TITLE: Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
AGENCY: Food and Drug Administration, HHS
ACTION: Final rule
SUMMARY: 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.
DATES: This rule is effective 6 April 2020. However, compliance for devices currently in use and subject to a physician-directed transition plan is required on 2 September 2020. Compliance for all other devices is required on 6 April 2020.
The docket folder on Regulations.gov provides access to primary and supporting documents for this rulemaking as well as the comments received: https://www.regulations.gov/docket?D=FDA-2016-N-1111.