What information should be included in the 510(k) Cover Letter, 510(k) Summary, and 510(k) Statement?

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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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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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