Eisner Safety Consultants

FDA 510(k) Process Under the Microscope: How Will Changes Impact You? – Newport Beach, Ca 7/29/10 CA Healthcare Institute http://ht.ly/2fbvs

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

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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 [...]

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.”