| NEWS: FDA Recognizes 3rd Edition with June 30, 2013 transition deadline
On June 10, 2010 FDA officially announced its recognition of the 3rd edition of IEC 60601 in the Federal Register. FDA will continue to accept declarations of conformity to UL 60601 2nd edition until June 30, 2013 for premarket submissions in the United States.
Link to FDA Document recognizing 3rd Edition of IEC 60601:
Service options for 3rd Edition
At the leader in product safety for the medical industry, UL's global experts can help you through the transition from 2nd to 3rd edition. To find out more about the training and service options UL provides for 3rd edition, visit UL's 60601 webpage or contact UL at Medical.Inquiry@us.ul.com .
New Health Sciences LinkedIn Group
Join UL Health Sciences' new LinkedIn Group for regular updates from UL and your peers on regulatory decisions surrounding IEC 60601.
Latest Version of "The 3rd Edition Update available
UL recently released the latest version of our industry paper "The 3rd Edition Update: June 2010", which provides the latest industry adoption status preceeding FDA's decision. You can download your copy from the UL University Thought Leadership page. |
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