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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. |
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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 |
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 |
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Timetable:
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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 5454, Silver Spring, MD 20993 Phone:301 796-5678 Email: ian.ostermiller@fda.hhs.gov |