FDA acts to increase the safe use of laparoscopic power morcellators

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FDA acts to increase the safe use of laparoscopic power morcellators

On 25th Febraury 2020, the U.S. Food and Drug Administration (FDA) is announcing two actions to promote the safe and effective use of laparoscopic power morcellators during gynecologic surgery:

  • Clearance of updated labeling information for a containment system used with laparoscopic power morcellators during gynecologic surgery.
  • Availability of a draft guidance, "Product Labeling for Laparoscopic Power Morcellators."

When finalized, this guidance will provide device manufacturers with recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators to better inform patients and health care providers of the device’s risks.

Read the updated Safety Communication:

https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellation?utm_campaign=2020-02-25%20Safety%20Comm%20laparoscopic%20power%20morcellators&utm_medium=email&utm_source=Eloqua

 

Link for draft guidance “Product Labeling for Laparoscopic Power Morcellators”:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-labeling-laparoscopic-power-morcellators?utm_campaign=2020-02-25%20Safety%20Comm%20laparoscopic%20power%20morcellators&utm_medium=email&utm_source=Eloqua