FREQUENTLY Asked Questions
What should be included in documentation for device changes?
View All FAQs
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)

Related Terms:
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST