Regulatory Counsel, Center for Devices and Radiological Health

0910-AH38 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Renaming Various Devices as Powered Laparoscopic Tissue Fragmentation Devices; Designation of Special Controls

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 884.4600 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 No NPRM 01/00/2017 NPRM Comment Period End 03/00/2017 Final Action 11/00/2017 Final Action Effective 12/00/2017 Undetermined None Undetermined No No No Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993