FDA tries again to ban electrical stimulation devices

The US Food and Drug Administration (FDA) is taking a second attempt at banning electrical stimulation devices (ESD) for the treatment of aggressive or self-injurious behavior after Congress shored up the agency’s device ban authorities.

Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH), issued a statement laying out the agency’s argument for banning the devices. He said the devices are often used on patients with intellectual or developmental disabilities that make it hard for them to speak out about their treatment or make their own decisions. He also noted that the devices could cause a slew of psychological harms including depression, anxiety and post-traumatic stress disorder (PTSD), and may cause physical trauma such as pain and skin burns.

FDA previously issued a final rule to ban the devices in 2020 after first proposing to do so in 2016. As was the case during the previous ban attempt, FDA said it is only aware of these devices being used at a single facility, the Judge Rotenberg Education Center in Canton, Massachusetts.

“We estimate around 50 individuals currently have a treatment plan that includes the use, or potential use, of an ESD,” Faris said. (RELATED: FDA Bans Electrical Stimulation Devices for Aggressive, Self-Injurious Behavior, Regulatory Focus 4 March 2020)

After its previous attempt to ban the devices, the Court of Appeals for the District of Columbia Circuit ruled that the agency did not have the authority to ban a product for some of its intended uses. Following the ruling, Congress gave FDA specific authority to ban some of a device’s intended uses under the Food and Drug Omnibus Reform Act of 2022 (FDORA).

FDA has used its authority to ban medical devices sparingly and has only successfully banned two devices in its history, prosthetic hair fibers in 1983 and powdered medical gloves in 2016.

If finalized, the rule would ban use of the devices to treat patients who may harm themselves or exhibit aggressive behavior. FDA said that many patients that have been subject to these devices have developmental disabilities such as autism spectrum disorder, Down syndrome, and Tourette syndrome.

“Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans,” he added. “The FDA intends to consider the needs of these patients should we finalize the proposed ban.”

The Judge Rotenberg Education Center was the institution that challenged FDA’s 2020 rule in court and is a controversial treatment center that has used electroshock behavior modification that has been criticized by several organizations, including the United Nations.

Faris said the new proposed rule takes into consideration new information FDA has aggregated from researchers, experts, patients, disability rights groups, and additional comments from its previous final rule docket.

“The new information supported and did not alter the FDA’s previous determinations regarding the risks and benefits associated with these devices when used for self-injurious or aggressive behavior, or the agency’s conclusion that these devices present unreasonable and substantial risk of illness or injury to the public,” he added.

While ESDs would be banned to treat self-injurious or aggressive behavior if the rule is finalized, it would still allow researchers to study such devices as investigational devices if sponsors meet FDA's requirements.

“This proposed rule applies only to ESDs intended to be used for self-injurious or aggressive behavior and does not apply to aversive conditioning devices intended to be used for other purposes, such as those used for smoking cessation, which are outside the scope of this rule, or other FDA-cleared or approved devices or technologies,” Faris added.

Stakeholders can comment on the proposed rule on www.regulations.gov under docket no. FDA-2023-N-3902 until 28 May.

FDA proposed rule

FDA tries again to ban electrical stimulation devices

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