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

A guidance has been posted titled "Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff."

The Food and Drug Administration (FDA) is issuing this guidance to recommend the addition of specific safety statements to the product labeling for laparoscopic power morcellators (LPMs). This recommendation is being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging1 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.

This guidance is being implemented without prior public comment because the agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). FDA believes that immediate implementation of the guidance is needed to assist in addressing a significant public health issue. Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

To view the Guidance, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.pdf.