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 have widely variable legal statutes, and the harmonization of legal instruments across national boundaries.

In the United States, FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who use clinical articles or participate in clinical investigations involving medical articles, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including, among others, medical devices and systems for human use. This is generally taken to mean that the FDA is responsible for assuring that medical devices available in the United States are safe and effective throughout their total product lifecycle. The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in the health care system.

Food and Drug Administration (United States)
The scope of FDA’s regulatory authority is very broad. With regard to medical devices FDA prioritizes safety, verifiability, and accountability. Accordingly, medical devices are stratified according to a risk classification scheme from Class I – III, with Class III posing the greatest level of risk, e.g., Medtronic deep brain stimulation device (DBS) (approved 1997) and Abbott’s Infinity directional DBS device (approved 2020). FDA is publicly advised through its FDA Advisory Committee System, where questions of health, disease, and ethical value are likely to be posed (FDA).

European Medicines Agency (European Union)
The Medical Device Regulation includes comprehensive legislation for a range of medical and borderline medical products that includes a required conformity assessment that determines the quality, safety, and performance of the device. These conformity assessments are carried out by accredited bodies designated by EU Member States. Special regulations exist for medicinal products used in conjunction with medical devices, in vitro diagnostics, devices that are systemically absorbed, high risk devices, and borderline medical devices where there is some uncertainty as to which regulatory framework applies (EMA).

World Health Organization
Regulation is directed to ensuring public health benefit and the safety of patients, health care workers and the community. WHO’s mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29, is “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization”. WHO assists in harmonization of legal instruments.