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The further references cited in the comments on the proposed rule go through from the similar methodological and other limits as people Fda deemed earlier, and the records and summaries JRC submitted pertaining to its inhabitants constitute an even weaker resource of evidence relating to the efficiency of ESDs for SIB or AB. Because the professional medical literature implies an underreporting of AEs, Fda very carefully evaluated challenges recognized via other sources, these types of as from authorities in the discipline, State businesses that regulate ESD use, and records from the only facility that is now utilizing ESDs for SIB or AB. We have divided the reviews and responses by subject make any difference, arranged like the proposed rule: track record information, proof interpretation, challenges of ESDs for SIB or AB, effects of ESDs on SIB or AB, point out-of-the-artwork for the therapy of SIB or AB, labeling and correcting or eliminating threats, lawful troubles, and eventually, changeover time. Although the out there details and facts demonstrate that some individuals subject to ESDs might show an instant interruption of the specific behavior, the out there evidence has not proven a sturdy conditioning effect or an in general-favorable benefit-hazard profile for ESDs for SIB or AB

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