The U.S. Food and Drug Administration is aggressively pursuing the creation of a national evaluation system for medical devices designed to generate better evidence for more efficient device evaluation and clinical/regulatory decision making.

As the cost of bringing new medical devices to market has become increasingly expensive and time-consuming, threatening to hamper innovation, FDA officials say the planned National Device Evaluation System (NDES) would help make safe and effective devices available to patients and their physicians more quickly as well as post-market information on which the agency can make more informed regulatory decisions. In particular, by leveraging real-world evidence, they contend that a national medical device evaluation system would strike the right balance between pre-market and post-market data collection.


Writing in a May 3 blog, FDA Commissioner Robert Califf, MD, argued that the task of evaluating drugs, biologics, or devices encompasses different data needs/methods. Yet, he made the case that all of them share a common attribute: the characterization of individuals and populations and their associated clinical outcomes after they have undergone diagnostic or prognostic testing or been exposed to a therapeutic intervention.

“When medical practice itself is part of the evaluation, characterization of the organization and function of delivery systems is critical,” Califf wrote. “In other words, the kinds of evidence needed to evaluate medical products for safety and effectiveness and the kinds of evidence needed to guide medical practice overlap substantially.”

At the heart of the NDES initiative are real-world data sources, including electronic health records, which the system would rely on to provide detailed data on medical devices and patient outcomes. A 2016-2017 strategic priority of the FDA’s Center for Devices and Radiological Health, agency officials envision the system linking and synthesizing data from different sources across the medical device landscape, including EHRs, clinical registries, medical billing claims, data transmitted from devices, and other digital sources.

“The evidence generated by this system would provide information on how devices operate in routine clinical practice and on a more diverse population than traditional studies,” says Deborah Kotz, an FDA press officer. “The system would also help reduce the time and cost it takes to perform studies that support medical device evaluation and to provide timely evidence to all stakeholders to support patient care.”

By the end of this year, the FDA hopes to gain access to 25 million electronic patient records from national and international clinical registries, claims data, and EHRs with device identification. That number is slated to quadruple by the end of 2017 to 100 million electronic patient records with device identification.

“These records are very important,” adds Kotz. “Electronic health records, as well as other electronic data captured at the time patient care is delivered, are critical to the success of the national evaluation system. FDA is working with hospitals and EHR vendors to capture unique device identifiers within health records to allow for detailed analyses.”

As FDA officials point out, the regulatory agency cannot build NDES on its own and needs support from industry to successfully establish the system. FDA’s CDRH is actively working with stakeholders, including medical societies, registries, academics, health systems, payers and other federal agencies, to help build the infrastructure, tools, and methods needed for the national evaluation system.

In particular, officials say the tools currently available for post-market surveillance of medical devices have limitations that would be improved with the new system.  With support from stakeholders, the agency hopes to establish an independent coordinating center for NDES by the end of this year.

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