Reason for Non-Evaluation ICSR Terminology

Terminology used in Individual Case Safety Reports to specify a reason for non-evaluation of a problematic medical product, section F3.3 of FDA MedWatch Form. (NCI Thesaurus)

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Reason for Non-Evaluation

The reason why the problematic device has not been evaluated by the manufacturer. Examples include: device received in a condition which made…

Reason for Non-Completion

The reason that a subject was discontinued from a clinical trial.

Reason for Narrative

The explanation why a summary was necessary for a clinical study.

Reason for Direct Part Exempt Marking

An explanation why a medical device product is exempt from direct part marking.

Reason for Denial

The explanation why a particular action was rejected or denied.

Reason Code

A coded value specifying the rationale for an activity or entity.