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What should be included in documentation for device changes?
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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.

  • 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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