CDRH New Update

CDRHNew

Date: October 25, 2016

The following new items were added to the CDRH web pages on October 24, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• FDA Voice blog: FDA is working with hospitals to modernize data collection about medical devices
• Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel
• Federal Register: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
• Federal Register: Program for Parallel Review of Medical Devices
• Public Workshop - The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance, December 5, 2016
• Reporting Allegations of Regulatory Misconduct
• Class I Medical Device Recall: St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion
• Summary of December 2015 - April 2016 Hospital Inspection Information - October 24, 2016