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

Last updated on JULY 13, 2023

Applies to:

Goal

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

Below is link to document:

https://www.fda.gov/media/132096/download

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

  1=Suspect
  2=Concomitant
  3=Interacting
  5=Similar

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 ?
 

Solution

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