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Alternatives to over-labeling

  • 1.  Alternatives to over-labeling

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2019 16:50
    This message was posted by a user wishing to remain anonymous

    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?