Federal Register Notice: FDA is making available a draft guidance entitled eCopy Program for Medical Device Submissions. It aims to explain the new electronic copy (eCopy) program for medical device submissions and how FDA plans to implement the eCopy program. 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. To download this guidance, click here. To view this notice, click here.