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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
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 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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