SaMD based cardiovascular diagnostic device (ppg and ecg wearables)

The Food and Drug Administration is forecasting a contractual engagement to partner with an external contractor for the development of benchmark reference datasets to support the validation and algorithm development of software as a medical device focused on cardiovascular diagnostics using photoplethysmography and electrocardiogram data from wearable technologies. The work will center on creating standardized datasets that serve as critical references for evaluating the accuracy, reliability, and performance of diagnostic algorithms, ensuring regulatory compliance and clinical readiness. This initiative is aligned with the NAICS code 541714 for research and development in the physical, engineering, and life sciences. The contract opportunity is posted under the FDA’s Center for Devices and Radiological Health, with the point of contact for program inquiries being the CDRH Acquisition Liaison at cdrhacquisitions@fda.hhs.gov. The contracting officer position is currently TBD, and the place of performance has not been specified. The forecast was published on May 25, 2026, and indicates a forthcoming opportunity for qualified vendors to respond, with no set-aside classification indicated at this stage. This effort is part of the FDA’s broader objective to advance the evaluation and approval of innovative wearable-based medical technologies through rigorous, data-driven validation frameworks.