Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior

On April 25, 2016, the U.S. Food & Drug Administration (FDA) released a proposal to ban electrical stimulation devices used to treat aggressive or self-injurious behavior of persons with autism and intellectual disability disorder. FDA has determined that these devices prevent an unreasonable and substantial risk of illness or injury to vulnerable persons with disabilities that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use . . .