It has been a while since the TC 194WG 4 produced the final version for the FDIS which was sent to the ISO committee end of March 2010. The FDIS is now finally out for formal voting since September 9th, 2010 with a deadline for voting on November 9th 2010.
Many clinical professionals wonder when the requirements of this new FDIS can be used. For clarification, after an FDIS, only editorial corrections can be made. As a consequence, the requirements of the ISO 14155 FDIS (2010) will not change with exception for some editorial corrections and clinical professionals can thus start using the new version.