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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