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eCopy Program for Medical Device
Submissions
Guidance for Industry and Food
and Drug Administration Staff
Document issued on: October 10, 2013
This document supersedes the guidance of the same title dated
December 31, 2012.
For questions regarding this document, contact CDRH’s eCopy Program Coordinators at 240-
402-3717 or cdrh-eCopyinfo@ or CBER’s Office of Communication, Outreach and
Development, at 1-800-835-4709 or 301-827-1800.
U.S. Departmen
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