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Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0737
This draft guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power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 cancer cells and other contents.
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