Summary

The Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (US FDA) has undertaken work to refine its direction towards smart regulation, to protect public health by ensuring safe devices, and to promote public health by facilitating device innovation. This article reviews the updated mission, vision, and strategic plan for the CDRH, and its impact on regulatory science, clinical trials, feasibility trials, and pre- and postmarketing data.