This paper will summarize highlights of the safety approach and discuss the ITER EDA safety activities. The ITER safety approach is driven by three major objectives: (1) Enhancement or improvement of fusion's intrinsic safety characteristics to the maximum extent feasible, which includes a minimization of the dependence on dedicated “safety systems”; (2) Selection of conservative design parameters and development of a robust design to accommodate uncertainties in plasma physics as well as the lack of operational experience and data; and (3) Integration of engineered mitigation systems to enhance the safety assurance against potentially hazardous inventories in the device by deploying well-established “nuclear safety” approaches and methodologies tailored as appropriate for ITER.