CDRH New Update

CDRHNew

Date: February 12, 2016

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

• Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150011 added)