FDA Drafts Brain-Computer Device Regulatory Guidance

(HypnoArt, Pixabay)

25 Feb. 2019. Food and Drug Administration is releasing for comment regulatory guidance for its review of implanted medical devices that connect human brains to computer systems. The draft guidance document is expected to be posted today on the U.S. government’s regulations portal, Regulations.gov.

The document provides the agency’s current thinking on regulating implants with brain-computer connections for treating people with severe disabilities from conditions such as spinal cord injuries, and stroke or neuromuscular disorders, where individuals lose all or most ability to move their limbs. Spinal cord injuries are often caused by a sudden, traumatic blow to the spine that bruises or tears into spinal cord tissue, resulting in fractures or compression to vertebrae, or in some cases severing the spinal cord. According to the National Spinal Cord Injury Statistical Center, spinal cord injuries occur in 54 out of 1 million people in the U.S., adding some 17,500 new cases each year.

Brain-computer connections are found in devices with electrodes implanted in the brain to capture electrical signals with, for example, mental commands to direct or control prosthetic limbs, sometimes with robotic mechanisms. Among individuals who could benefit from these systems are returning war veterans, many of whom return with severe disabilities, including amputations from improvised explosive devices as well as paralysis.

The regulatory guidance outlines requirements to follow for developers of medical devices in testing brain-computer interfaces and documenting the results. Preclinical testing, says FDA, should be designed to lower risks to humans in later clinical trials. The document recommends that developers first identify all potential hazards and points of failure, with tests in electronic simulations and labs designed to ensure that failure of any components do not result in unacceptable risks to patients. Animal testing can be considered, but only where no other testing methods are feasible, including computational modeling.

For clinical trials, FDA largely refers to other agency documents on conducting tests of medical devices with human subjects. However, the guidance calls for attention to special needs of the patient population, as well as considering use of in-home tests rather than requiring travel to clinic. In addition, the document recommends measures or end-points for clinical trials beginning with safety to capture all adverse effects, primary and secondary effectiveness measures, and feedback from study participants on the devices.

In a statement on Friday, FDA Commissioner Scott Gottlieb noted that the agency calls the document “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 adds that the agency started a related Emerging Sciences Working Group with 15 experts from different parts of FDA. The group plans to advise the agency on long-range developments in science and technology affecting the agency’s mission. FDA is also holding workshops with scientific and industry stakeholders to learn about technical and regulatory challenges in new medical technologies. An example is a workshop held in April 2018 on Orthopedic Sensing, Measuring, and Advanced Reporting Technology, or SMART, devices.

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