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GUIDANCE DOCUMENT

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures Guidance for Industry and Food and Drug Administration Staff May 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-0737
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. This guidance applies to the tissue containment systems used during a power morcellation procedure for gynecologic use and for general use and provides recommendations on (1) test methods, (2) test parameters, and (3) test acceptance criteria. The recommendations are intended to promote consistency and facilitate efficient review of gynecologic and general laparoscopic power morcellation containment systems submissions. The recommendations are being made to ensure that the non-clinical test methods can effectively identify safety issues related to damage of the tissue containment system and subsequent leakage of any tumor cells and other contents.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0737.

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