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FDA Issues Draft Guidance On Real-World Evidence For Medical Devices

 
• By Brian Bossetta

The US FDA is clarifying how it evaluates real-world data when making regulatory decisions on medical devices.

Real World Data
• Source: Shutterstock

The Food and Drug Administration draft guidance published on 19 December explains how the agency determines if real-world data (RWD) is sufficient for generating real-world evidence (RWE) that can be used when making regulatory decisions on medical devices.

The document, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” expands recommendations to the 2017 guidance,...

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