CDRH Clinical Study Service Contract

The U.S. Food and Drug Administration (FDA) is seeking a contractor to provide clinical study services for the validation of a novel computational/benchtop framework for standardizing ECG signals. The contractor will be responsible for recruiting 150 subjects in the base year and 35 subjects in each option year, collecting ECG signals, and performing AI/ML-based signal analysis. The contractor must also prepare a retrospective dataset of at least 4,000 subjects with characteristics similar to those of the prospective data. The contract has a base year and four option years, with a total duration of five years. The contractor must have a demonstrated history of collaborating with federal institutions, conducting clinical studies, and working in the field of artificial intelligence and machine learning. • The contractor must recruit subjects who are prescribed a suitable non-ECG diagnostic test relevant as ground truth and ECG acquisition as part of their clinical care. • The contractor must collect ECG signals from standard electrode locations using FDA-approved, good quality, commercial disposable "wet" electrodes. • The contractor must provide a prospective dataset of fully de-identified concurrent 12-lead ECG and wearable ECG signals. • The contractor must provide a retrospective dataset of fully de-identified concurrent real 12-lead ECG and synthetic wearable ECG signals.