Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Information
Type
Rule
Regulated products
Published
March 6, 2020
Last updated
March 6, 2020
Description
Document number 2020-04328. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)