Plans for US Evaluation System for Medical Devices Take Root

Regulatory NewsRegulatory News | 14 January 2016 |  By 

The US Food and Drug Administration (FDA) is going to make a big push over the next two years to use more real-world evidence to track the safety of medical devices.

The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to leverage real-world evidence to more quickly identify safety signals, particularly through electronic health records (EHRs), registries and medical billing claims in which unique device identifiers (UDIs) are being used.

The system would also work in tandem with national resources such as PCORnet (EHRs), Sentinel (claims data), and national and international registries. Though FDA doesn’t delve too much into the details, the agency says the system would be developed through strategic alliances between disparate data sources and advancing UDI adoption, and operated by a public-private partnership and governed by a board of various stakeholder communities in the medical device industry, including government.

“Access to the 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,” FDA said.

The idea for the system, discussed in the center’s priorities plan for the last two years and highlighted in a report from 2012, comes as high costs and inefficient data generation in clinical trials have created disincentives for innovators to study their devices in the US. In addition, FDA said limitations of current postmarket surveillance tools, such as passive reporting, also constrain CDRH’s ability to rapidly address safety concerns.

Looking Ahead

As far as goals for the development of this system over the next two years, FDA says by the end of 2016, it expects to increase by 40% (compared to a 2015 baseline) the number of premarket and postmarket regulatory decisions using real-world evidence. And by the end of 2017, the agency expects to double (compared to 2015) that same number.

Resources permitting, FDA says it will look to establish an organizational structure and development of infrastructure for the National Evaluation System as envisioned in the report of the Engelberg Center for Health Care Reform Medical Device Postmarket Surveillance System Planning Board from February 2015 and the Medical Device Registry Task Force Report from August 2015.

The other two highlights of the agency’s strategic priorities plan deal with partnering further with patients on medical devices and promoting a culture of quality and organization.

2016-2017 Strategic Priorities Center for Devices and Radiological Health

CDRH 2014-2015 Strategic Priorities


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