The FDA Bans Electrical Stimulation Devices

Today, the U.S. Food and Drug Administration (FDA) issued a final rule banning electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.

These devices are associated with an extensive list of potentially serious psychological harms and physical risks, including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder (PTSD), pain, burns, and tissue damage. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult for them to communicate their pain or make their own treatment decisions. As these risks cannot be corrected or eliminated by labeling or a change in labeling, banning the product is necessary to protect public health.

Read the Final Ban

The act of banning a device is rare, but the FDA takes this action when necessary to protect the health of the public. For more information, please see the FDA’s Medical Device Ban webpage.