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.

Although this feature is Auto-on, some components require additional configuration. After configuring this feature, see FDA 3500A Generation Data Mapping for more information about field mapping.

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 (Alt Text) 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 (app-control) 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.