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This helps make crystal clear, for example, that a medical professional may prescribe an permitted product for a use diverse from those people for which it has been approved it does not, even so, in any way limit FDA's potential to figure out which units can be lawfully promoted and the works by using for which they can be lawfully promoted. Third, if the commenter's place is that Fda should not prohibit use of a gadget that may well be unsafe if labeling can sufficiently mitigate this sort of hurt, the hazardous works by using of ESDs are its labeled takes advantage of, not ones outside the house the labeling, which are the goal of part 513(i)(1)(E). Further, portion 516 of the FD&C Act and its implementing restrictions only authorize banning wherever Fda has identified the deception or possibility are unable to be corrected or removed by labeling, as Fda has performed here this is also consistent with the ideas fundamental area 513(i)(1)(E) of the FD&C Act. Because these variables are outside the house of the user's manage or are tough to verify or predict, labeling that corrects or removes the threats of ESDs for SIB or AB cannot be created. Regardless of how the unit is labeled, the unique subject matter to it will receive shocks intended to be distressing and will carry on to be subject to the bodily and psychological pitfalls we have explained in this rulemaking
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