Medical Application: Regulatory Landscape overview

A fundamental aspect of medical neurotechnologies is their intervention within the nervous system, including the human brain. Developers of medical neurotechnologies must therefore confront the deeply ethical nature that such intervention entails. Accordingly, while existing regulatory agencies have traditionally limited prioritization to the risk and safety issues of medical devices, ethical and societal concerns associated with the creation, development, and application of advanced, medical neurotechnologies can be expected to present novel or additional ethical, social, and legal challenges requiring more extensive regulatory oversight. Addressing these challenges is likely to involve the formation of new or more comprehensive statutory frameworks needed for overseeing the generation and application of these technologies.