The FDA has banned electrical stimulation devices sometimes used to treat self-harm and aggression in people with intellectual or developmental disabilities.
The agency, which rarely bans medical devices, proposed the ban on the devices in 2016 because they present “an unreasonable and substantial risk of illness or injury to the public.” Some people’s intellectual or developmental disabilities make it difficult to communicate their pain or consent, the agency said. It said in November 2019 that the ban was imminent.