CDRH New Update

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon June 25, 2019. To view listings for other dates, see CDRH New - News and Updates.

Clinical Investigations for Prostate Tissue Ablation Devices - Draft Guidance for Industry and Food and Drug Administration Staff FDA In Brief: FDA seeks to advance safe and effective prostate tissue ablation devices by outlining clinical study recommendations for manufacturers Federal Register: Clinical Investigations for Prostate Tissue Ablation Devices Federal Register: Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization