Description
The FDA is seeking a contractor to support a two-phase research initiative aimed at advancing the development, evaluation, and benchmarking of AI/ML-enabled wearable medical devices that monitor cardiac physiological signals. The contractor will conduct a systematic review and synthesis of publicly available cardiac physiological signal datasets and design and execute a prospective clinical study to collect, annotate, and deliver a comprehensive physiological dataset. The contractor will work in close collaboration with FDA subject matter experts and maintain regular technical engagement with the FDA.
• The contractor shall conduct a thorough review of publicly available datasets containing cardiac physiological signals.
• The contractor shall design and execute a prospective clinical study to collect, annotate, and deliver a comprehensive physiological dataset.
• The contractor shall ensure that all required equipment is available and appropriate for the activities listed in the study protocol.
• The contractor shall ensure that all specialized equipment necessary to support the study activities is procured and maintained in proper working order throughout the study.
• The contractor shall develop and maintain a study protocol document that includes observer training procedures, sensor placement specifications, signal synchronization procedures, quality-control checks, and procedures for handling protocol deviations or unusable data segments.