Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
other · Food and Drug Administration · Rule · Published 2020-03-06 · Effective 2020-04-06 · 85 FR 13312
Document
Document number
2020-04328
Federal Register citation
85 FR 13312
CFR reference
21 CFR 882
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.