One (1) Heart Valve Accelerated Wear Durability Test System


Subject: One (1) Heart Valve Accelerated Wear Durability Test System
Solicitation Number: RFQ-75F40125Q00362
Notice Type: SOLICIT
NAICS: 334516
Set-Aside: Total Small Business
Notice Published: 08-26-25
Response Due: 09-08-25

Agency: Department of Health and Human Services
Office: FOOD AND DRUG ADMINISTRATION
Contact: Sarah Hussain This email address is being protected from spambots. You need JavaScript enabled to view it.
Office Address: Beltsville, MD 20705
Place of Performance: Silver Spring, MD 20993


Click for official SAM (FBO) notice, additional information, and accompanying attachments

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), intends to purchase one (1) Heart Valve Accelerated Wear Durability Test System. This test system will be directly used in regulatory science research projects carried out by the Cardiac Device Flow Laboratory to develop and standardize non-clinical test methods for durability assessment of peripheral and cardiac valve devices. Accelerated wear testing is a critical pre-market regulatory test requirement to evaluate the long-term durability and fatigue resistance of valvular devices, ensuring they can withstand millions of cardiac/respiratory cycles safely and effectively before use in animal studies and human subject trials.