About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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