Preferred Label : Testing of Model Variant;
Alternative definition : FDA: The investigation employed relevant empirical testing of a model variant of the
device involved in the reported adverse event in order to support the identification
of possible causes for the adverse event through plausibility reasoning. A model variant
is not identical to the actual device, but shares relevant characteristics with the
device involved. Relevant testing would typically be based on test methods used for
evaluating safety and performance as described in the latest relevant standards.;
NCI Metathesaurus CUI : CL526753;
Codes from synonyms : 4104;
Origin ID : C139450;
UMLS CUI : C4528482;
Currated CISMeF NLP mapping
- Semantic type(s)
- concept_is_in_subset
