One (1) Heart Valve Accelerated Wear Durability Test System

The U.S. Food and Drug Administration's Center for Devices and Radiological Health is procuring one Heart Valve Accelerated Wear Durability Test System to support regulatory science research projects in their Cardiac Device Flow Laboratory. The system will be used to develop and standardize non-clinical test methods for evaluating the durability of peripheral and cardiac valve devices, enabling accelerated wear testing that assesses long-term durability and fatigue resistance before devices proceed to animal studies and human trials. Key technical requirements include six independent test chambers, at least 12 pressure transducers, temperature control capabilities, and the ability to test various valve types and sizes up to 40mm while meeting ISO 5840 standard requirements. The procurement will use a Lowest Price Technically Acceptable evaluation method with technical and price factors weighted approximately equally. Quotations are due September 8, 2025 by 11AM, with questions due by September 29, 2025, and vendors must submit separate technical and pricing volumes with the technical volume limited to 20 pages.

This opportunity is designated as a total small business set-aside under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 1,000 employees. The contract includes a 12-month warranty, remote training for five users, and an optional annual maintenance component, though specific award values or budget ranges are not disclosed in the solicitation materials. The procurement involves acquiring a single sophisticated test system that will directly support FDA's regulatory oversight responsibilities for cardiac and peripheral valve devices. Performance will take place in Silver Spring, Maryland, where the FDA's testing facilities are located. The solicitation allows a relatively short response timeframe of approximately two weeks from posting to submission deadline.