CDRH New Update

CDRHNew

Date: January 6, 2016

The following new items were added to the CDRH web pages on January 5, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair; Final Rule
• Class I Medical Device Recall: Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly
• Federal Register: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018 added)
• La FDA le recomienda a los proveedores de servicios de salud detener el uso de los paquetes y bandejas con material quirúrgico de Customed, Inc.: Comunicación de Seguridad de la FDA
• The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication