Applicability
Software used as part of medical-device production or the quality management system.
What Changed
The February 2026 final guidance superseded the September 24, 2025 final guidance.
What Did Not Change
The guidance remains nonbinding. The regulated manufacturer remains responsible for applicable requirements and sufficient evidence.
Practical Impact
Review risk-based assurance terminology, use of scripted and unscripted testing, and the basis for using supplier evidence.
Actions to Consider
Perform a controlled gap assessment. Do not automatically rerun existing validation solely because the guidance was revised.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.