The FDA wants feedback on its newly issued draft guidance for practices relating to computers and automated data processing systems used as part of production or quality systems.
The FDA is taking comments on its new draft guidance, “Computer Software Assurance for Production and Quality System Software,” until Nov. 14.
The agency’s goal is to offer recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems. FDA said the new guidelines follow manufacturing advances in areas such as automation, robotics and simulations that can improve the quality, safety and availability of medical devices.
FDA said medical device manufacturers have asked not only for greater clarity on validating production and quality software, but also a “more iterative, agile approach.”
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