CDRH New Update

The following new items were added to the CDRH web pages on December 1, 2017. Previous CDRH New items can be found on the CDRH New webpage. Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160047, DEN160018 and DEN150053 added) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160012 and DEN150048 added) Federal Register: Reclassification of Single-Use Female Condom, to be Renamed Single-Use Internal Condom  Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048