In the first of three published strategic prioritiesfor 2016-2017, CDRH said itneeds a national medical device evaluation system that will “build upon and leverage the vast amount of information and knowledge created every day as a part of routine health care or generated at home, such as patients using monitoring devices—what we call ‘real-world evidence.’”
It said that having access to large amounts of electronic clinical data being generated and collected today “can be used to identify safety signals and support risk-benefit analyses when data quality is ensured and advanced analytics are applied. Real-world evidence in the future will be able to support regulatory decision making across the pre- and post-market continuum. To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI) are routinely incorporated into electronic health information.”
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