eCopy Program for Medical Device Submissions
An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or a flash drive. Including an eCopy with your submission has been required since January 1, 2013. A submission with an eCopy that does not meet the technical standards outlined in the eCopy guidance will be placed on eCopy hold until a valid eCopy is received.
The following resources will help you in understanding the eCopy program and how to successfully create and submit your eCopy:
- eCopy guidance
- How to Submit an eCopy - Instructional Video
- Frequently Asked Questions
- eSubmitter-eCopies Tool (a voluntary tool that formats your eCopy content and allows you to download onto a local drive)
- eCopies Validation Module (a voluntary tool that verifies the format of an eCopy you have already developed on your local drive)
If you have questions about the eCopy program, please contact the eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.