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.
Document
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior
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 the...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
81 FR 24385
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,” thefederalregister.org (April 25, 2016), https://thefederalregister.org/documents/2016-09433/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or-aggressive-behavior.