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  1. Economic Impact Analyses of FDA Regulations

Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Final Rule) Regulatory Impact Analysis

The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.

Regulatory Impact Analysis

Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Final Rule) (PDF - 176KB)

Federal Register: 85 FR 13312 - March 6, 2020

Docket No.: FDA-2016-N-1111