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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key biocompatibility requirements for 510(k) implant devices?
FDA recommends following ISO 10993-1 framework with minimum endpoints including cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. Additional endpoints like genotoxicity, implantation, and chronic toxicity may be required based on device contact nature.
When is clinical data required for 510(k) implant submissions?
Clinical data may be necessary when non-clinical testing alone cannot demonstrate substantial equivalence, particularly for devices with different technological characteristics that raise safety/effectiveness questions. The need depends on device type, predicate differences, and benefit-risk assessment requirements.
What cybersecurity considerations apply to implantable medical devices?
Implants with software must address cybersecurity risks throughout the total product lifecycle. FDA recommends following guidance on premarket cybersecurity submissions and postmarket management, considering risks that might necessitate implant removal and designing with sufficient memory for security updates.
How should manufacturers address MR compatibility for implant devices?
All implants have MR environment risks including displacement forces, heating, vibrations, device malfunctions, and image artifacts. FDA recommends following MR safety testing guidance and providing appropriate labeling with MR conditional information and safety icons per ASTM F2503 standards.
What patient information should be provided with implant devices?
FDA recommends implant ID cards containing device identifying information, composition details, adverse event reporting instructions, and MR safety conditions. This information should be easily conveyed to patients to ensure safe use throughout the implant’s expected lifespan.
What animal testing considerations apply to 510(k) implant evaluations?
Animal testing may be recommended for implants that degrade/wear, have unclear migration patterns, require histological safety evaluation, involve complex procedures, or assess functional outcomes. FDA encourages following 3Rs principles (replace, reduce, refine) and using Q-Submission Program for study design feedback.
What You Need to Do 👇
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