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How do you label a medical device that has been upgraded in the field to a new version of the product with a different part number? Over-label the device with a new label containing the new part number and other labeling information is one way to go. However, over-labeling is
discouraged by FDA and some foreign countries. What other options/alternatives other than over-labeling? What if the said device is upgrade once more and is there a limit to over-labeling?