eCopy Program for Medical Device Submissions

This is an updated version of the guidance that was issued on April 27, 2020. It provides clarifications to the eCopy Program related to its intersection with the eSTAR Program and the availability of the CDRH Portal, as well as minor updates to reflect modern technical standards (e.g., larger acceptable file size). This guidance provides information on the eCopy Program for medical device submissions. Section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA), requires that Pre-Submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, and any supplements to such Pre-Submissions or submissions, including appeals of those submissions, be submitted in solely in electronic format, beginning on such date as specified by the Food and Drug Administration (FDA) in final guidance. The eSTAR Program is the current program for submissions solely in electronic format. Until such time that eSTAR is implemented for each specified submission type, Section 745A(b)(1) identifies that Pre-Submissions or submissions for the submission types identified above must be submitted as electronic copies (eCopies). This guidance describes how FDA is implementing the eCopy Program under section 745A(b) of the FD&C Act.