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HHS/FDA | RIN: 0910-AI22 | Publication ID: Fall 2018 |
Title: ●Banned Devices; Final Ban on Electrical Stimulation Devices Used for Self-Injurious and Aggressive Behavior | |
Abstract:
FDA is finalizing a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior. FDA has determined that these devices present substantial and unreasonable risks of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. In the proposed rule, FDA sought comments on its proposal to ban these devices and on associated issues. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Not subject to, not significant | |
CFR Citation: 21 CFR 882.5235 21 CFR 895.105 | |
Legal Authority: 21 U.S.C. 351 and 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 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993 Phone:301 796-5678 Email: ian.ostermiller@fda.hhs.gov |