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FDA Biological Sciences and Engineering Fellowship

*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available with the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration located in Silver Spring, Maryland.

Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental at the Center for Devices and Radiological Health (CDRH). The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Due to the non-physiological blood flow patterns generated by the blood-contacting medical devices and the exposure of patient blood to foreign materials, blood clot formation (or thrombosis) related complications frequently occur in patients, resulting in injury or death. To ensure patient safety, it is important to appropriately evaluate the blood compatibility of medical devices prior to clinical use. This project aims to develop and validate in vitro dynamic test methods that can be used to effectively and efficiently evaluate device thrombogenicity while reducing the need for in vivo animal studies. During this research project, the participant will receive broad biomedical research training in various aspects of engineering and biological testing. Under the guidance of a mentor, the participant will be involved in: 1) Performing benchtop experiments using human and animal blood to investigate the effects of key test parameters (anticoagulation, temperature, device geometry, etc.) on the sensitivity and effectiveness of an in vitro dynamic thrombogenicity test system; 2) characterizing the extent of device/material related thrombosis using various laboratory techniques such coagulation analysis, microscopy, and platelet activation assays; and 3) analyzing experimental results, perform statistical analyses, and summarize the test data.

If you have questions, send an email to ORISE.FDA.CDRH@orau.org. Please include the reference code for this opportunity (FDA-CDRH-2021-0006) in your email.