Perspectives of Current FDA Guidance on BCI Technology

Abstract

The research and development of Brain Computer Interface (BCI) devices, like many technologies, has arguably progressed much quicker than the guidance produced by public regulatory bodies such as the Food and Drug Administration (FDA). While other institutions, such as the Federal Trade Commission or the Government Accountability Office, may regulate BCI technology, the FDA represents a high-profile exemplar both in public perception and in establishing guidance for industry standards (Food and Drug Administration, Advancing regulatory science at FDA: focus areas of regulation (FARS), U.S Food and Drug Administration, Silver Spring, 2021). However, in the current BCI guidance, the FDA explicitly acknowledges that it is concerned only with implanted technologies and only those intended for clinical, therapeutic applications for either amputees or paralyzed individuals (Food and Drug Administration, Implanted brain–computer interface devices for patients with paralysis or amputation-non-clinical testing and clinical considerations; guidance for industry and food and drug administration staff, U.S Food and Drug Administration, Silver Spring, 2021). This significantly limits the FDA’s scope in BCI regulation and the extent to which the FDA guidance can be used as a template for other applications of the technology. While the approach is consistent with intentions to reduce the burden of regulatory approvals, such deregulation could potentially undermine the FDA’s role in ensuring the safety and effectiveness of BCI technology. This chapter will explore the current FDA guidance on BCIs and the implications of this guidance as a model for the regulation of broad applications of BCI technology.