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CONCLUSIONS In sum, a variety of sources of data beyond those from traditional clinical trials are used to generate evidence about the safety of marketed medicines. While many of these sources have been used for several decades, advances in the availability of largescale datasets and the development of sophisticated informatic and statistical techniques are changing the nature of postmarket safety analyses. Continued evolution of data and methods, informed by prior learnings, will contribute to more timely and robust safety surveillance and benefit– risk decision making.

Advances in the Use of Real‐World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology