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Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence

This guidance provides recommendations for industry and FDA staff about the content of 510(k) submissions and the decision-making process for determining substantial equivalence of medical devices reviewed under the 510(k) program. It covers key aspects like predicate devices selection, intended use determination, technological characteristics evaluation, and performance data requirements.

  1. Clearly identify appropriate predicate device(s) and document comparison
  2. Determine if intended use is the same as predicate device
  3. Compare technological characteristics with predicate device
  4. Determine appropriate testing requirements based on differences from predicate:
    • Non-clinical testing
    • Clinical testing if needed
    • Performance data requirements
  5. Prepare comprehensive 510(k) Summary following requirements
  6. Consider pre-submission meeting with FDA if guidance unclear
  7. Ensure compliance with applicable standards and regulations
  8. Document scientific rationale for use of reference devices if applicable
  9. Follow least burdensome approach while ensuring safety and effectiveness
  10. Maintain clear documentation of substantial equivalence justification

Key Considerations

Clinical testing

  • Clinical data may be needed when:
    • New/modified indications for use need validation
    • Technological differences require clinical validation
    • Non-clinical testing methods are limited/inappropriate
  • Less than 10% of 510(k)s require clinical data
  • Clinical data must constitute valid scientific evidence
  • Clinical studies must comply with IDE regulations as applicable

Non-clinical testing

  • Non-clinical bench performance testing includes:
    • Mechanical, electrical, biological engineering performance
    • EMC testing
    • Sterility testing
    • Stability/shelf life testing
    • Software validation
  • Must comply with GLP regulations as applicable
  • Should follow recognized consensus standards when available

Software

  • Software validation required based on level of concern
  • Documentation should follow FDA software guidance
  • Software changes affecting patient data analysis may require clinical validation

Labelling

  • Must include indications for use statement
  • Should be consistent with proposed labeling
  • 510(k) Summary must include detailed device description and labeling information

Biocompatibility

  • Testing should follow ISO 10993 standards
  • Must consider duration and type of tissue contact
  • Material specifications should be provided

Safety

  • Safety evaluation based on:
    • Technological characteristics comparison
    • Performance testing results
    • Risk analysis
    • Clinical data when needed

Other considerations

  • IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
  • IEC 60601-1-2: Medical electrical equipment - EMC requirements
  • ISO 10993: Biological evaluation of medical devices
  • ASTM F-67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications

Original guidance

  • Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
  • HTML / PDF
  • Issue date: 2014-07-28
  • Last changed date: 2019-03-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Administrative / Procedural, Premarket
  • ReguVirta summary file ID: c7ec2828b9175a0e295522ac53000923
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