Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

The FDA is working toward modernizing its framework for advancing the promise of digital health tools. Scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision-making.

In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.

Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

4 Key Principles of Digital Biomarker Development eBook Read it Today!

Kate Lyden, PhD

Kate Lyden, PhD

Kate Lyden, PhD, VivoSense Chief Science Officer, holds degrees in Kinesiology and Applied Physiology and has extensive research experience developing, validating, and using wearable sensors.

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