CDRH New Update

CDRHNew

Date: August 14, 2015

The following new items were added to the CDRH web pages on August 13, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• 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of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance for Industry and Food and Drug Administration Staff
• 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
• Stakeholder Meeting - MDUFA Reauthorization, September 15, 2015