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GUIDANCE DOCUMENT

Product Labeling for Laparoscopic Power Morcellators Draft Guidance for Industry and Food and Drug Administration Staff February 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2014-D-1804


Docket Number:
FDA-2014-D-1804
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This draft guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this draft guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. FDA is also recommending that manufacturers incorporate into the labeling for these devices information providing greater specificity regarding the risk of use as it relates to age, information regarding the risk of spreading malignant and benign uterine tissue, and information regarding the use of laparoscopic power morcellation containment systems. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.