Medical Application: Regulatory Landscape – Agencies

Distinct regulatory agencies currently govern the administration of legal frameworks for each of these classes. Binding regulations for medical neurotechnologies are enforced in America by the Food and Drug Administration (FDA) and in Europe by the European Union. Additionally, the World Health Organization (WHO) is mandated to encourage the national adoption of regulatory practices in its member states, which currently …

Medical Application: Regulatory Landscape – Statutory Types

Legal frameworks for regulation of medical devices have traditionally been classed in one of three ways, binding regulation, standards, and soft law. Binding regulations are legally enforceable statutes required for the development and use of technologies in a medical setting. Standards provide for safety and risk control in technology use through the establishment of acceptable design practices and tolerances. Soft …

Medical Application: Regulatory Landscape – Principles

Legal frameworks for medical neurotechnologies can be expected to find their normative origin in universally agreed upon principles that have been developed to guide biomedical practice and bioethics. The 2005 Universal Declaration on Bioethics and Human Rights, for example, formulates a set of norms to guide biomedical practice, assigning first place to a principle of respect for “human dignity, human …

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 ...