FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions


On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”).

Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by Section 1136 of the July 2012 FDC Act amendments known as the Food and Drug Administration Safety and Innovation Act (FDASIA), requires that most medical device submissions include an eCopy of the submission upon issuance of a final guidance document by FDA. That requirement took effect on January 2, 2013. An eCopy is an electronic copy and not a submission that is submitted electronically. It is an exact duplicate of the paper submission that is provided to FDA on a compact disc (CD), a digital video disc (DVD), or a flash drive, except that the eCopy may include information that cannot reasonably be provided on paper. According to the eCopy guidance, “[t]he critical attribute of an eCopy is that it must include in electronic form all data required for that submission type. In other words, the eCopy must include all of the required information for FDA review, whereas the paper copy can include a placeholder cross-referencing the location of certain information in the eCopy.” The eCopy guidance describes the requirements regarding eCopies, including the specific naming and formatting conventions that must be used for FDA to accept them. The inclusion of an eCopy in almost all types of medical device submissions is expected to make the review process more efficient.

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