ARTICLE SUMMARY:
The National Evaluation System for health Technology Coordinating Center is accelerating efforts toward its vision of “NEST 2.0,” which will be the demonstration of a fully functioning real-world evidence system to support regulatory decision-making. NESTcc head Sandra Siami tells Market Pathways her goal is to reach that critical juncture within the year.
Real-world evidence (RWE) is playing an increasingly prominent role in the medtech arena. Registries, for instance, are commonplace in monitoring device safety and performance. RWE has also started to become a factor in premarket regulatory submissions, for both new products and labeling expansions. But the practice of leveraging registries, electronic health records (EHRs), and other tools that generate real-world data (RWD) to support regulatory decision-making is still very much in its infancy.
