CDRH New Update

CDRHNew

Date: January 22, 2016

The following new items were added to the CDRH web pages on January 21, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Implanted Blood Access Devices for Hemodialysis; Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
• PMA Final Decisions for November 2015
• Public Workshop - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, March 18, 2016 (New Date)
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance - February 11, 2016
• Federal Register: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability