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 1st Deputy Dir of Science?
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 Med Elect Equip Std
#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 Oct 7, ’10 in Irvine, CA
FDA CDRH Last of 3 Town Hall Discussions Irvine, CA – Director of CDRH & Senior Staff, October 7, 2010 http://ht.ly/2aT7X
Eisner Safety Consultants Newsletter #6 Now Online
Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/