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U.S. Department of Health and Human Services

Medical Devices

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Electronic Copies for Premarket Submissions

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), requires the submission of electronic copies (eCopies) for most premarket submissions. An eCopy is defined as an exact duplicate of a paper submission that is created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive.  It is not an electronic submission.

FDA's final guidance, eCopy Program for Medical Device Submissions, describes FDA's eCopy Program, the submissions for which eCopy requirements apply, the criteria FDA uses in assessing administrative completeness, and the technical standards for producing valid eCopies.

Beginning January 1, 2013, the FDA will only place a premarket submission under review if it has an eCopy that has been validated by FDA's eCopy loading system. 

In order to create an eCopy that is consistent with the technical standards, the FDA encourages applicants to use the free eSubmitter-eCopies tool.

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