Date: February 17, 2016
The following new items were added to the CDRH web pages on February 16, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150001 added)
- Mammography Facility Adverse Event and Action Report - February 16, 2016: Boston Diagnostic Imaging