FDA Wades Into Social Media, Finally NPR article on the FDA starting into discussions of how to deal with social media. This article poses some questions that FDA has in mind about the social media sphere.
Japan Roll Out of 3-Tiered Review System for Medical Devices
Japan Rolls Out Three-Tiered Review System For Medical Devices The Gray Sheet article (posted on Medical Devices Today website) on Japan’s roll out of a new three-track medical device review system. The tracks will be brand-new, improved and “me-too” devices.
IOM to Study Premarket Clearance Process for Medical Devices
Institute of Medicine to Study Premarket Clearance Process for Medical Devices FDA Press release, Sept 23, 2009 – The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification
Eisner Safety Consultants Newsletter #1 Available
ESC Newsletter #1 – Just Released This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ’09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment
UL Open House Camas, WA Oct 5, 2009
Underwriters Laboratories is having an Open House on Wed Oct 5, 2009 They will be offering some educational opportunities along with information booths, prizes and refreshments. For more info on the open house click here.
