Sources_Sought_Vendor_Response_CDRH-2026-134082.xlsx

This is a Vendor Response Form for a Sources Sought Notice issued by the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) under Notice ID CDRH-2026-134082 for a 3D Particle Tracking Velocimetry (PTV) System. The requirement seeks a complete commercial system, including hardware and software, to support FDA research on non-clinical performance testing for Fractional Flow Reserve (FFR) software devices. The applicable NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 4.0. Under the preferred Integrated System approach, offered components must be fully compatible with specified Government-Furnished Equipment consisting of a LaVision camera, timing unit, lasers, and DaVis software. The system must be commercial equipment requiring no installation or training.

The form requires vendors to complete mandatory yellow-highlighted cells providing company information, UEI/CAGE code, point of contact details, active SAM.gov registration status, business size classification, and socioeconomic category eligibility (8(a), HUBZone, SDVOSB, VOSB, WOSB, EDWOSB, SDB). Respondents must also identify their role (manufacturer, distributor, reseller, or other), provide evidence of relevant experience through up to three recent contracts or commercial sales, identify applicable quality or regulatory certifications, and describe any teaming or subcontracting arrangements. All respondents must address domestic manufacture and availability, including country of origin, domestic content percentage, COTS status, production capacity against required quantities, and information on any critical components sourced from foreign suppliers. Small business respondents must additionally confirm their ability to supply end items manufactured by U.S. small business concerns consistent with the nonmanufacturer rule or clearly state if they would supply products from other than small or foreign manufacturers.