The FDA wants feedback on its newly issued draft guidance for practices relating to computers and automated data processing systems used as part of production or quality systems.
The FDA is taking comments on its new draft guidance, “Computer Software Assurance for Production and Quality System Software,” until Nov. 14.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.”
“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 said.
When finalized, the guidance will supplement FDA”s “General Principles of Software Validation” and supersede Section 6, “Validation of Automated Process Equipment and Quality System Software.”
These potential recommendations shouldn’t be confused with validation of software in medical device (SiMD) or validation of software as a medical device (SaMD) products such as diagnostic algorithms.
“This draft guidance is intended to describe ‘computer software assurance’ as a risk-based approach to establish confidence in the automation used for production or quality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,” the FDA notice said, “and describe 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 (Part 820).”
Software testing by itself isn’t enough. FDA identifies the draft guidance framework as first identifying the intended use, then determining the risk-based approach, determining appropriate assurance activities, and establishing the appropriate record.
The entire draft guidance document can be downloaded as a PDF by clicking here.