CDRH New Update

CDRHNew

Date: July 20, 2016

The following new items were added to the CDRH web pages on July 19, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Emergency Use Authorizations - Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150004 added)
• Meeting materials posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
• Need for a National Evaluation System for Health Technology - JAMA article by Drs. Shuren and Califf - link added to National Evaluation System web page
• Webinar Presentation and Transcript posted for Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions