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What information should be included in the 510(k) Cover Letter, 510(k) Summary, and 510(k) Statement?
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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 510(k) cover letter should include information such as…

  • Type of 510(k) submission
  • Device type in plain terms
  • 510(k) submitter name
  • Contact information
  • Recommended classification
  • Device class
  • Review panel
  • FDA product code
  • Preference for confidentiality

The 510(k) summary is similar, in that it is a brief summary of the device and the supporting information, while the 510(k) statement is a certification that the 510(k) holder will provide a copy of the submission to any FDA personnel within 30 days of a written request.

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