Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
This guidance provides recommendations for Q-Submissions and Investigational Device Exemptions (IDEs) for implanted Brain-Computer Interface (BCI) devices intended for patients with paralysis or amputation. It focuses on devices that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities. The guidance covers non-clinical testing and clinical study design considerations.
What You Need to Know? 👇
What documentation level is required for implanted Brain-Computer Interface (BCI) devices under FDA’s current software guidance?
Implanted BCI devices should generally address recommendations for an Enhanced Documentation Level under FDA’s 2023 guidance “Content of Premarket Submissions for Device Software Functions,” which superseded the previous 2005 guidance that classified BCI devices as Major Level of Concern.
What are the key biocompatibility testing categories for implanted BCI device components?
Four main categories apply: Category 1 for permanent neural/CSF contact (requiring cytotoxicity, sensitization, implantation, neurotoxicity, hemocompatibility, chronic toxicity, and carcinogenicity testing), Category 2 for permanent tissue contact, Category 3 for limited tissue contact, and Category 4 for skin contact devices.
What animal study duration is recommended for implanted BCI device safety evaluation?
A long-term follow-up period of at least 1 year is recommended due to limited data on long-term effectiveness of implanted electrodes and to identify potential long-term safety signals that may not be apparent in shorter studies.
What are the essential inclusion criteria for BCI clinical study participants?
Key criteria include appropriate age range, specific spinal injury levels, defined clinical conditions and paralysis levels, ability to understand informed consent, verbal or typing communication capability, ability to follow postoperative management, and availability of willing caregivers for daily monitoring.
What wireless technology testing standards apply to implanted BCI devices?
BCI devices with wireless functionality should be assessed using AAMI TIR69 for risk management of RF wireless coexistence, and ANSI/IEEE C63.27 for environmental specifications when wireless function is critical to clinical performance.
What are the mandatory non-clinical bench tests for BCI electrodes?
Essential tests include dimensional verification and visual inspection, impedance measurements with specified tolerances based on intended use, and accelerated lifetime testing using aging protocols in simulated physiological environments to assess long-term device functionality and integrity.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive risk management plan following ISO 14971
- Plan and conduct appropriate non-clinical testing including bench and animal studies
- Develop human factors and usability engineering plan
- Establish software development and validation processes
- Develop biocompatibility evaluation strategy
- Plan sterility validation approach
- Establish electrical safety and EMC testing plan
- Develop clinical study protocol with appropriate endpoints
- Consider patient input and preferences in device development
- Prepare documentation for Q-Submission/IDE following guidance recommendations
- Engage with FDA early through Q-Submission process for feedback
- Establish system level testing plan for multi-component systems
- Develop home use validation strategy if applicable
Key Considerations
Clinical testing
- Long-term follow up period of at least 1 year recommended
- Need to study devices in realistic home use environments
- Need to assess caregiver safety and ability to assist users
- Clear inclusion/exclusion criteria essential to define appropriate patient population
- Need to characterize all adverse events
- Patient input and preferences should be considered
- Need for validated clinical endpoints (except for feasibility studies)
Non-clinical testing
- Animal testing recommended to evaluate in vivo safety, particularly for new designs
- Study duration dependent on device risk profile
- Need for histopathological evaluation of implanted tissue
- Need to establish long-term device performance in biological environment
- Need for acute and long-term stimulation testing if applicable
Human Factors
- Need to understand specific behaviors required of users
- Need to consider environment of use
- Need to evaluate intended users characteristics
- Need to incorporate use-related hazards into risk management
- Need for usability evaluations throughout development
Software
- Major level of concern for software documentation
- Need for full software description and testing
- Need to address cybersecurity aspects
- Need to document off-the-shelf software use if applicable
Cybersecurity
- Need to assess cybersecurity risks
- Need to provide information on cybersecurity aspects
- Need to follow FDA guidance on cybersecurity management
Biocompatibility
- Need to determine biocompatibility of all patient-contacting materials
- Different testing requirements based on contact type/duration
- Need for biocompatibility risk assessment if no predicate device
- Need to address bacterial endotoxins and material-mediated pyrogens
Safety
- Need for electrical safety testing
- Need for electromagnetic compatibility testing
- Need for wireless technology safety assessment if applicable
- Need for MR compatibility assessment
- Need to assess stimulation safety parameters
Other considerations
- Need for sterility validation
- Need for shelf life and packaging validation
- Need for risk management following ISO 14971
- Need for system level testing for multi-component systems
Relevant Guidances 🔗
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations for Medical Devices Intended for Home Use
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- ISO 14971: Medical devices – Application of risk management to medical devices
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ISO 14708-3: Implants for surgery – Active implantable medical devices - Part 3: Implantable neurostimulators
- AAMI TIR69: Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
Original guidance
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- HTML / PDF
- Issue date: 2021-05-20
- Last changed date: 2021-05-19
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket, Neurological
- ReguVirta ID: 81cf8c26b544575af458109dc804dd67