Animal Whole Blood for Blood Compatibility Testing
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $10,000 to $25,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 111332 Grape Vineyards
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The FDA's Center for Devices and Radiological Health is procuring animal whole blood from healthy live donors for hemocompatibility research supporting medical device safety evaluation, with solicitation release estimated for June 1, 2027 and award targeted for September 1, 2027. The blood products will support multiple projects including in vitro blood flow loop thrombogenicity studies, dynamic hemolysis flow loop testing, and pulsed field ablation research, with the objective of developing regulatory science tools that reduce dependency on in vivo animal testing while improving FDA review efficiency for blood-contacting medical devices.
The estimated award value ranges from $10,000 to $25,000. Work will be performed by the Cardiovascular Program within the Division of Applied Mechanics, Office of Science and Engineering Laboratories at CDRH. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
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.
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