What's New‎ > ‎

FDA/CDRH officially still accepting 2nd Edition submissions until Dec. 31st 2013

posted Aug 7, 2013, 11:30 AM by Unknown user   [ updated Nov 2, 2013, 1:42 PM by Frank O'Brien ]
Just posted this week

" ... FDA will continue to accept declarations of conformity, in support of premarket submissions, to IEC 60601-1 Edition 2:1988 (A1:1991 + A2:1995) and all its recognized Part 1 collateral and Part 2 particular standards until December 31, 2013. Please note that this new transitional period is an extension from a previous date of June 30, 2013. After this extended transition period, declarations of conformity to IEC 60601-1 Edition 2:1988(A1:1991 + A2:1995) and all its recognized Part 1 collateral and Part 2 particular standards will not be accepted. "

More details can be found here on the FDA website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31189
Comments