Morcellation Containment System Guidance Stresses Leak Detection, Prevention
A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery.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.
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The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.