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A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery.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.
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The guidance document explains the history of and requirements for electronic submissions of 510(k)s.