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Summary: Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (Proposed Rule)

Summary: Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (Proposed Rule)

The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious 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. FDA is proposing to include in this ban both new devices and devices already in distribution and use.

Regulatory Impact Analysis

Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (Proposed Rule) (PDF - 106KB)

Federal Register: 81 FR 24385, April 25, 2016

Docket: FDA-2016-N-1111