Implementing a national surveillance system would not be possible without the FDA’s establishment in recent years of a unique device identification (UDI) system, in which medical devices are marked on their labels with a unique code that can be used to track the device through its distribution and use in patients. These identifiers are stored in a public database, which now contains more than 1.5 million device records, that enables patients and health care providers to download information about their devices. Patient registries also utilize UDIs to help quickly identify safety signals tracked to specific devices.

We’ve also taken steps to advance the use of real-world evidence (RWE) in pre- and post-market decision-making. We believe that including the device identifier in electronic data more broadly, including in insurance claims, will advance FDA’s efforts to leverage real-world data to support the development of more effective post-market surveillance tools. A key element of implementing this strategy is the multi-stakeholder effort to establish the new national system for gathering real world evidence (NEST). Based on our early activities, we have evidence that NEST will help improve the breadth and quality of RWE we can access and analyze.


We’re now committing new resources to NEST to advance a more rapid build-out of this system.

In some cases, we already are receiving clinical evidence more quickly and more efficiently and are answering post-market questions we would not have been able to easily address in the past. NEST also will provide another source of information for medical device manufacturers to assess the safety and effectiveness of their devices and continue to develop innovative improvements. Importantly, it will help health care providers and patients stay better informed about the evolving benefit-risk profile of devices on the market and enable them to make more informed decisions.

NEST leverages a wide range of data systems that could provide crucial information on medical devices, including data from patient registries, Medicare claims and electronic medical records. Moreover, it was designed from the very beginning to serve as a resource for the entire community, which is why the Governing Board for NEST’s independently-run public-private coordinating center (called NESTcc) is comprised of members representing the key community stakeholders, including patients and providers.

Delivering on the goal to be first in the world to consistently identify and act on medical device safety signals will rest in part on our ability to fully leverage NEST as an active surveillance and evaluation system that complements the approaches currently in use by more quickly detecting emerging safety signals through active surveillance, supporting timely evaluation of these signals to determine if they represent a real risk to patients, and ensuring timely responses to new and increased risks.

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