www.fdanews.com/articles/159585-the-device-submission-ecopy-requirements
The Device Submission eCopy Requirements
November 5, 2013
Now that the eCopy program is well underway, it might be a good idea to review how the program works and consider a few of the common pitfalls. Although nearly a year has passed since the final guidance document for the eCopy Program for Medical Device Submissions was issued, the glitches are still being worked out.
FDA Law Blog
FDA Law Blog