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.
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 summary file ID: 81cf8c26b544575af458109dc804dd67
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