Electronic Delivery of Premarket Submissions Pilot
The FDA’s Center for Devices and Radiological Health (CDRH) is seeking volunteers to participate in the Electronic Delivery of Premarket Submissions Pilot (referred to later as “Pilot”), which provides a voluntary alternate method to submit a premarket medical device submission to CDRH for 90 days during the COVID-19 public health emergency.
For details, see Electronic Delivery of Premarket Submissions Pilot.
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. 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.
- Frequently Asked Questions
- eSubmitter-eCopies Tool (a voluntary tool that formats your eCopy content and allows you to download onto a local drive)
CDRH Document Control Center (DCC)
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.