The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “eCopy Program for Medical Device Submissions.” The purpose of the guidance is to explain the new electronic copy (eCopy) Program for medical device submissions, which
is intended 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. The guidance describes how FDA has implemented the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance also provides the standards for a valid eCopy under the FD&C Act and identifies the
submission types that must include an eCopy in accordance with these standards for the submission to be processed and accepted for review by FDA. This final guidance will be considered in effect on January 1, 2013, or at the time of publication, whichever is later.


Posted on the FDA website on 3 January 2013