Earlier this month FDA recognized UL 1998 for software. It followed up in the second half of the month by publishing new supplmentary information sheets for all recognized software standards that explains the recognition and how each could be used to reduce software documentation in submissions.
Subscribers to SoftwareCPR.com can login, go to the Library on this site and search for “Roadmap”. One of the SoftwareCPR educational Roadmaps is on Standards Recognition. It provides a 1 page comparison of the recognition of the 5 software standards currently recognized by FDA as a quick reference. It also provides explanatory information and hot links to relevant FDA documents and web pages.
The 5 software standards currently recognized are: