CDRH New Update

CDRHNew

Date: February 16, 2016

The following new items were added to the CDRH web pages on February 12, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
• Summary Information for: Animas Vibe System
• Federal Register: Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Check the CDRH Customer Service Score
• Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia