CDRH New Update

CDRHNew

Date: November 30, 2016

The following new items were added to the CDRH web pages on November 29, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140040 added)
• Federal Register: Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability
• Presentation and Transcript added to Webinar - Final Guidance Documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - November 21, 2016