Product Labeling for Laparoscopic Power Morcellators Guidance for Industry and Food and Drug Administration Staff December 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this 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 LPM containment systems. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.