A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation surgeries. The objective is to prevent potentially cancerous tissue from getting out of the containment systems and spreading the disease to other parts of the body.
On 17 June, FDA published a draft guidance titled Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures. The systems are used to capture benign tissue that is not suspected to contain malignancies during gynecological and other types of laparoscopic power morcellator procedures. They may help prevent potentially cancerous cells from spreading to other parts of the body if they work properly…
