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.
This rule is effective April 6, 2020. However, compliance for devices currently in use and subject to a physician-directed transition plan is required on September 2, 2020. Compliance for all other devices is required on April 6, 2020.
For access to the docket to read background documents or comments received, go to https://www.regulations.gov/ and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring MD 20993-0002, 301-796-6527, firstname.lastname@example.org.