March 18, 2010 – Medical Device Today Article reprinted from “The Gray Sheet” – March 15, 2010 FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center
Updated EN60601 Series FAQ to be Posted on Cenelec site soon
Updated EN60601 Series FAQ in regard to the MDD & AIMDDD to be posted on CENELEC website in the near future The document is an update to the current posted document issued 9 October 2009 on the CENELEC site
Industry Update Amendment 1 of…
Industry Update Amendment 1 of IEC 60601-1:2005 is at the 1st committee draft stage and the estimated pub date June 2012 http://ow.ly/1nuKP
AAMI News: Online Med Dvc Stan…
AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg
FDA Formally Recognize IEC 60601-1, 3rd ed.
The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.
