The Role of FDA in the BCI Journey

The Role of FDA in the BCI Journey

The Role of FDA in the BCI Journey

July 8, 2024

The recent launch of the Implantable Brain Computer Interface Collaborative Community (iBCI-CC) marks an important landmark in the growth of the industry. Five major US Brain Computer Interface (BCI) companies have joined ALS and spinal cord injury patient advocacy groups, leading academic ethicists and researchers, and, most importantly, regulators from the Food and Drug Administration and Commerce Department. The spirit at these meetings is energized and collaborative, infused with a sense of common purpose. The field was not always this way.

Implantable BCI Collaborative Community

The Role of FDA in the BCI Journey

The first demonstrations of computer control by a person using an implanted brain computer interface occurred in the early 2000’s - a challenging time for innovative device companies developing implantable BCI technology due to the nascent regulatory pathway and lack of predicate technologies. In 2010, Josh Makower, MD of Stanford Medicine, and several colleagues in the academic and the private sector wrote an influential report entitled “FDA Impact on U.S. Medical Technology Innovation.” After analyzing survey results from the over 200 medical device companies polled, they concluded: “Unpredictable, inefficient, and expensive regulatory processes are jeopardizing America’s leadership position in medtech innovation.”

The FDA was listening. The first initiative by the FDA to remedy this was implementation of the EFS (Early Feasibility Study) Program, to help provide US patients first access to novel technologies and deter manufacturers from conducting trials outside of the United States, where the clinical trial requirements were less stringent. This program enabled the initiation of clinical trials with the intent to mitigate any potential safety risk or uncertainties associated with novel technologies.

Over the next decade, the Agency created a new Breakthrough Device Program to propel innovative devices within the existing regulatory process with the goal of helping patients have more timely access to medical devices. More recently the FDA created the TAP Program, in which the FDA further accelerates  collaboration with companies, therefore promoting even faster approval of such devices.

In addition to this momentum pertaining to innovative medical devices in general, the FDA proactively released a specific BCI guidance document in 2021 for implantable BCI devices in response to the development efforts and clinical progress, in which the Agency acknowledged:

“The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life.”

Although the FDA’s engagement has bolstered the progress of the BCI industry, something equally important has occurred. Scientists and engineers with experience in BCI technology have begun to hear their calling in the regulatory sciences.

“Many of us in the scientific community felt that the place where we could best effect bringing therapies to patients would be in the field of regulatory science” said Devjani Saha, PhD, Director, Neurology Regulatory Affairs at MCRA.

As a result of these policy changes and an influx of passionate young scientists, the FDA is not the same FDA agency it was two decades ago. Many within the FDA Office of Neurological and Physical Medicine Devices have backgrounds in BCI. David McMullen, MD, Director, Office of Neurological and Physical Medicine Devices (OHT5, CDRH, FDA), is a neurosurgeon with experience both as a BCI researcher and as a proponent of BCI research during his tenure at the National Institute of Health. In a recent Medtech Insight article, he described the TAP Program as “almost breakthrough on steroids. It provides even more frequent interaction with the FDA, but also brings in all the other stakeholders in the ecosystem, because we understand that just because you get an FDA stamp of approval unfortunately doesn’t mean patients can have access the next day.”

There is a lot of work still ahead for the BCI community. While Synchron is exiting a successful early feasibility study and now launching a pivotal trial, another better known member, Elon Musk’s Neuralink, recently reported a mechanical failure of its device in its first patient. The community and industry at large will need to navigate many more failures and successes as the industry sees a massive influx of venture capital and a growing number of clinical trials, but investors are hopeful.

“This BCI industry has gone from 0-60 in the last few years” says Paradromics investor and Board Member, Amy Kruse, “and now that the FDA is signaling its willingness to lean in and accelerate innovation, investment in the space will only heat up.”

Ultimately, greater regulatory clarity, increased collaboration, and additional investment will mean better patient outcomes, sooner. 

Learn more about the iBCI Collaborative Community in iBCI-CC: Empowering Through Collaboration.