TL15: Statistical Design and Analysis Challenges for Monitoring Devices
*Shanti V Gomatam, FDA/CDRH/DBS 


Monitoring devices can be defined as devices that are used to repeatedly examine patient condition to assess potential changes in status (that may dictate changes in treatment). These repeated measurements can be either qualitative or quantitative. Types of devices include continuous monitors (for eg. blood glucose monitors, continuous blood pressure monitors, fetal monitors), event monitors (cardiovascular event monitors, seizure detection monitors etc.), and intermittent patient status monitors (tumor monitoring assays, mammograms etc.) Statistical design and analysis challenges for such devices will be the topic of discussion at this roundtable.