CDRH New Update

The following new items were added to the CDRH web pages on February 14, 2019. Previous CDRH New items can be found on the CDRH New webpage. Press Release: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180058 added) Consumer Information on: MANTA Vascular Closure Device - P180025 FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants Presentations posted for February 12, 2019 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee