CDRH to Leverage More ‘Real-World’ Data in Decision Making

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) wants to increase the number of pre- and postmarket regulatory decisions that leverage real-world evidence by 40 percent by the end of this year and 100 percent by the end of 2017.
 
CDRH set out its plans for achieving this goal in its Strategic Priorities report for 2016-2017. According to the center, to successfully harness “the vast amount of information and knowledge created every day as a part of routine healthcare or generated at home” in an efficient manner, the agency must develop the necessary infrastructure—a national evaluation system for medical devices.
 
This system, first described in 2012, is intended to utilize information gathered from electronic health records (EHRs) and medical billing claims and would integrate other national resources, such as the National Patient-Centered Clinical Research Network or PCORnet, Sentinel (claims data), and national and international registries, according to the report.
 
The push to develop this system comes at a time when high costs and inefficient data generation in clinical trials are discouraging innovators from testing their devices in the United States, according to the FDA. In addition, the agency said that the limitations of current postmarket surveillance tools, such as passive reporting, constrain CDRH’s ability to rapidly address safety concerns.
 
“Through our priority to establish a national evaluation system for medical devices, we take a significant step to create a national safety net to protect patients and incentivize innovators to study their technologies in and ultimately bring their products to patients in the U.S. first,” CDRH wrote in its report. “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.”
 
To that end, CDRH intends to gain access to 25 million electronic patient records from national and international clinical registries, claims data, and EHRs with device identification by the end of this year and increase that to 100 million by the end of next year.
 
Resources permitting, the FDA says it will look to establish an organizational structure and develop the infrastructure for the evaluation system as envisioned by the Engelberg Center for Health Care Reform at the Brookings Institution and the Medical Device Registry Task Force.
 
CDRH also outlined its two other priorities for 2016-2017: partnering with patients to advance the development and evaluation of medical devices and to monitor their postmarket performance, and promoting a culture of quality and organizational excellence within CDRH and industry.