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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices



On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. When finalized, “Computer Software Assurance for Production and Quality System Software” will supplement FDA’s existing guidance, “General Principles of Software Validation” and supersede Section 6: Validation of Automated Process Equipment and Quality System Software.

Per the announcement from the FDA, the intent of the draft guidance is to describe “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate. In addition, it describes various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR (Part 820).

Industry can submit comments on the draft guidance online until November 14, 2022.

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