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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
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.
  • 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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