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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This is a draft guidance. Not for implementation.

  1. Conduct comprehensive risk analysis considering total product lifecycle
  2. Develop testing plan addressing:
    • Biocompatibility
    • Performance testing
    • Human factors
    • Software/cybersecurity if applicable
    • Sterilization validation
  3. Prepare detailed documentation on:
    • Device design and materials
    • Manufacturing processes
    • Test results and analyses
    • Risk management file
  4. Create comprehensive labeling including:
    • Instructions for use
    • Patient information
    • Implant card
    • MRI safety information
  5. Consider pre-submission meeting with FDA to discuss:
    • Testing strategy
    • Data requirements
    • Specific concerns for novel features
  6. Implement post-market surveillance plan to monitor long-term performance and safety
  7. 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

  • 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

  • Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k
  • HTML / PDF
  • Issue date: 2023-09-07
  • Last changed date: 2023-09-06
  • Status: DRAFT
  • Official FDA topics: Medical Devices, 510(k), Premarket, Biologics
  • ReguVirta summary file ID: a87332eaf55135a020300f2e13b5ba91
This post is licensed under CC BY 4.0 by the author.