Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician- directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA is publishing this notification in response to petitions for an administrative stay of action in accordance with regulatory requirements.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 882 and 895 [Docket No. FDA-2016-N-1111] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; notification of administrative stay. SUMMARY: The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician-directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA is publishing this notification in response to petitions for an administrative stay of action in accordance with regulatory requirements. DATES: FDA is administratively staying temporarily the final regulation published on March 6, 2020 ( 85 FR 13312 ), for those devices in use on specific individuals as described in SUPPLEMENTARY INFORMATION . FDA will publish a document in the Federal Register lifting the stay or taking further action as needed. ADDRESSES: For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket. FOR FURTHER IN…
Other Federal Register documents from the same docket.
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior
Citation: 85 FR 50950
