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 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/
FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10
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
Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems
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