V).
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KEYWORD
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brain stimulator, brain stimulation, tDCS, TMS, BCI, medical devices, regulation, licensing
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