CDRH New Update

CDRHNew

Date: August 4, 2017

The following new items were added to the CDRH web pages on August 3, 2017. Previous items can be found on the CDRHNew Page.

• Emergency Use Authorizations - Added TaqPath Zika Virus Kit (Thermo Fisher Scientific)
• Presentation and Transcript Added to Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals - July 26, 2017
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150053 added)