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The Food and Drug Administration has issued a final rule banning electrical stimulation devices for self-injurious or aggressive behavior following a determination that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The ban includes both new devices (effective from April 6) and devices currently in use and subject to a physician-directed transition plan (effective from Sept. 2).
ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person’s skin to reduce or cease self-injurious behavior or aggressive behavior, which frequently manifest in the same individual. People with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates. ESDs intended for other purposes, such as smoking cessation, are not subject to this ban.
September 24, 2020 // Trade Report
September 23, 2020 // Trade Report