CDRH New Update

The following new items were added to the CDRH web pages on September 29, 2017. Previous items can be found on the CDRHNew Page. CDRH FOIA: Added ESSURE 6 Month Interim Postmarket Surveillance Study Report CLIA Waiver by Application CLIA Waiver by Application Decision Summaries Reduced Medical Device User Fees: Small Business Determination (SBD) Program Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Draft Guidance for Industry and Food and Drug Administration Staff Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Draft Guidance for Industry and Food and Drug Administration Staff Federal Register: Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation Federal Register: Classification and Requirements for Laser Illuminated Projectors Federal Register: Display Devices for Diagnostic Radiology Federal Register: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers