On August 5, 2013, the U.S. FDA announced the extension of the transition date for IEC 60601-1 3rd edition from June 30, 2013 to December 31, 2013. This means FDA will accept pre-market submissions with test reports assessed to IEC 60601-1 2nd edition through the end of the year.
You can read the full notice at:
For more information, please contact G&M Compliance, Inc. at 714.628.1020
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