Eisner Safety Consultants

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.

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 program used to review and clear certain medical devices marketed in the United States…

Leo Eisner to present a regulatory update on IEC 60601-1, 3rd edition, at ‘09 IEEE PSES Conference, Medical Track
On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on [...]

FDA Speeds Process for Banning Bad Trial Investigators
RAPS (In The News) – The US Food and Drug Administration (FDA) has developed new procedures to help speed the process for barring noncompliant clinical trial investigators from future research. The new process will set specific timeframes and assign responsibility for each step to specific areas within the [...]

FDA chief’s pledge signals tougher safety stance

Associated Press article where the FDA Chief Talks Tough and talks about the CDRH Head Resigning, CDER Head Accused of Ethical Violations.