What should be included in documentation for device changes?

• 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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