An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality. FDA recently released a draft guidance document that provides recommendations on how to gain approval to conduct clinical studies of these devices in support of eventual marketing clearance. The new draft guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations (Guidance), provides recommendations for non-clinical testing and clinical study design information that should be included in pre-submissions or Investigational Device Exemptions (IDE) for BCI devices, which are defined as “neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation.” Guidance at 1. Designated a “leapfrog guidance,” it serves as a “mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.” Id. at 2.
Though the scope of the guidance is limited to pre-submissions and IDEs for implanted BCI devices, the presentation of information is likely to be a useful reference for other devices and submission types. The guidance provides detailed recommendations on descriptive information to be provided for the system and its key components, many of which are used in other device types, including leads, electrodes, connectors, processing hardware, stimulation hardware, assistive components, programmers, control units, algorithms, and batteries. The guidance then walks through the types of information and testing that should be included in an IDE application, including software, biocompatibility, sterility, pyrogenicity, shelf life and packaging, electrical safety and electromagnetic compatibility, wireless technology, magnetic resonance (MR) compatibility, non-clinical bench testing, animal testing and clinical performance testing. Throughout these sections, reference is given to many existing topic-specific FDA guidance documents and FDA recognized standards.
As is to be expected for an implanted device, FDA emphasizes the need to demonstrate the safety and reliability of implanted BCI devices. While much work is needed to bring an implantable BCI device to clinical trials, they are clearly emerging from the realm of science fiction, which is great news for patients with paralysis or amputation who would be the ultimate beneficiaries.