FDA Accepts Wearable Sensor-Derived Foot Drop Metrics Under ISTAND as Longitudinal Outcome Measures in Rare Neurological Condition

The Food and Drug Administration’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) for a wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adult patients with Charcot-Marie-Tooth disease type 1A (CMT1A), a progressive, degenerative disease. This LOI represents the first submission to be accepted into the ISTAND program for a digital health technology (DHT) for a rare neurological condition.