This proposed rule, if finalized, would reestablish the ban of electrical stimulation devices (ESDs) for self-injurious or aggressive behavior, following the Agency’s now clarified authority to ban devices intended for human use for specific intended uses. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. The proposed rule, if finalized, would apply to both new devices and devices already in distribution and use. Unquantified benefits would include reduction in adverse effects from using ESDs on individuals, as well as benefits to society in terms of protecting vulnerable populations. We quantify costs for the case in which the affected individuals might move to another facility and costs to the affected entities to read and understand the rule.  We estimate that the annualized costs over 10 years would range between $0.00 million and $9.17 million, with a primary estimate of $4.59 million at both a 7 percent and a 3 percent discount rate.

Regulatory Impact Analysis

Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Proposed Rule) (PDF 327 KB)
Federal Register:  89 FR 20882
Publication Date: 03/26/2024
Docket:  FDA-2023-N-3902