This decision, only the second of its kind, comes after determining that these devices pose an unreasonable risk of harm. ESDs deliver electrical shocks to individuals through attached electrodes, attempting to mitigate harmful behaviors. However, these devices have been found to present various psychological and physical risks, particularly for those with intellectual or developmental disabilities.
The proposed rule aims to remove ESDs from the market entirely, with only one facility currently employing them in the U.S. The FDA acknowledges the need for careful consideration of affected individuals during the transition away from these devices. Notably, changes to the Federal Food, Drug, and Cosmetic Act have reinforced the FDA’s authority to issue such bans, specifically targeting ESDs used for self-injurious or aggressive behavior.
The decision is based on extensive analysis of clinical data, expert input, and feedback from various stakeholders, affirming the risks associated with ESDs for the specified purposes. Importantly, the proposed ban does not extend to aversive conditioning devices used for other purposes or FDA-approved technologies.
Interested parties have until May 28, 2024, to comment on the proposal, after which the FDA will review feedback before finalizing its decision.