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.