FWIW, here’s my take on labeling
The label tells the user the very specific use of the product that the FDA has approved. All other uses are considered “off label”. FDA governs medical devices much the same way they govern medication. Take a look at the small print that comes with your next prescription and you will get an idea of complex a label can be. Although there may be other valid uses for the product, the Label can not describe them unless they have been fully proven and authorized by the FDA.
An example might be found in the history of Botox. In 1989, it was originally FDA approved as safe and effective for relaxing the muscles that caused crossed eyes and eye muscle spasms. Although physicians were using it for removing frown lines etc., it had not yet been approved for that purpose by the FDA and therefore could not be labeled as such. Physicians using Botox to enhance patient’s looks were said to be using it “off label”. Sometime in 2002, after proving its effectivity and safety etc., it was approved for removing frown lines and the “Label” then was amended to reflect that use.
If you had bought some Botox a week before the FDA expanded its newly labeled use you could then use it for that new application also. Similarly, if you owned a DVIS prior to a labeled application change, you could then use it for the new application.
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