Eisner Safety Consultants

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 – 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/ Continue reading Eisner Safety Consultants Newsletter #6 Now Online

NAMSA is offering seminars on Biocompatibility of Medical Devices in Massachusetts, Minnesota & Singapore Aug thru Oct, 2010 http://ht.ly/25q39

FDA Formally Recognized AAMI ES60601-1:2005 (National Version of IEC60601-1:2005 = 3rd edition) as Consensus Standard on 6/10/10.  The transition period indicated on the FDA Consensus Standard web page for AAMI/ANSI ES 60601-1:2005 says in summary that 2nd edition of IEC 60601-1 will be accepted until June 30,2013 and after that only ANSI/AAMI ES60601-1:2005 will be accepted.   Continue reading FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10

Joint FDA/FCC public meeting July 26  & 27, 2010 – Enabling Convergence of Communication & Medical Systems: Update Regulatory & Info Processes http://ht.ly/20oMz

Summary:  The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.” Continue reading Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems