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# Power Morcellation Tissue Containment Guidance
- URL: https://www.fdaweb.com/power-morcellation-tissue-containment-guidance/
- Published: 2023-05-25T12:00:00.000Z
- Updated: 2026-09-14T18:34:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154538

FDA has published a guidance, *Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures*, with recommendations it says may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-performance-assessment-tissue-containment-systems-used-during-power-morcellation?utm%5Fmedium=email&utm%5Fsource=govdelivery) says tissue containment systems are used to enable the isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure to excise benign tissue that is not suspected to contain malignancy. The devices are Class II and subject to 510(k) requirements.

In an online [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/35c15af?ref=fdaweb.com), CDRH says the guidance is intended to:

- provide information to industry about the recommendations on non-clinical test methods, test parameters, and test acceptance criteria to support premarket submissions for gynecologic and general use of laparoscopic power morcellation tissue containment systems;
- support manufacturers in complying with special controls related to non-clinical performance data for laparoscopic power morcellation tissue containment systems for gynecologic and general use; and
- ensure the non-clinical test methods can help mitigate safety issues related to damage of the tissue containment system and subsequent leakage of cancer cells.