CDRH New Update

CDRHNew

Date: November 7, 2016

The following new items were added to the CDRH web pages on November 4, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• 2014 Ebola Virus Emergency Use Authorizations: ReEBOV™ Antigen Rapid Test (Zalgen Labs, LLC) - November 3, 2016
• Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Guidance for Industry and Food and Drug Administration Staff