Yesterday, the U.S. Food and Drug Administration released a proposed rule to ban electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. (FDA’s full press release follows below.)
Comments must be received by May 28, 2024. The proposed rule and instructions for commenting can be found in the notice of proposed rulemaking published in the Federal Register.
FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
The following is attributed to Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or aggressive behavior, a step rarely taken by the agency. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. This is the second time the FDA has proposed a ban of these particular devices.
ESDs deliver electrical shocks through electrodes attached to an individual’s skin to attempt to reduce or stop harmful behaviors. This proposed rule proposes to ban ESDs intended for self-injurious and aggressive behaviors. Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions. These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.
The proposed rule, if finalized, will remove ESDs from the market, and the devices will no longer be considered legally marketed. The FDA has information to indicate that only one facility is currently using these devices in the United States, which is 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. Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans. The FDA intends to consider the needs of these patients should we finalize the proposed ban.
The FDA’s first ban of these devices in 2020 was challenged in court and, in effect, annulled (vacated) based on the court’s interpretation of the FDA’s authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Since that decision, changes to the FD&C Act make clear that the FDA has authority to issue a ban such as the previous ban on ESDs for self-injurious or aggressive behavior, which applies to specific intended uses.
This proposed rule analyzes the new information, available since the FDA engaged in the prior rulemaking, relating to the risks and effects of ESDs and treatment of self-injurious and aggressive behavior. Evidence considered by the agency included clinical and scientific data, input from experts in the field and state agencies, comments received from the previous proposed rule to ban ESDs, input from patients and parents of individuals who have been treated with ESDs, and disability rights groups, as well as insights from FDA advisory panels. Importantly, 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.
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.
The Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior will be open for comment until May 28, 2024. The FDA will then review and consider comments before determining whether to issue a final rule.
Related Information:
- Medical Device Bans
- Final Rule (Effective: April 6, 2020) (Vacated: July 6, 2021): Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- FDA News Release (March 04, 2020): FDA Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- FDA News Release (April 22, 2016): FDA Proposes Ban on Electrical Stimulation Devices Intended to Treat Self-injurious or Aggressive Behavior