Comment 25) One comment objects to FDA's reliance on JRC's coverage doc listing possible collateral outcomes of ESDs mainly because this document was designed in response to a need from the NYSED by way of Corrective Action Requests to contain a dialogue of the collateral results of aversive interventions in its insurance policies, and there is no evidence ESDs prompted any of these collateral effects. Specifically, NYSED gained experiences of AEs, which NYSED refers to as collateral consequences, from the use of these gadgets, such as increases in aggression and boosts in escape behaviors or psychological reactions. However, the scientific studies done for acceptance of the medication offer a much better baseline to understand their pitfalls than that readily available for ESDs, and the experiments health supplement our understanding from spontaneous postmarket experiences of AEs. Dr. McCracken testified that in the literature about the use of ESDs, "there has been virtually no attempt to identify or analyze side effects" (Ref. Fda disagrees. As talked about in the proposed rule, Fda thinks that the scientific literature suffers from various constraints and has possible underreported AEs affiliated with ESDs for a amount of reasons (see eighty one FR 24386 at 24935). Perhaps most importantly, the devices have been examined only on a incredibly little variety of subjects, many of whom would have trouble communicating or in any other case demonstrating AEs, together with injuries

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