BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 25.11.2014

Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled "Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators." FDA is issuing this guidance to recommend the addition of specific safety statements to the product labeling for laparoscopic power morcellators (LPMs). The Agency is making these recommendations 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 believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.

Source: Federal Register — Food and Drug AdministrationOpen original release →