What should be included in an abbreviated 510(k) submission?

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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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About the Author
Proxima CRO Team
Dora Huang
Intern

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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