By Stewart Eisenhart, Emergo Group
US regulators have extended their deadline for IEC 60601-1 3rd Edition medical device electrical standard compliance to December 31, 2013.
The US Food and Drug Administration had previously set a date of June 30,l 2013 for manufacturers of certain electrical medical devices to transition from IEC 60601-1 Edition 2:1988 (IEC 60601-1 2nd Edition) to ANSI/AAMI ES60601-1:2005(R) 2012 (IEC 60601-1 3rd Edition); from that date, the agency would not have accepted declarations of conformity to IEC 60601-1 2nd edition submitted with 510(k), Premarket Approval (PMA) and other medical device registration applications.
Now, no doubt partially in response to feedback from affected manufacturers, the FDA will continue to accept 2nd Edition declarations of conformity in premarket submissions through the end of 2013.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.