An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For details on the eCopy program, including the technical standards for eCopies, refer to the eCopy guidance: eCopy Program for Medical Device Submissions.

Source: eCopy Program for Medical Device Submissions


Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.