Animal Whole Blood for Blood Compatibility Testing

The Cardiovascular Program within the Division of Applied Mechanics (DAM), Office of Science and Engineering Laboratories (OSEL), which is a part of the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), would like to contract a company to supply high-quality animal whole blood from healthy live donors for research purposes. These products are necessary to perform multiple hemocompatibility related projects such as in vitro blood flow loop thrombogenicity studies, dynamic hemolysis flow loop project, and pulsed field ablation project. These blood products will enable the development of regulatory science tools for evaluating the hemocompatibility of medical devices in efforts to improve safety evaluations and provide alternate in vitro test methods that reduce dependency on in vivo animal testing. By providing less burdensome and effective in vitro test tools to facilitate device innovation and improve FDA review efficiency, these projects support CDRH's vision to bring high-quality, safe, and effective blood-contacting medical devices to US patients first in the world.