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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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.
The five products include a conditioning tool for eating disorders, a system that evaluates the properties of esophogeal tissue, and a tool used to measure the strain on an orthopedic implant during surgery.