FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help ensure confidence in computers and automated data processing systems used in the production of medical devices.

Published in mid-September, the draft guidance, “Computer Software Assurance for Production and Quality System Software,” defines “computer software assurance” as a risk-based approach to assessing the quality and accuracy of automation used in medical device production or quality systems. Further, the draft guidance describes various methods and testing activities that can be used to establish computer software assurance in conformity with FDA requirements.

Once finalized, the guidance is intended to supplement the FDA’s current guidance, “General Principles of Software Validation.”

Read the text of the FDA’s draft guidance on computer software assurance for production and quality system software.

Comments on the draft guidance are due by November 14th and can be submitted through the Regulations.gov website.

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