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)
If you have questions about the eCopy program, please contact the eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.