SOLICITATION NOTICE
66 -- One (1) Heart Valve Accelerated Wear Durability Test System
- Notice Date
- 8/26/2025 9:09:20 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- RFQ-75F40125Q00362
- Response Due
- 9/8/2025 8:00:00 AM
- Archive Date
- 09/23/2025
- Point of Contact
- Sarah Hussain
- E-Mail Address
-
Sarah.Hussain@fda.hhs.gov
(Sarah.Hussain@fda.hhs.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/8bd9db5f25334a628c3f3c5b1df719fe/view)
- Place of Performance
- Address: Silver Spring, MD 20993, USA
- Zip Code: 20993
- Country: USA
- Zip Code: 20993
- Record
- SN07567504-F 20250828/250826230051 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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