Wearable Devices and Regulatory Decisions: ePRO Recommendations

Wearable technology offers powerful data collection capabilities for clinical studies, but requires careful consideration to meet regulatory standards.

This guide provides a structured approach to selecting and implementing wearable devices for regulatory decision-making and labeling claims.

You'll get an outline of essential evidence requirements to demonstrate your wearable's validity, including content validity, reliability assessment, concurrent validity, and ability to detect meaningful change. 

Learn how to evaluate device suitability across safety profiles, patient population considerations, and vendor characteristics to select technologies that deliver precise, reliable measurements of your endpoints of interest.