|Authors||Jeffrey Shuren, MD, JD; Robert M. Califf, MD|
|Link to article|
Conclusion A national evaluation system that engages all stakeholders could enable the FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations. When issues with medical technologies arise, they could potentially be quickly detected and understood within the appropriate context. Ultimately, these changes could contribute to a much more efficient system that rewards innovation that leads to better health outcomes, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.