(Reuters) – The U.S. Food and Drug Administration said on Monday it has proposed a ban of electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior.
The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
Electrical stimulation devices administer electrical shocks through electrodes attached to the skin to deter self-injurious or aggressive behavior.
The FDA has information to indicate that only one facility is currently using these devices in the United States, which is the Judge Rotenberg Education Center in Canton, Massachusetts.
The center did not immediately respond to a Reuters request for comment.
This is the second time the FDA has proposed a ban of these devices. Its first ban in 2020 was challenged in court and annulled, the agency said.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar)
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