SSN-CDRH-2026-132857.docx

SOURCES SOUGHT NOTICE

TITLE: Automated MTS Load Cell Notice Number: SSN_ CDRH-2026-132857 THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING A RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is issuing this sources sought announcement on behalf of: Division of Applied Mechanics (DAM) Center for Devices and Radiological Health (CDRH).

a) identify vendors capable of providing the equipment and service as detailed in this notice, and

b) identify vendors capable of providing a domestic end product, as defined in FAR Part 25 (Buy American requirements), or identify if only foreign end products are available. Responses from small and other than small businesses are appreciated and accepted.

NAICS Code: 334516 – Analytical Laboratory Instrument Small Business Size Standard: 1,000 employees Background Division of Applied Mechanics (DAM) relies on the MTS Mini-Bionix 858 test system to perform high-quality benchtop mechanical testing of novel and innovative orthopaedic and cardiovascular medical devices under static and cyclic tension, compression, and torsion testing. This level of high-level testing requires the use of a high-resolution and high-capacity load sensing device. DAM requires access and continued uninterrupted use of the MTS Mini-Bionix load cell to maintain continuity of a number of ongoing FDA research projects supporting orthopedic and cardiovascular medical device evaluation for which significant effort has been invested to design custom fixtures and custom protocols that can only work with the MTS system and associated load cell. The Government requires a replacement load cell fully compatible with the existing MTS Mini-Bionix 858 testing system to avoid interruption of ongoing FDA research activities and to preserve compatibility with existing fixtures, test methods, software configurations, and validated laboratory procedures. This procurement is necessary to maintain continuity of critical medical device testing activities supporting CDRH research, standards development, and regulatory science initiatives.

This requirement shall be acquired using a Firm-Fixed-Price (FFP) commercial supply contract inclusive of delivery, installation, calibration, travel, labor, warranty, and all associated incidental costs.

Objective The overall objective of the requirement is to replace the existing malfunctioning load cell that is crucial to the operation of the MTS Mini-Bionix 858 system. This system is used extensively for satisfying performance goals for a multitude of projects in DAM. These projects span a wide range of fields including cardiovascular devices, lattice mechanics, orthopedic joint model validation, testing, and cyclic loading. It is essential to acquire this load cell to develop and continue to support FDA research, standards development, and regulatory science activities.

Scope of Requirement The contractor shall provide one (1) load cell transducer and all labor, materials, equipment, installation services, calibration services, interface hardware, travel, and incidental items necessary to provide a fully operational load measurement solution compatible with the Government-owned MTS Mini-Bionix 858 system. The MTS Mini-Bionix 858 system is identified as the reference platform for compatibility purposes only. Equivalent products meeting all stated salient characteristics and interoperability requirements will be considered.

Minimum Technical Requirements (Salient Characteristics) The following salient characteristics represent the Government's minimum requirements. Vendors responding to this Sources Sought Notice should identify whether their proposed product meets these requirements:

· Load cell transducer capable of measuring 0N to ±22,000N in tension and compression.

· Load cell transducer capable of measuring 0Nm to ±200Nm in torsion.

· Compatible with existing MTS controller hardware, software configuration, and data acquisition interfaces without requiring replacement of the existing MTS Mini-Bionix 858 system.

· Compatible with MTS Mini-Bionix 858 load frame model 662.20H-05

· Compatible with existing TDS connectors or provide a complete interface solution.

· Support load and torque reporting functionality.

· Include all required mounting hardware, interface plates, adapters, and accessories.

· Calibration shall be traceable to NIST standards and documented through calibration certificates.

· Include calibration certificates and warranty documentation.

Deliverables The contractor shall deliver one (1) load cell transducer within six (6) weeks after contract award (ARO). Installation shall be completed within five (5) business days after delivery. Calibration shall be performed at the time of installation. Calibration reports and calibration certificates shall be provided within five (5) business days following completion of calibration activities. An installation and operational verification report shall be provided upon completion of installation and successful operational testing. Warranty documentation shall be provided upon Government acceptance of the equipment.

Government acceptance will occur after successful installation, calibration, operational verification, and receipt of all required documentation.

The contractor shall arrange delivery of the equipment to the FDA White Oak Campus FDA White Oak Campus Building 62 Room G216 10903 New Hampshire Avenue Silver Spring, MD 20993 Requested Information from Vendors Please provide the following information:

- Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI)

- Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: MTS Load Cell

- What is your company size? If small, what is your socio-economic status?

- Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.

- Domestic manufacturing status.

- Technical specifications for the proposed solution.

- Identify the country of manufacture and country of origin of the proposed load cell and major components.

- Capability statement demonstrating the company's ability to provide the required product and associated installation/calibration services.

- Vendors shall state whether the proposed product qualifies as a domestic end product in accordance with FAR Part 25 (Buy American), identify the country of manufacture, country of origin, and identify the manufacturer. If the product does not qualify as a domestic end product, vendors shall identify the foreign country of origin.

-Confirm your ability to meet the Government's required delivery, installation, calibration, and operational verification schedule.

Small Business Capability Questions If your company is a small business concern, please address the following:

1. Is your company the manufacturer of the proposed load cell transducer? If not, identify the manufacturer.

2. Can your company provide a product meeting all minimum technical requirements identified in this notice?

3. Has your company previously provided similar load cells, testing equipment, installation services, or calibration services to Federal agencies or commercial laboratories? If so, provide a brief description.

4. Can your company provide delivery within six (6) weeks after award and complete installation, calibration, and operational verification within five (5) business days after delivery?

5. If applicable, identify your socioeconomic status (e.g., Small Business, 8(a), HUBZone, SDVOSB, WOSB, EDWOSB).

6. If your company is a reseller or distributor, identify the manufacturer and describe your relationship with the manufacturer.

7. If your company is offering an equivalent product, describe how the proposed product meets the Government's minimum requirements and interoperability requirements with the existing MTS Mini-Bionix 858 system.

8. Is the proposed product a domestic end product as defined by FAR Part 25? If yes, identify the manufacturer and manufacturing location. If no, identify the country of origin and manufacturer.

Disclaimer and Important Notes This is not a Request for Proposal (RFP) and does not commit the Government to award a contract. Responses will be used solely for market research. The FDA will not provide feedback or evaluations of submitted capabilities. Proprietary information should not be submitted.

Submission Instructions Responses are due by July 1, 2026 and shall be submitted via email to:

Name: Reagan Davis Contract Specialist Email: Reagan.Davis@fda.hhs.gov Subject: Sources Sought Notice Number: SSN_ CDRH-2026-132857

– MTS Load Cell