FDA Guidance

FDA Guidance: Contents of Premarket Submissions for Software Contained in Medical Devices, 5/05

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May, 2005 CDRH published this guidance to industry regarding software used in medical devices and software at blood establishments.

This guidance contains sections on software documentation, risk assessment & management, software change management, software of unknown pedigree (SOUP), virus protection software, and interfaces, networking, and network infrastructure.

Issuing Body

FDA Guidance Documents

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