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New FDA Requirements For 'Similar' Combination Products (Doc ID 2669867.1)

Last updated on MAY 19, 2020

Applies to:

Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.


The FDA have made an update to the technical specifications for the R2 (2.2 DTD) Combo Products (PMSR)

Below is link to document:

The revision history entry; 2020-02-11 1.7

They have:

Added a new value to the data element B.4.k.1 for drug characterization to accommodate a similar device.
Updated the data element B.4.k.18.2 to specify values.
Updated the data element B.4.k.18.3 to use default value.

The most significant change is the addition of a new product type (Similar)

B.4.k.1 Characterization of drug role 1N


If the product in the report is about a similar device, the element value should be 5=Similar Device.

When we have a suspect product (1) from outside the US coded in the case, we should also code the US product that is considered “same/similar” using the selection “5”

Not sure if this new change is needed by July 2020.

Will Oracle provide a patch to fill the new FDA requirement ?


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