CDRH New Update

CDRHNew

Date: June 2, 2016

The following new items were added to the CDRH web pages on June 1, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Federal Register: Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Revie...
• MQSA National Statistics
• Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stockert 3T Heater-Cooler System: FDA Safety Communication