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My company has a software solution that is subject to FDA
approval/scrutiny. That entity insists that we use the following cautionary
statement in our user manual:
CAUTION: Federal law restricts this device to the sale by, or on the order
of, a physician.
Because the software is not a device, I modified the statement to read:
CAUTION: Federal law restricts this product to the sale by, or on the order
of, a physician.
Now our regulatory affairs guy has a pickle up his _____ and is hassling me
over the change. I believe that no one can, or will, bother us about this
minor modification.
What are your thoughts about this?
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