2025-18468: Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Computer Software Assurance for Production and Quality System Software." FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.
The agency’s own summary, as published.
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