All terms
Substantial Equivalence
The legal standard a 510(k) device must meet versus a predicate.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
A device is substantially equivalent if it has the same intended use as the predicate and either the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness, with performance data demonstrating equivalent safety and effectiveness.What this means in practice
Substantial equivalence is the legal foundation of the 510(k) pathway. FDA decisions hinge on careful predicate selection and side-by-side comparisons of indications, technology, and performance.Cross-references
Used by
Things that build on this term.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·1European Commission·1IMDRF·1
- 1
The 510(k) Program GuidanceVerifiedFDAfda.gov
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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