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.

Download the Guidance below or here

Your Name

Enter Your Email to Download (Required)

eCopy Program for Medical Device Submissions
Tagged on: