FDA Reclassifies Pelvic Mesh Devices As High-Risk, Orders Premarket Approval

(January 4, 2016, 1:30 PM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Jan. 4 issued final orders reclassifying pelvic mesh devices intended to treat pelvic organ prolapse (POP) from moderate-risk Class II to high-risk Class III devices and requiring manufacturers of the devices to obtain premarket approval (PMA) to show the safety and effectiveness of using surgical mesh to treat pelvic organ prolapse....

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