The QMN Weekly Bulletin
Quality / Medical Devices / Postmarket Safety

FDA Looks to Ban Electrical Stimulation Devices

June 10, 2016

The FDA is looking to ban electrical stimulation devices used to prevent self-injury and aggressive behavior.

“ESDs pose an unreasonable and substantial risk to public health that cannot be controlled or corrected from changes to labeling,” the FDA says in a proposed rule.

The device works by applying an electrical stimulus to a person’s skin to help deter a certain behavior.

According to the FDA, there is evidence of a number of risks associated with these devices, including depression, anxiety, worsening of self injury behaviors, symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.

Only one U.S. facility — the Judge Rotenberg Educational Center in Canton, Mass. — uses the device, with roughly 45 to 50 individuals receiving treatment with it.

The FDA drew its conclusion by considering all available evidence, including: clinical and scientific data, input from experts in the field and state agencies, comments from JRC, individuals and parents of individuals on whom ESDs have been used, and disability rights groups, as well as insights from an April 2014 FDA advisory panel.

The FDA rarely proposes banning a device only when seen as necessary to protect public health. The proposal is open for public viewing and comment for 30 days.

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