RT Journal Article
SR Electronic
A1 Mosley, Mary
T1 System Changes to Ensure Patient Safety and Access to Innovative Devices
JF MD Conference Express
YR 2013
FD SAGE Publications
VO 13
IS 19
SP 32
OP 33
DO 10.1177/155989771319017
UL http://mdc.sagepub.com/content/13/19/32.2.abstract
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.