CDRH New Update

CDRHNew

Date: August 17, 2015

The following new items were added to the CDRH web pages on August 14, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Check the CDRH Customer Service Score
• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability
• Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040
• Federal Register: Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: National Mammography Quality Assurance Advisory Committee, Renewal
• Federal Register: Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments
• Public Workshop - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19-20, 2015