U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. eCopy Program for Medical Device Submissions
  1. Device Advice: Comprehensive Regulatory Assistance

eCopy Program for Medical Device Submissions

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:

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.