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FDA Computer Software Assurance Guidance

This is an FDA guidance document titled "Computer Software Assurance for Production and Quality Management System Software," issued February 3, 2026. It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose.

Organizations:
US FDA
Topics:
Software Medical Devices

Version Timeline

Chronological release history

FDA Computer Software Assurance Guidance

Version milestone

Publication Date

Feb 3, 2026

Effective Date

Not specified

Main updates: It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose.
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