The Department of Health and Human Services Food and Drug Administration (FDA) is seeking an external contractor to develop benchmark reference datasets for validating and developing algorithms for a Software as a Medical Device (SaMD) based cardiovascular diagnostic device using photoplethysmography (PPG) and electrocardiogram (ECG) wearables. The project is classified under the Analytical Laboratory Instrument Manufacturing NAICS code 334516, with an estimated solicitation release date of February 1, 2026, and an anticipated contract award date of April 1, 2026. The primary objective is to support the development and validation of advanced cardiovascular diagnostic technology through comprehensive dataset creation.

While specific award values are not disclosed, the contract will involve collaboration with the FDA to create reference datasets critical for algorithm development and device validation. The point of contact for this opportunity is Joshua Holliday, who can be reached at joshua.holliday@fda.hhs.gov within the FDA organization. The forecasted contract appears to be open to all bidders, as no specific set-aside classification is noted, suggesting potential opportunities for various qualified analytical and medical technology firms interested in supporting advanced cardiovascular diagnostic device research.

SaMD based cardiovascular diagnostic device (ppg and ecg wearables)

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