Frequently Asked Questions

What should be included in a special 510(k) submission?

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The following elements should be included in a special 510(k) submission:

  • Cover sheet identifying a “Special 510(k): Device Modification”
  • Name of manufacturer’s legally marketed device and 510(k) number
  • Information required under 21 CFR 807.87, which includes:
    -    Detailed description of changes
    -    Comparison of modified device in tabular format
    -    Clean and redlined copies of documents that were updated from what was submitted in the predicate device’s submission
    -    Other changes to labeling or design
  • Voluntary Consensus Standards (if needed)
  • Summary report that describes guidance, which includes:
    -    Device description
    -    Manufacturer’s device design requirements
    -    Risk management
    -    Test methods
  • Based on risk analysis, an identification of verification/validation activities required to comply with 21 CFR 820.30, such as:
    -    Test methods
    -    Acceptance criteria
    -    Results (standardized vs non-standardized)
  • Indications for Use form (FDA Form 3881)
  • Signed statement that states predetermined acceptance criteria was met, and not in violation of design control procedure

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