Enable IMDRF on FDA MedWatch 3500A

Learn how to configure your Vault for exporting IMDRF codes to FDA MedWatch 3500A forms.

Last Updated

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About the Feature

Admins can now configure FDA MedWatch 3500A forms to export International Medical Device Regulators Forum (IMDRF) device codes instead of FDA device codes. The FDA is fully harmonized with IMDRF, and this change supports compliance with that regulatory push by the agency.

See FDA 3500A Generation Data Mapping for more information.

Configure the Submissions And Distributions Settings

To export IMDRF codes to FDA MedWatch 3500A forms, complete the following steps.

  1. Go to Admin > Settings > Submission And Distribution Settings.
  2. Select Edit and then select the Export IMDRF Codes on MedWatch 3500A checkbox.
  3. Select Save.