# Enable FDA MedWatch 3500A

With the 24R3 release, Veeva Safety generates FDA MedWatch 3500A forms using the version published by the FDA in August 2024. The new version is available in Vault for preview, submission, and distribution of ICSRs 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/lr/01223/">FDA MedWatch 3500A (August 2024 Version) Generation Mapping</a>.

## 26R2 Update: FDA MedWatch 3500A: September 2025 Version

With the 26R2 release, Veeva Safety supports the generation of the latest version of the FDA MedWatch 3500A form, published by the FDA in September 2025. The new version is available for preview, submission, and distribution of ICSRs for drug, biologic, medical device, and clinical trial cases. In addition, this feature introduces an _Application Setting_ that allows you to determine <a href="/en/lr/802644/">which version of the FDA MedWatch 3500A form</a> your Vault generates. Previously, you had to contact your Veeva Representative to configure the version for your Vault. See [(26R2) Configure FDA MedWatch 3500A: September 2025 Version][1] to configure your Vault for the updated feature.

## Update the Case Product Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Third-party servicer for device?_ field to the _Case Product_ object layout for devices.

## Update the Case Layout

To update the gender fields on applicable _Case_ object layouts:

1. Navigate to **Admin > Configuration > Objects > Case > Layouts > [layout]**.
2. 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. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> 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

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Manufacturer Site Number_ field to applicable _Organization_ object layouts.

## Update the Product Registration Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _FDA Product Type_ field to the _Product Registration_ object layout.

## (26R2) Configure FDA MedWatch 3500A: September 2025 Version {#r262}

To configure which version of the <a href="/en/lr/802644/">FDA MedWatch 3500A form</a> your Vault generates and support the September 2025 version of the FDA MedWatch 3500A form, complete the following procedures.

### Update Submission and Distribution Settings

To configure which version of the FDA MedWatch 3500A form your Vault generates:

1. Navigate to **Admin > Settings > Submission and Distribution Settings**.
2. Select **Edit**.
3. In the _MedWatch 3500A Version_ field, select a version of the FDA MedWatch 3500A form.
4. Select **Save**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
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    <div class="alert-text">
      <p><strong>Note</strong>: The <em>Application Setting</em> defaults to the FDA MedWatch 3500A version that your Vault currently exports. You can update this value as needed. To continue using the same version, you do not need to take any action.</p>
    </div>
  </div>
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### Update the Product Layout

To support the September 2025 version of the FDA MedWatch 3500A form, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _FEI Number_ field to applicable _Product_ object layouts.

[1]: #r262