All terms
Use-Related Risk Analysis
Analysis of use scenarios to identify potential use errors and their consequences.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
A URRA links tasks, potential use errors, and resulting harms - feeding human factors validation testing and ISO 14971 risk control decisions.What this means in practice
FDA's human factors guidance expects a documented URRA covering critical tasks, with each tested in summative validation.Cross-references
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See also
Closely related context worth reading.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·2ISO·1
- 1
FDA Human Factors GuidanceVerifiedFDAfda.gov
- 2
FDA - Quality SystemsVerifiedFDAfda.gov
- 3
ISO 13485 Standard PageVerifiedISOiso.org
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