USA – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance

Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked the agency to align some of the language in the document with the recent International Council for Harmonisation’s (ICH) Q9 guidance, exclude system lifecycle tools from the guidance and include information on cybersecurity.

The draft guidance details a risk-based approach to “establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate” as well as steps for validating the software and its appropriate use. When implemented, FDA said the framework will help meet the requirements of 21 CFR 820.70(i), which dictates the maintenance schedule requirements of medical equipment. (RELATED: FDA drafts guidance on device production and quality system software assuranceRegulatory Focus 12 September 2022)

The guidance, when finalized, is intended to replace Section 6 of the “General Principles of Software Validation” (GPSV) final guidance published in January 2002 on validation of automated process equipment and quality system software…