FDA Panel Calls For More Studies Of Mini-Slings For Urinary Incontinence
This article was originally published in The Gray Sheet
Executive Summary
FDA’s Obstetrics and Gynecology Device panel recommends second-generation mini-slings to treat stress urinary incontinence be subject to 510(k) pre-market clinical trial requirements and additional post-market data collection mandates.
You may also be interested in...
Surgical Mesh And Sling Devices Must Undergo Post-Market Studies
FDA sends post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse and to seven makers of single-incision mini-slings used for stress urinary incontinence.
FDA Panel: Transvaginal Mesh For Prolapse Should Be Class III
Current and future surgical mesh devices for pelvic organ prolapse repair would require PMA submissions under a recommendation last week by FDA’s Obstetrics and Gynecology Devices panel.
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.