Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 30, 2020
Language(s):
English
Format:
Text
Subject(s):
Laparoscopy
Morcellation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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 upstaging2 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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (7 pages)).
NLM Unique ID:
9918250312506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918250312506676