eCopy requirements were implemented on January 1, 2013. Refer to the eCopy guidance entitled eCopy Program for Medical Device Submissions for details, including the technical standards for eCopies.
To assist applicants in meeting eCopy requirements, FDA developed the eSubmitter-eCopies tool. It is a free tool, and its use is voluntary. The eSubmitter-eCopy tool creates an eCopy that is consistent with the technical standards described in the eCopy guidance. At the end of the process, you will be required to download the packaged eCopy to your local drive. Your eCopy will be saved within a folder with a large alphanumeric ID. Then follow the directions in the eCopy guidance for how to process your eCopy.
First time users to eSubmitter need to first install eSubmitter:
- Windows users: Download and Installation on the generic eSubmitter webpage. (Do NOT use any user manuals or quick guides on the generic eSubmitter webpage because they are generic to eSubmitter and do NOT apply to the eSubmitter-eCopies tool. Instead use the eSubmitter-eCopies Tool Quick Reference Guide below.)
- Macintosh users: Installation of eSubmitter on Macintosh Guide
eSubmitter-eCopies Tool Specific References:
- eSubmitter-eCopies Tool Quick Reference Guide
- Video Tutorials for eSubmitter-eCopies Tool
- eSubmitter Basics (MP4 Video - 28 MB)
- Creating a New eSubmitter eCopy Submission, Non-Volume Based (MP4 Video - 36 MB)
- Creating a New eSubmitter eCopy Submission, Volume Based (MP4 Video - 39 MB)
- Adding Non-PDF Files to an eSubmitter eCopy Submission via MISC FILES and/or STATISTICAL DATA Folders (MP4 Video - 21 MB)
- Revising a Packaged Submission (MP4 Video - 20 MB)
If you have any questions about these eSubmitter instructions, please contact firstname.lastname@example.org. If you have questions about the eCopy program, including the technical standards for an eCopy, please contact the eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.