Date: August 30, 2016
The following new items were added to the CDRH web pages on August 29, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Emergency Use Authorization - LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.)
- Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff
- Executive Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting