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  • The intended uses of an article may change after it has been introduced???. [I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device???is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling ...for such other uses.21 C.F.R. ??801.4 (meaning of intended use) (medical devices) (emphas
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