Regulatory Counsel

0910-AI84 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior

The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA finalized a ban on these devices in 2020, but the D.C. Circuit vacated the final rule in 2021. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling. Now that Congress has removed the statutory basis for the D.C. Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 882.5235 21 CFR 895 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360f 21 U.S.C. 360i 21 U.S.C. 360j 21 U.S.C. 371 No NPRM 12/00/2023 No None No No No No Patricia Kaufman Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-1174 patricia.kaufman@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Silver Spring MD 20993