To better need your eCopy needs, the FDA has updated our eCopy Program for Medical Device Submissions webpage to include additional resources.
In January 2013, the FDA developed the eSubmitter-eCopies Tool to assist applicants in meeting electronic copy (eCopy) requirements. The tool is free and its use is voluntary. We have posted five new video tutorials to supplement the existing Quick Reference Guide. The videos explain how to successfully create an eCopy in real-time using this tool.
We have also added a brand new tool for industry called the eCopies Validation Module. The eCopies Validation Module is a free and voluntary tool that allows you to confirm that the eCopy you created meets the requirements. After you download the tool, you choose the location of your eCopy and then run the tool. If your eCopy does not meet the eCopy requirements, the tool will display the reason(s) why. This will allow you the opportunity to address all eCopy issues prior to submitting it as part of your submission package to the CDRH Document Control Center (DCC).
As a reminder, all eCopies must be submitted on a CD, DVD, or flash drive and included as part of the submission package sent to the CDRH DCC. There is currently no option to submit online or via the FDA Gateway.
If you have any questions any questions about the updates, or about the eCopy program, please contact the eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.