Preferred Label : Device from Same Lot Evaluated Evaluation Method;
NCIt related terms : Testing of Device from Same Lot/Batch Retained by Manufacturer;
Alternative definition : FDA: The investigation employed relevant empirical testing of the device of the same
lot or batch than that of the suspected device in the reported adverse event in order
to support the identification of possible causes for the adverse event. Testing was
performed using the device retained by the manufacturer (i.e. was not shipped). Relevant
testing would typically be based on test methods used for evaluating safety and performance
as described in the latest relevant standards.;
Codes from synonyms : 11;
Origin ID : C91933;
UMLS CUI : C2984666;
Semantic type(s)
- concept_is_in_subset
