FDA Moves to Ban Shock Devices Used in Psychiatry

The U.S. Food and Drug Administration (FDA) has issued a proposal to ban electrical stimulation devices (ESDs) used to deter self-injurious or aggressive behavior, citing an unreasonable risk of illness or injury. These devices deliver electric shocks to the skin and have been subject to scrutiny due to concerns about their safety and efficacy. The FDA's latest action represents a renewed effort following a previous attempt to ban the devices in 2020, which was invalidated by a federal court ruling.

The only facility in the United States known to currently employ these devices is the Judge Rotenberg Education Center in Canton, Massachusetts. The FDA's proposed rule seeks to remove ESDs from the market, asserting that the risks associated with their use cannot be mitigated by revised labeling or other measures.

The agency is now inviting public commentary on the proposal until May 28, 2024, after which it will review the feedback before making a decision on the final rule. This action falls under the FDA's authority as granted by the Federal Food, Drug, and Cosmetic Act, which empowers the agency to regulate medical devices and ensure their safety for public use.