CDRH New Update

The following new items were added to the CDRH web pages on December 26, 2017. Previous CDRH New items can be found on the CDRH New webpage. Mammography Facility Adverse Event and Action Report – December 12 2017 (Updated December 26, 2017): EVDI Desert Breast Ctr - Country Club Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160014 added) Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of Reagents for Molecular Diagnostic Instrument Test Systems Federal Register: Hematology and Pathology Devices; Classification of Flow Cytometric Test System for Hematopoietic Neoplasms Federal Register: Neurological Devices; Classification of Computerized Behavioral Therapy Device for Psychiatric Disorders Federal Register: Neurological Devices; Classification of External Vagal Nerve Stimulator for Headache Federal Register: Radiology Devices; Classification of Rectal Balloon for Prostate Immobilization