# Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
> **Food and Drug Administration** · Final rule. · Published 2020-03-06 · Effective 2020-04-06 · 85 FR 13312
## Document
- **Document number:** 2020-04328
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 85 FR 13312
- **CFR reference:** 21 CFR 882
- **Publication date:** 2020-03-06
- **Effective date:** 2020-04-06
- **HHS docket:** Docket No. FDA-2016-N-1111
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior)
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