The U.S. FDA has announced a significant step to promote the development of a new generation of implantable devices that can be more fully integrated with a patient’s brain. Known as brain-computer interface (BCI) devices, the implantable devices hold the potential for direct control of a limb prosthesis via a patient’s thought processes. This can allow significantly greater mobility and independence for patients.
The devices have the potential to benefit people with severe disabilities by increasing their ability to interact with their environment. This is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility and the FDA has issued its draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including the nation’s veterans.
“This achievement is the result of our broader work to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review,” notes FDA commissioner Scott Gottlieb, MD. “We’re committed to providing the right tools and fostering an environment that lets the developers of novel technologies advance innovative ideas, while prioritizing patient safety, and delivering on our public health mission.”
He adds: “The draft guidance is considered a ‘leap-frog guidance because it helps bridge where we are today with innovations of tomorrow, providing our initial thoughts about regulatory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. 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.”
Among other steps, the agency has committed to searching the landscape for future innovations with the development of the Emerging Sciences Working Group, a team of 15 FDA experts representing various specialties and FDA centers. The group is charged with leveraging scientific expertise and resources to conduct long-range horizon scanning, and advising agency and FDA Center leadership on how emerging issues and cross-cutting scientific advances may affect the FDA’s preparedness and activities across government agencies, including asking for public input on advances that aren’t even on most people’s radars.
The FDA is also committed to collaborating with stakeholders, including product developers, across the health care ecosystem on specific areas that we know are advancing and ripe for disruption.
As Gottlieb explains, the organization will often pull together stakeholders to discuss promising areas for development. For example, they recently held an event to discuss the development of Orthopaedic SMART devices. The workshop was intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART devices. Public input and feedback gained through this workshop may aid in the efficient development of innovative, safe and effective Orthopaedic SMART devices for better patient care.
“The workshop has resulted in a common understanding of the current stage of development for this promising technology and the possibilities for advancing patient care,” Gottlieb says.
He adds that the FDA identifies these areas in numerous ways. “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,” Gottlieb says. “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.”
