CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on July 17, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff Federal Register: Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions Transcript posted for June 12, 2018 Circulatory System Devices Panel meeting Transcript posted for June 14, 2018 Anesthesiology and Respiratory Therapy Devices Panel meeting Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180001 added)