CDRH New Update

The following new items were added to the CDRH web pages on November 13, 2017. Previous CDRH New items can be found on the CDRH New webpage. CLIA Waiver by Application Decision Summaries - CW170003 added Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System