Eisner Safety Consultants

CDRH Webinar to discuss 2 reports: 510(k) premarket review process and the use of science in CDRH’s regulatory decision making process to respond to questions & concerns will be on 31-Aug-10 http://ht.ly/2vNw7

Just Say No to FDA’s Idea of Transparency from MD&DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process

Device Industry Critic to Join CDRH as first Deputy Director of Science? – From Medical Device Summit http://ht.ly/2s5c0

#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH

FDA CDRH Last of 3 Town Hall Discussions Irvine, CA – Director of CDRH & Senior Staff, October 7, 2010 http://ht.ly/2aT7X