The U.S. Food and Drug Administration (FDA) announced a draft guidance to promote the development of a new generation of brain-computer interface (BCI) devices, including those that provide direct control of prosthetic limbs, while prioritizing patient safety. The FDA says the draft guidance is “leap-frog” guidance because it will help address future innovations and provide “initial thoughts about regulatory considerations for an emerging health technology with the understanding that our recommendations are likely to evolve as the FDA works to finalize the guidance to account for public comments, technological developments and new information,” said FDA Commissioner Scott Gottlieb, MD.
The FDA also established the Emerging Sciences Working Group of 15 FDA experts representing various specialties to advise the agency how emerging issues and scientific advances may affect government agencies’ preparedness .
“The FDA is also committed to collaborating with stakeholders, including product developers, across the healthcare ecosystem on specific areas that we know are advancing and ripe for disruption,” said Gottlieb. “We’ve also seen meaningful advances in neurology, and the FDA has helped advance research into biomarkers to detect early signs of traumatic brain injury and the development of patient-centric assessment methods for upper-limb prostheses. The idea that a prosthetic could interact with the brain has been the topic of much imagination, but now we’re actually on the verge of realizing this opportunity. The FDA has an important role to play by laying out a path for developers on how to seize this prospect and advance the development of new devices.”
The draft guidance provides proposed recommendations for developers on what non-clinical testing and clinical study design could be used to develop BCI devices for patients with paralysis or amputation. This includes detailed technical advice and recommendations for study designs to support safety and effectiveness. The draft proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated prior to initiating a clinical study.