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What should be included in an abbreviated 510(k) submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The following content should be included in an abbreviated 510(k) submission:

  • Cover sheet identifying the submission as an “Abbreviated 510(k)”
  • Information required under 21 CFR 807.87, including:
    -    Description of device
    -    Intended use and indications for use
    -    Proposed labeling
  • Summary report that describes guidance, including:
    -    How the guidance was used to demonstrate substantial equivalence
    -    How the device complies with special controls
    -    Device description
    -    Manufacturer’s device design requirements
    -    Risk management
    -    Test methods
  • Voluntary Consensus Standards (if needed)
  • Data and information to address issues not covered by guidance documents, special controls, and/or voluntary consensus standards
  • Indications for Use form (FDA Form 3881)

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