What should be included in documentation for device changes?

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  • Product name
  • Date of change assessment
  • Description of the device
  • Description of the change(s)
  • Reason why the change(s) is being made
  • Applicable regulatory history, including the 510(k) number of the most recently cleared version of the device
  • Comparison of the modified device to the most recently cleared version of the device (consider including a table)
  • Applicable elements of this guidance, including the applicable questions from the body of the document
  • Analysis and assessment of the elements on this list and a conclusion of whether submission of a new 510(k) is required
  • Reference to related documents, particularly those that support the decision whether or not submission of a new 510(k) is required (e.g., risk analysis)
  • Signature(s)

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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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