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EMDR Device Components Codes Missing 'Device Component Codes' (Doc ID 2500326.1)

Last updated on MAY 11, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Goal

Oracle Argus Safety Version 8.1.2

Regarding FDA requirements and article published on Oracle support portal:
Inclusion in Argus Safety Versions 8.0.1 and Later of FDA Adverse Event Codes as per FDA CDRH eMDR System Enhancements (Doc ID 2363145.1).

In the article published on FDA website they have mentioned 6 items:


1) Device Problem Code DPC hierarchy
2) Manufacturer Evaluation Method Code EMC hierarchy
3) Manufacturer Evaluation Result Code ERC hierarchy
4) Manufacturer Evaluation Conclusion Code ECC hierarchy
5) Patient Problem Code PPC hierarchy
6) Device Component Code DCC hierarchy

But in Argus can only find 5 items in CFG_MEDWATCH_DATA and in CFG_M2.

Where to find the 6th file i.e. Device Component Codes ?

These are required by regulatory authorities.
 

Solution

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In this Document
Goal
Solution
References


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