Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
This guidance applies to medical devices that are placed into a surgically or naturally formed cavity of the human body and intended to remain implanted continuously for 30 days or more, requiring a 510(k) submission. While primarily focused on devices implanted for 30+ days, many recommendations also apply to shorter-term implants. The guidance excludes implants requiring premarket approval, those eligible for De Novo classification, and exempt implants.
This is a draft guidance. Not for implementation.
Recommended Actions
- Conduct comprehensive risk analysis considering total product lifecycle
- Develop testing plan addressing:
- Biocompatibility
- Performance testing
- Human factors
- Software/cybersecurity if applicable
- Sterilization validation
- Prepare detailed documentation on:
- Device design and materials
- Manufacturing processes
- Test results and analyses
- Risk management file
- Create comprehensive labeling including:
- Instructions for use
- Patient information
- Implant card
- MRI safety information
- Consider pre-submission meeting with FDA to discuss:
- Testing strategy
- Data requirements
- Specific concerns for novel features
- Implement post-market surveillance plan to monitor long-term performance and safety
- Maintain documentation of design controls and risk management throughout product lifecycle
Key Considerations
Clinical testing
- Clinical data may be needed when evaluating benefit-risk assessment for devices with different technological characteristics
- Patient experience data and patient-reported outcomes should be considered where relevant
- Patient preference information may be used to understand trade-offs between benefits and risks
Non-clinical testing
- Biocompatibility evaluation according to ISO 10993-1
- Sterility validation and pyrogenicity testing
- Shelf life testing for package integrity and device performance
- Material characterization and processing information
- Corrosion testing for metal implants
- Fatigue testing under simulated use conditions
- Degradation profile evaluation
- Particulate characterization for wear/degradation
- Coating characterization if applicable
Human Factors
- Conduct use-related risk analysis
- Apply human factors engineering processes focusing on user interface
- Evaluate critical tasks including surgical implantation
- Consider workflow between different user groups
- Validate training materials
Software
- Follow guidance for device software functions
- Consider long-term software maintenance needs
- Include sufficient memory for future security updates
Cybersecurity
- Address cybersecurity risks and controls
- Consider total product lifecycle approach
- Plan for End of Service/End of Life management
Labeling
- Include detailed instructions for use
- Provide patient information in accessible format
- Include implant ID card with device details
- Specify MRI safety information if applicable
- Include information on reporting adverse events
Biocompatibility
- Evaluate cytotoxicity, sensitization, irritation
- Consider acute and chronic toxicity
- Assess material-mediated pyrogenicity
- Evaluate genotoxicity and carcinogenicity if applicable
Safety
- Evaluate electrical safety if applicable
- Assess electromagnetic compatibility
- Test MRI compatibility
- Consider imaging and radiotherapy compatibility
- Evaluate risks during everyday activities
Other considerations
- Animal testing may be needed in some cases
- Consider design aspects like materials and manufacturing
- Evaluate shelf life and packaging
- Assess reprocessing/cleaning if applicable
Relevant Guidances
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Patient Preference Information in Medical Device Development, Clinical Trials, and Regulatory Decision Making
Related references and norms
- ISO 10993-1: Biological evaluation of medical devices
- IEC 60601-1-2: Medical electrical equipment - EMC requirements
- ISO 14708: Implants for surgery - Active implantable medical devices
- ASTM F1980: Accelerated aging of sterile barrier systems
- ANSI/AAMI/ISO 11607: Packaging for terminally sterilized medical devices
- ASTM F2503: Safety marking in the magnetic resonance environment
Original guidance
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