Industry Resources | March 20, 2020
FDA Rule: Banned Devices; Electrical Stimulation Devices For Self-Injurious Or Aggressive Behavior
On March 6, 2020, the Department of Health and Human Services finalized a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. The U.S. Food and Drug Administration determined ESDs present an unreasonable and substantial risk of injury or illness that cannot be corrected or eliminated by labeling . . .