Create a submission for FDA Form 2253

Create submissions in Vodori to help prepare 2253 submissions to the FDA. Submissions can include files from the system, their linked references, uploaded supported materials, and an auto-populated 2253 form.

1. Click "Submissions" in the navigation.
2. Click "Create submission." The number next to the button represents approved documents that should be submitted to the FDA, but have not yet been included in a submission. 
   
3. Select the checkbox next to the file(s) you’d like to include in your submission.
   
   
4. If applicable, check the options to include references and/or supporting materials that were uploaded in the Viewer.
5. Click "Start submission."

Vodori will take you to your submission, where you can make edits and download the 2253 form.

See the entire submission process in action:

Unzip files on Windows 10

The default unzipper on Windows 10 is unable to open documents with file names that contain extended or double-byte characters, like apostrophes. If you have trouble unzipping a submission, try using a different program, such as Winzip, 7-Zip, or ZipGenius, to open the zip file instead of the default unzip tool.

Related help topics

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