Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior
Information
Type
Proposed Rule
Regulated products
Published
April 25, 2016
Last updated
April 25, 2016
Description
Document number 2016-09433. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)