# Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
> **Food and Drug Administration** · Final order. · Published 2016-01-05 · Effective 2016-01-05 · 81 FR 354
## Document
- **Document number:** 2015-33165
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 354
- **CFR reference:** 21 CFR 884
- **Publication date:** 2016-01-05
- **Effective date:** 2016-01-05
- **HHS docket:** Docket No. FDA-2014-N-0297
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/01/05/2015-33165/obstetrical-and-gynecological-devices-reclassification-of-surgical-mesh-for-transvaginal-pelvic)
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