Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations.
CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patients with paralysis or amputation. It is intended to “leapfrog” into the BCI space with initial regulatory clarifications on FDA expectations for submissions, pending changes driven by technological advances.
An overarching recommendation relates to early feasibility studies
to advance final versions of implanted BCI devices under development, citing a lack of available nonclinical testing methods for BCI.
BCI devices are defined as computer technology designed to interact with neural structures for decoding and translating information derived from the user’s thoughts into actions. The draft guidance’s scope is limited to devices that restore motor and/or sensory capabilities in patients with paralysis or amputation.
The draft guidance describes recommendations regarding IDE applications and pre-submissions, which fall under the larger mechanism for interactions with CDRH staff early in the product development phase and marketing submission process that is now known as the Q-submission program. These range from device description, software functions and biocompatibility to shelf life and packaging, as well as wireless technology and magnetic resonance compatibility. The nonclinical bench testing section offers its own subset of recommendations, including on risk analysis, electrodes, leads and connectors. It recommends using methods in the global standard ISO 147008-3 for output stimulation measurements.
A rapidly emerging trend is highlighted under the endpoints section. This relates to the growing use of patient preference information (PPI). PPI “may be an important factor in the design and benefit-risk evaluation of a medical device, including implanted BCI devices,” CDRH said. “Ideally, a BCI technology should be comfortable, easy to don and doff (i.e. put on and take off, if applicable), user friendly, reliable and aesthetically neutral or appealing, so patients are willing to accept and use the device.”
Additional draft recommendations relate to referencing master files and other FDA premarket submission types, animal testing, clinical performance testing and output stimulation characteristics.
Options are currently limited for patients with paralysis or amputation, though industry has achieved advancements in the areas of prostheses such as in robotics. BCI devices, particularly those that fall within the scope of the new draft guidance, have yet to proliferate the US market. With its 2018 launch of the Next Gen RNS System
, NeuroPace touted
the device as the world’s only BCI for the treatment of refractory epilepsy.
In reaction to the draft guidance, FDA Commissioner Scott Gottlieb said
on Friday that “this is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility.”
The draft guidance draws from a public workshop
FDA held in 2014 to facilitate an open discussion on scientific and clinical considerations for the development of BCI devices. Leapfrog guidances such as this one help clarify the agency’s initial thoughts on emerging technologies deemed likely to be important to public health earlier in product development.
In a 2016 article
published in the Journal of Neural Engineering
, CDRH officials along with other federal government officials and industry stakeholders summarized the discussions from the 2014 public workshop on BCI devices. The authors noted CDRH “believes it is important to help stakeholders navigate the regulatory landscape for medical devices.” They added that “for innovative devices involving brain–computer interfaces, this is particularly important.”
CDRH Director Jeff Shuren previously indicated leapfrog guidances is an area that will be coming under the spotlight more and more frequently as the center works to keep pace with emerging technologies.
“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 Friday. "This is the fourth leap-frog guidance we’ve issued for public comment and we have seen firsthand the impact they can have on realizing the potential of innovative technologies."