Eisner Safety Consultants

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 (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 [...]

Follow FDA CDRH (Device Info & CDRH Industry) on Twitter http://ht.ly/1Lc7D Available Twitters as of May 14, 2010 FDADeviceInfo – Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics. FDAcdrhIndustry – Helpful links, information, and news for industry related to medical device and radiation-emitting products.

Devicemakers Given Three Years to Transition to New Standard From  FDA News Devices & Diagnostic Letter March 29, 2010 Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices. Manufacturers will have three years to [...]