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
- eCopy Validation Module (a voluntary tool that verifies the format of an eCopy you have already developed on your local drive)Important Note: The most recent validation modules were released on July 20, 2018. Please make sure you have downloaded the most recent version to ensure your eCopy is appropriately verified.
- 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)
A medical device submission package should be sent to the CDRH Document Control Center (DCC) at the following address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Hours of operation for DCC are 8:00 A.M. to 4:30 P.M. Monday through Friday, except for Federal Holidays.
If you have questions about the eCopy program, please contact the CDRH eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.
Information on sending regulatory submissions to CBER, such as the current mailing address for CBER’s DCC, can be found on CBER’s Regulatory Submissions – Electronic and Paper webpage.
If you have questions about regulatory submissions to CBER please contact them for further assistance at either 1-800-835-4709 or Industry.Biologics@fda.hhs.gov.