Date: June 20, 2016
The following new items were added to the CDRH web pages on June 17, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Emergency Use Authorizations - Added Aptima® Zika Virus Assay (Hologic, Inc.)
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff