Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program-graysheet: FDA updated guidance on its eCopy program for medical device submissions Oct. 10 to clarify its proper usage to help companies submit electronic versions of device applications to the agency. The revised guidance (PDF) contains some substantive changes and adds clarifications and additional instructions to the previous final guidance issued on Dec. 31, 2012. Sponsors have been required to submit an eCopy of their submission along with a paper copy since Jan. 1, 2013, Peper Long, CDRH associate director for external relations, told “The Gray Sheet
