CDRH New Update

CDRHNew

Date: March 14, 2016

The following new items were added to the CDRH web pages on March 11, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• FDA-Industry MDUFA IV Reauthorization Meeting, February 18, 2016
• Letter to First Diagnostic Corporation regarding the ATFirst’s One Step Zika Antibody Test
• Letter to Texas Children’s Hospital and Houston Methodist Hospital regarding the Zika Direct Test
• Meeting materials posted for March 15, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• Meeting materials posted for March 16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• MQSA Insights - States as Certifiers: Who They Are and What They Do