On December 31, 2012 the guidance, “eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff" was issued as an official guidance document.  The guidance provides step-by-step instructions on how to make submissions for medical devices to FDA using the new eCopy format.  Yet to anyone attempting to issue a submission to FDA after January 1st utilizing a strictly paper format, it was quickly learned that this wasn’t a typical FDA guidance document.  FDA responded to those “paper only” submissions with an eCopy hold notification; in essence, not received.