# Enable FDA eMDR Generation & Manufacturing Report Number Automation

With the 25R3 release, Veeva Safety supports electronic medical device reporting to the FDA and for distribution to partners through the FDA eMDR XML format. This feature introduces the fields and objects required for compliant file generation and submission. In addition, Vault now includes tracking of manufacturer sites and manufacturer report numbers, which it exports to the FDA eMDR XML and the August 2024 version of the FDA MedWatch 3500A form.

After configuring this feature, see <a href="/en/lr/936141/">FDA eMDR Generation Data Mapping</a>  and <a href="/en/lr/01213/">Manage Organizations</a> for more information.

## Update the Organization Layout

Based on your business process, to all applicable _Organization_ object layouts: 

1. Insert the _Manufacturer Site_ <a href="/en/lr/26387/#how-to-add-sections">related object section</a>. 
2. <a href="/en/lr/26387/#columns">Edit the default columns</a> to include:
    * _Site Name_
    * _Site Number_

## Update the Manufacturer Site Layout

To the _Manufacturer Site_ object layout: 

1. Insert the _Site Report Number_ <a href="/en/lr/26387/#how-to-add-sections">related object section</a>. 
2. <a href="/en/lr/26387/#columns">Edit the default columns</a> to include _Site Report Number Status_.

## Update the Product Registration Layout

To the _Product Registration_ object layout: 

1. Insert the _Product-Manufacturer Site_ <a href="/en/lr/26387/#how-to-add-sections">related object section</a>. 
2. <a href="/en/lr/26387/#columns">Edit the default columns</a> to include:
    * _Manufacturer Site_
    * _Product_
    * _Product Registration_
    * _Status_

## Update the Case Product Layout

Based on your business process, in the _Product_ section of all applicable _Case Product_ object layouts, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields: 

* _Manufacturer Site_
* _FDA Reason for Device Non-Evaluation_
* _FDA Manufacturer Report Number_