SoftwareStandardsandSoftwareValidation.pptVIP

CDRH Software Regulation John F Murray Jr.. Center for Devices Radiological Health US Food and Drug Administration JFM@CDRH.FDA.GOV Public Health and Software What type of Quality do we Want? SOFTWARE IS DIFFERENT Software Quality - Primarily a design issue Custom developed components Complexity Structured development process plus testing Dormant latent defects Software is easy to change Difficult to control changes Significance of changes SOFTWARE RECALLS1983 - 1996 SOFTWARE RECALLSBY DEVICE PANEL Do the regulations recognize this need 21 CFR 820.30 Design Controls 21 CFR 820.30 (a