CDRH New Update

Date: March 22, 2016

The following new items were added to the CDRH web pages on March 21, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Emergency Use Authorizations - Trioplex Real-time RT-PCR Assay (CDC)
• Medical Device Bans
• Federal Register: Patient Engagement Advisory Committee
• Webcast Archive and Presentations posted for Public Workshop - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, March 18, 2016