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This makes distinct, for case in point, that a physician may well prescribe an authorized system for a use different from individuals for which it has been authorised it does not, however, in any way limit FDA's skill to ascertain which units can be legally marketed and the takes advantage of for which they can be legally marketed. Third, if the commenter's stage is that Fda should not prohibit use of a gadget that may be damaging if labeling can adequately mitigate such damage, the hazardous utilizes of ESDs are its labeled employs, not ones outside the house the labeling, which are the goal of segment 513(i)(1)(E). Further, segment 516 of the FD&C Act and its utilizing restrictions only authorize banning in which Fda has identified the deception or hazard can't be corrected or eradicated by labeling, as Fda has finished here this is also steady with the concepts fundamental portion 513(i)(1)(E) of the FD&C Act. Because these components are outside the house of the user's manage or are complicated to verify or predict, labeling that corrects or eliminates the pitfalls of ESDs for SIB or AB simply cannot be composed. Regardless of how the machine is labeled, the specific subject to it will obtain shocks intended to be painful and will continue to be matter to the actual physical and psychological pitfalls we have described in this rulemaking

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