CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on April 25, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. CDRH FOIA - ESSURE 12 Month Interim Postmarket Surveillance Study Report Sept. 2017 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170075 and DEN170010 added) Presentation Slides added to Public Workshop - Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults, April 16, 2018