FDA Renews Proposal to Ban Electrical Stimulation Devices for Behavioral Control

The FDA has renewed its proposed ban on electrical stimulation devices used to reduce or stop self-injurious or aggressive behavior, citing the devices' unreasonable and substantial risk of illness or injury. The ban would apply specifically to devices intended for self-injurious or aggressive behavior, with the FDA emphasizing alternative approaches such as positive behavioral support and medications. The proposal will be open for public comment until May 28, after which the FDA will review and consider comments before making a final decision.