PT  - JOURNAL ARTICLE
AU  - Mosley, Mary
TI  - System Changes to Ensure Patient Safety and Access to Innovative Devices
DP  - 2013  01
TA  - MD Conference Express
PG  - 32--33
VI  - 13
IP  - 19
4099  - http://mdc.sagepub.com/content/13/19/32.2.short
4100  - http://mdc.sagepub.com/content/13/19/32.2.full
AB  - 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.