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HHS/FDA RIN: 0910-AH38 Publication ID: Fall 2016 
Title: Renaming Various Devices as Powered Laparoscopic Tissue Fragmentation Devices; Designation of Special Controls 
Abstract:

This proposal addresses a set of devices that includes laparoscopic power morcellators. The rule is being proposed in order to consolidate and update requirements for various medical devices used in obstetrical or gynecological surgeries that may pose a risk of up-staging cancer in the patient. The consolidation (renaming) will create a single set of requirements to address the risks of such devices, and the update will revise general controls and apply special controls to mitigate the risk and provide adequate assurance of safety and effectiveness. All subject devices are already class 2, and the rule would not up-classify devices.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 884.4600   
Legal Authority: 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. 360j    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2017 
NPRM Comment Period End  03/00/2017 
Final Action  11/00/2017 
Final Action Effective  12/00/2017 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
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 5515,
Silver Spring, MD 20993
Phone:301 796-5678
Email: ian.ostermiller@fda.hhs.gov