FDA Guidance for Industry
eCopy Program for Medical Device Submissions
Document issued on: October 10, 2013
An electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or a flash drive is called “An Electronic Copy (eCopy).”
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 by the FDA.