Effective January 1, 2013, the U.S. Food and Drug Administration (FDA) will only review a premarket submission if it has an electronic copy (eCopy) that has been validated by FDA's eCopy loading system. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive.This means that 510(k)'s and applications for Premarket Approval (PMA's) which are not submitted to FDA in both hard copy and eCopy format will be rejected. An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission. The signed eCopy statement must say: THIS ECOPY IS AN EXACT DUPLICATE OF THE PAPER COPY.
*Not licensed to practice law in Florida.