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US Medtech Urges Caution To Growing Push For 'Real-World' Device Evaluation System

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration is stepping up efforts to develop and launch a new 'national evaluation system' for medical devices that relies on shared-access registries, claims data, health records and other electronic data, but industry advocates are cautioning against moving too fast. Companies worry about unintended consequences and say more details are needed on how the broad-based initiative to expand availability of "real-world" evidence for devices will impact the medtech innovation cycle.

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