CDRH New Update

CDRHNew

Date: August 18, 2015

The following new items were added to the CDRH web pages on August 17, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
• Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff
• Infections Associated with Reprocessed Duodenoscopes (Updated)
• Federal Register: Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid
• Federal Register: Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments
• Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication
• Public Workshop - Physiological Closed-Loop Controlled Devices, October 13-14, 2015
• Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff