Sparta Systems, Inc.


While e-submission of MDRs has been technically possible since late 2007, the lack of a mandate has slowed adoption of the platform. In addition, complexity in the formalized method for receiving acknowledgments from CDRH has made development of automated processing systems for eMDR challenging. Transitioning from a paper-based system to an electronic reporting platform will require thought, planning, design, testing, and implementation. The purpose of this paper is to help identify the issues which will emerge during the transition process with emphasis placed on careful up front thought and planning.