Date: June 17, 2015
The following new items were added to the CDRH web pages on June 16, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Guidance for Industry and Food and Drug Administration Staff
- Class I Medical Device Recall: HeartWare Ventricular Assist System - Damaged Alignment Guides / Connection Pins May Cause Pump to Stop
- Public Meeting - Reauthorization of the Medical Device User Fee Program, July 13, 2015