FDA ORA Software Glossary

FDA’ s Office of Regulatory Affairs “GLOSSARY 1 OF COMPUTERIZED SYSTEM AND SOFTWARE DEVELOPMENT TERMINOLOGY” issued in August 1995. This glossary contains definitions for many software engineering and validation terms. In most cases these definitions are taken from external standards organizations. CDRH references this glossary from several guidance documents.

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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