USA – Guidance : eCopy Program for Medical Device Submissions

The purpose of this guidance is to explain the eCopy Program for medical device submissions. Section 745A(b) of the 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) with the issuance of this final guidance. This guidance describes how the Food and Drug Administration (FDA) is implementing the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.
This guidance provides, among other things, the standards for a valid eCopy under section
745A(b)(2)(A) of the FD&C Act. In accordance with section 745A(b), submission types
identified in this final guidance must include an eCopy in accordance with the standards
provided by this guidance for the submission to be processed and accepted for review by FDA, unless they have been identified as being exempted or waived. Submissions submitted without an eCopy and eCopy submissions that do not meet the standards provided in this guidance will be placed on hold until a valid eCopy is submitted to FDA and verified to meet the standards, unless a waiver or exemption has been granted. While the submission is on hold, the review will not begin and the submission will not be reviewed…