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. For more information, see FDA Report Formats.
Configure the Submissions And Distributions Settings
To export IMDRF codes to FDA MedWatch 3500A forms, complete the following steps.
- Go to Admin > Settings > Submission And Distribution Settings.
- Select Edit and then select the Export IMDRF Codes on MedWatch 3500A checkbox.
- Select Save.