Electronic Copies (eCopies)
At this time, electronic copy (eCopy) requirements are in place. Section 745A(b) of the FD&C Act, added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA), provides statutory authority to require an eCopy for certain device submissions after issuance of a final guidance (See Public Law No: 112-144). Refer to the final guidance entitled eCopy Program for Medical Device Submissions for details, including the technical specifications/standards for eCopies.
FDA's eSubmitter now has a new tool that can be used to assist applicants in creating eCopies. The eCopies tool was made available for free for voluntary use by applicants. The tool creates an eCopy that is consistent with the technical specifications/standards.
For the first time use of this new tool, visit the Download and Installationwebpage, which allows you to download the eSubmitter software. Although that webpage offers links to download a manual and quick guide, these documents are generic to eSubmitter and much of that information does not apply to eCopies. Instead, refer to the quick reference guide below.