Power Morcellation Containment Devices Placed In FDA Class II
The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.
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A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery. Strength, permeability and leakage testing are all key considerations.
Single-patient lancets will face new special controls and 510(k) submission, while multiple-patient lancets would require a PMA.
The new guidance from the US FDA urges physicians to discuss with patients the benefits and risks of using a laparoscopic power morcellator to remove uterine fibroids, and adds some language around LPM containment systems that wasn’t included in the draft of the document.