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# FDA Bans Some Electrical Stimulation Devices
- URL: https://www.fdaweb.com/fda-bans-some-electrical-stimulation-devices/
- Published: 2020-03-04T12:00:00.000Z
- Updated: 2026-09-14T16:05:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146236

FDA has published a final rule to ban electrical stimulation devices used for self-injurious or aggressive behavior. An agency [media statement](https://www.fda.gov/news-events/press-announcements/fda-takes-rare-step-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior?ref=fdaweb.com) says the devices “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.”

The devices administer electrical shocks through electrodes attached to the skin of individuals to immediately interrupt self-injurious or aggressive behavior or attempt to condition the individuals to stop engaging in such behavior. FDA says evidence indicates that a number of significant psychological and physical risks are associated with the use of the devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns, and tissue damage.

“Evidence of the device’s effectiveness is weak and evidence supporting the benefit/risk profiles of alternatives is strong,” the agency statement says.

The [final rule](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-04328.pdf?ref=fdaweb.com) is said to contain only minor changes from a 4/25/16 proposed rule, including clarification of which devices are banned and an explanation that the ban is not a special control that allows the continued use of the device. The rule applies only to devices used for self-injurious or aggressive behavior and does not apply to aversive conditioning devices used for other purposes, such as those used for smoking cessation, which are outside the scope of the rule, or other FDA cleared or approved devices or technologies such as cranial electrotherapy stimulators or transcranial magnetic stimulation, both of which have been found to have a reasonable assurance of safety and effectiveness for different indications.