A researcher instructs a patient on how to move an artificial hand using a brain/computer interface implant.
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.
FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. It also provides detailed recommendations on preparing to submit an application for an investigational device exemption.
Having clear direction early in the process may help device developers in this rapidly evolving field save money and reduce risk, according to FDA Commissioner Dr. Scott Gottlieb.
“The draft guidance is considered a ‘leap-frog’ guidance because it helps bridge where we are today with innovations of tomorrow, providing our initial thoughts about regulatory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,” Gottlieb said in a prepared statement. “Our success in improving safety and driving innovation depends, in part, on our ability to quickly identify the potential for future technological breakthroughs that can alter the paradigm for how we approach certain medical challenges and advance these goals.”
In addition to issuing the draft guidance, FDA has formed an “emerging sciences working group” of 15 agency experts to seek out and advise the agency of emerging issues and scientific advances. FDA will also work with product developers and other stakeholders in specific areas that “we know are advancing and ripe for disruption,” Gottlieb said.
Examples of these devices are being developed worldwide. A Swedish woman with a hand amputation recently became the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis. In 2017, an international research team developed a BCI that can read brain chemistry to enable communication in patients who are paralyzed and unable to talk. FDA has put a particular focus on helping paralyzed military veterans and those who have amputations to regain physical function.
“There are many ways we identify these areas,” Gottlieb said. “Once we do, we work to ensure that the tools are in place to advance the development of these new technologies, by providing clarity and direction to medical device developers to help reduce the barriers of bringing new treatments to patients.”
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