News/Blog

Manufacturers of Medical Equipment Have More Time to Comply with IEC 60601-1, 3rd Edition

by G&M Compliance (August 6, 2013)

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:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31189

For more information, please contact G&M Compliance, Inc. at 714.628.1020