CDRH New Update

CDRHNew

Date: October 14, 2016

The following new items were added to the CDRH web pages on October 13, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Software as a Medical Device (SaMD): Clinical Evaluation - Draft Guidance
• UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T Heater-Cooler System: FDA Safety Communication