CDRH New Update

The following new items were added to the CDRH web pages on March 13, 2019. Previous CDRH Newitems can be found on the CDRH New webpage. Reorganization of The Center for Devices and Radiological Health Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180017 added) Federal Register: Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens Federal Register: Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions Federal Register: Medical Devices; Inspection by Accredited Persons Program Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051