# Enable FDA MedWatch 3500A: August 2024 Version

Learn how to configure your Vault for the latest FDA MedWatch 3500A report fields.

## About the Feature

With the 24R3 release, Vault Safety generates FDA MedWatch 3500A forms using the version published by the FDA in August 2024. The new version is available for preview, submission, and distribution of ICSRs in Vault Safety for drug, biologic, medical device, and clinical trial cases.

After configuring this feature, your Vault generates the August 2024 version of the form only, not the October 2015 version. For more information about field mapping, see <a href="/en/gr/01223/">FDA MedWatch 3500A (August 2024 Version) Generation Mapping</a>.

## Prerequisite

To enable this feature in your Vault, contact <a class="external-link " href="https://support.veeva.com/hc/en-us" target="_blank" rel="noopener">Veeva Support<i class="fa fa-external-link" aria-hidden="true"></i></a> and then complete the configuration described on this page.

## Update the Case Product Layout

Complete the following steps to add the _Third-party servicer for device?_ field to the _Case Product_ object layout for devices:

1. Navigate to **Admin > Configuration > Objects > Case Product > Layouts > Device Detail Page Layout**.
2. In the _Device Information_ section, add the **Third-party servicer for device?** field.
3. Select **Save**.

### Update the Case Layout

Complete the following steps to update the gender fields on applicable _Case_ object layouts:

1. Navigate to **Admin > Configuration > Objects > Case > Layouts > [layout]**.
2. In the _Patient_ section, update the label of the _Gender_ control field to _Sex_:
   1. To identify the correct field, hover over the existing _Gender_ field and ensure the dialog says `Combined Control for: (gender_value__v), (gender_reason_omitted__v)`
   2. Select the **Edit** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-edit-icon.png " alt="Alt Text" style="" />) icon on the field.
   3. In the _Edit Gender_ dialog, select the **Specify different Label and Help Content** checkbox.
   4. In the **Label** field, enter _Sex_.
   5. Select **Done**.
3. In the _Patient_ section, add the **Gender** control field with the **Slider** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" />) icon. Identify the control field by the name `case_gender_identity_control__c`.
4. Select **Save**.

## Update the Organization Layout

Complete the following steps to add the _Manufacturer Site Number_ field to the applicable _Organization_ object layouts:

1. Navigate to **Admin > Configuration > Objects > Organization > Layouts > [layout]**.
2. In the applicable section, add the **Manufacturer Site Number** field.
3. Select **Save**.

## Update the Product Registration Layout

Complete the following steps to add the _FDA Product Type_ field to the _Product Registration_ object layout:

1. Navigate to **Admin > Configuration > Objects > Product Registration > Layouts > Product Registration Detail Page Layout**.
2. In the applicable section, add the **FDA Product Type** field.
3. Select **Save**.