Landscape Analysis of Digital Health Technology Use for Remote Data Acquisition in CDER-Regulated Submissions,...

Digital health technologies can support remote acquisition of clinical investigation data and may facilitate more flexible clinical trial designs. In March 2023, FDA revised Forms FDA 1571 and FDA 356h to include a structured yes/no field asking whether a submission contains DHT data or a proposal to collect DHT data. This change created a mechanism for identifying submissions involving DHT-based remote data acquisition. Following implementation of these fields, the Office of Medical Policy in FDA's Center for Drug Evaluation and Research developed and implemented a systematic process to track, identify, and adjudicate DHT-related submissions. This analytical report presents a descriptive, aggregated, de-identified analysis of submissions that were flagged through this operational process from March 2023 through December 2025. Operational inclusion criteria were applied to identify submissions involving DHTs used for remote data acquisition intended to support regulatory decision-making. Of 2318 flagged submissions, 277 (12%) were confirmed for inclusion in this analysis. Confirmed submissions were predominantly associated with investigational applications (237/277, 86%). When classified by the nature of data collected, submissions reflected a range of remote data acquisition approaches, including patient reported data and sensor-based measurements, with some submissions combining more than one modality. Electronic diary and electronic patient-reported outcomes were most common, exclusively appearing in 161 submissions (58%), followed by data captured from general objective sensors in 92 submissions (33%) and continuous glucose monitoring data in 24 submissions (9%). These findings establish a quantitative baseline for DHT-based remote data acquisition in CDER submissions and the implementation of FDA's corresponding guidance.