The FDA is hoping to help the industry take a leap toward what was once pure science fiction: interfaces that link brains and computers, allowing a person to directly control devices with their thoughts.
To promote development of a new generation of fully integrated implants, the agency published a new draft guidance (PDF) that provides the FDA’s initial regulatory considerations as the technology progresses.
The eventual goal is to develop a framework for improving the mobility and independence of patients with paralysis or amputations, including injured veterans, through controllable prostheses.
In addition, the FDA launched a cross-center working group of 15 internal experts representing different scientific specialties, who will advise the agency on emerging technologies and the FDA’s ability to keep pace in its regulations.
“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,” Commissioner Scott Gottlieb, M.D., said in an agency statement. “We know innovation is often capital intensive and risky and we understand that we can help reduce the risk and cost of capital to advance these patient opportunities by giving clear direction early in the development process.”
The draft guidance provides recommendations and technical advice for product developers on how to design clinical and nonclinical tests for implanted brain-interface devices, and how nonclinical device testing can demonstrate the mitigation of risks before the launch of a clinical study.
It also details considerations for the long-term biocompatibility with blood, cerebrospinal fluid and nerve tissue, as well as electrical and electromagnetic safety standards, including wireless technology and compatibility with MRI machines.
“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,” said Gottlieb.