THE FOOD AND DRUG ADMINISTRATION AND THE FUTURE OF THE BRAIN-COMPUTER INTERFACE: ADAPTING FDA DEVICE LAW TO THE CHALLENGES OF HUMAN-MACHINE ENHANCEMENT

摘要

Brain-computer interfaces in general, and neuroelectronic user devices in particular, are still in their infancy. Vast challenges remain in making these devices both commercially and technologically feasible. In particular, it remains to be seen whether neuroelectronic interfaces can overcome the current challenges of biocompatibility and long-term signal degradation, or whether other less invasive technologies such as EEGs and myoelectric interfaces can drastically increase in performance. Only time will tell if these technologies fulfill their potential, and only time will tell how and if they will impact our lives and our world. In the meantime, however, pre-emptive regulation by the FDA, the agency with the regulatory system most suited to handle these new devices, would be a prudent course of action. Encouragingly, most of the FDA's existing regulatory tools can be adapted for this task. Though legislative intervention might be needed to implement some of the details of the proposed Class IV and Class IV-E designations, many of the adjustments that would ensure safety and effectiveness, such as more rigorous enforcement of the FDA's postmarket authorities, as well as the Enhancement Panel approach, should be initiated by the agency alone. To summarize, a competent default regime, such as the one proposed here, would serve multiple functions. First, it would respond to the heightened, long-term safety & effectiveness risks presented by neuroelectronic devices in general, and user enhancement devices in particular. Second, it would help assure the public at large that something is being done about these new, challenging technologies. But perhaps more important than the damage control role that such a regime might play is the role in which a FDA regime would play in raising awareness about neuroelectronic user devices and guiding their development. It will have the ability to foster a substantive discussion of the problems associated with enhancement, while simultaneously allowing the underlying technologies time to develop.