U.S. Department of Health and Human Services Food and Drug Administration (US FDA) has issued a draft guidance on Computer Software Assurance for Production and Quality System Software on September 13th, 2022. Comments and suggestions regarding this draft document should be submitted to https://www.regulations.gov within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. US FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the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. This draft guidance is intended to: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; and
- describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfil regulatory requirements, such as computer software validation requirements in 21 CFR part 820 (Part 820).
The guidance is not intended to provide a complete description of all software validation principles. US FDA has previously outlined principles for software validation, including managing changes as part of the software lifecycle, in US FDA’s Software Validation guidance (January 2022). This guidance applies the risk-based approach to software validation discussed in the Software Validation guidance to production or quality system software. Guidance additionally discusses specific risk considerations, acceptable testing methods, and efficient generation of objective evidence for production or quality system software.
Compliance with the Quality System regulation, Part 820, is required for manufacturers of finished medical devices to the extent they engage in operations to which Part 820 applies. The Quality System regulation includes requirements for medical device manufacturers to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications (21 CFR 820.70, Production and Process Controls), including requirements for manufacturers to validate computer software used as part of production or the quality system for its intended use (see 21 CFR 820.70(i)). Recommending best practices should promote product quality and patient safety and correlate to higher-quality outcomes.
In recent years, advances in manufacturing technologies, including the adoption of automation, robotics, simulation, and other digital capabilities, have allowed manufacturers to reduce sources of error, optimize resources, and reduce patient risk. US FDA recognizes the potential for these technologies to provide significant benefits for enhancing the quality, availability, and safety of medical devices, and has undertaken several efforts to help foster the adoption and use of such technologies. When final, this guidance is intended to provide recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system.