Update a submission

Once you have created a submission, you can add/remove files, edit the submission name, download the files included in the submission (with or without a pre-populated 2253 form), and update the submission status.

• Edit a submission name
• Add files to a submission
• Remove files from a submission
• Update a submission status
• Video: See the submission process in action

Edit a submission name

By default, submissions are named based on the date they were created. The name of a submission can be edited at any time prior to the submission being marked as Ready for dissemination. To update the name:

1. Open the submission you'd like to update.
2. Next to the name of the submission, click "Edit Name".
   
   
3. Update the text in the name field.
   
   
4. Click "Update".

Add files to a submission

1. Click "Add files" in the top right corner of the submission.
2. In the modal, select the checkboxes of the files you'd like to add to the submission.
3. Click "Add documents".

Remove files from a submission

1. Hover over the file you'd like to remove from the submission.
2. Click on the circle icon located to the left of the file name.
   
3. Once you have selected your file(s), click "Remove from submission".
   

Update a submission status

When you're ready, update the status of a submission from In submission prep to Submitted to the FDA, followed by Ready for dissemination.

Update from the individual submission page

1. Open the submission you'd like to update.
2. Click the "Status" dropdown and select the new status.
   
   

Update from the submission list

1. Click "Submissions" in the navigation.
2. Open the submission you'd like to update.
3. Click the "Status" dropdown and select the new status.
   

Video: See the submission process in action

Related help topics

• Create a submission
• Generate a 2253 form
• View submission information within the document details