chapter  16
14 Pages

- 510(k) Reform: The Stakes Are High

The Food and Drug Administration’s (FDA’s) ability to implement its plan for rehabilitating the 510(k) process will directly affect the future of U.S. medical technology innovation and U.S. patients’ access to treatment. This theme is echoed by a number of industry experts, including AdvaMed’s David Nexon, senior executive vice president and head of policy, and Janet Trunzo, executive vice president for technology and regulatory affairs.* Nexon, who said AdvaMed was pleased with the way the implementation plan came out compared with the initial set of proposals, also said it was important to put the plan “in the context of American competitiveness and patient access.”