For mobile technology, validation ensures that the mobile technology is reliably
capturing, transmitting, and recording data to produce accurate, reliable, and complete
records. For example, if a wearable biosensor detects a blood glucose level of 87
milligrams per deciliter, the validation should ensure that the value is correctly and
reliably captured, transmitted, and recorded in the sponsor’s EDC system. Sponsors
should validate the mobile technology before use in the clinical investigation. In
addition, sponsors should ensure that device and software updates do not affect the
reliability of the data that enter the sponsor’s EDC system.
Part 11 regulations do not address the performance of wearable biosensors, mobile apps,
or portable devices (i.e., the ability to measure what they are designed to measure). For
example, validation does not apply to the ability of an activity tracker to accurately and
reliably measure the number of steps walked. Although performance of the mobile
technology is critical to the clinical investigation, recommendations for the performance
of specific mobile technology designed to measure specific biomarkers or physical
activity are beyond the scope of this guidance. For mobile technology that meets the
definition of device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)), other regulations and policies may apply.
