Obstetrical and Gynecological Devices - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair (US Food and Drug Administration Regulation) (FDA) (2018 Edition‪)‬

The Law Library presents the complete text of the Obstetrical and Gynecological Devices - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury. The Agency is reclassifying surgical mesh for transvaginal POP repair on its own initiative based on new information.

This ebook contains:
- The complete text of the Obstetrical and Gynecological Devices - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure