FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software

25th September 2025

FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software

Summary: On 23rd September 2025, the U.S. Food and Drug Administration (FDA) issued final guidance on Computer Software Assurance (CSA) for production and quality system software. This guidance introduces a risk-based approach to validate software used in medical device manufacturing and quality systems, aiming to enhance product quality and regulatory compliance. Key recommendations include identifying the software's intended use, assessing associated risks, determining appropriate assurance activities, and maintaining objective evidence throughout the software's lifecycle. This approach supports efficient resource use while ensuring that software remains in a validated state, consistent with 21 CFR 820.70(i). The guidance supersedes Section 6 of the FDA's "General Principles of Software Validation" guidance.

Link: Computer Software Assurance for Production and Quality System Software

Back to Recent News