FDA Software Standards Recognition 2000

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:
ISO/IEC 12207
IEEE/EIA 12207.0
UL 1998
IEEE 1074
IEEE 1012

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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