CDRH New Update

CDRHNew

Date: July 1, 2015

The following new items were added to the CDRH web pages on June 30, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• 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
• Federal Register: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Summary Information for: PROMUS Element™ Plus and Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent Systems (Monorail™ and Over-the-Wire)