Combination Synopsis Solicitation.docx

COMBINED SYNOPSIS/SOLICITATION

Solicitation Number: 75F40125Q00424

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

This solicitation is issued as a Request for Quotation (RFQ) under solicitation number 75F40125Q00424. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC 2025-06).

1. Solicitation Information

· Solicitation Number: 75F40125Q00424

· NAICS Code: 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing

· PSC Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies

· Set-Aside: None. This procurement is unrestricted and open to all responsible sources.

· Type of Contract: Firm Fixed Price (FFP)

· Acquisition Method: FAR Parts 12 and 13 – Commercial Items and Simplified Acquisition Procedures

2. Description of Requirement The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires the purchase and delivery of a portable force plate system for gait and balance assessment to support biomechanics research in the Human-Device Interaction Lab.

3. Salient Characteristics / Technical Requirements The Government requires two (2) force plates and platform for gait analysis that meet the requirements in the attached Requirements Document.

4. Delivery Information

· Delivery Deadline: Within 60 calendar days of award

· Ship To:

FDA – CDRH

10903 New Hampshire Ave Building 62-1105 Silver Spring, MD 21140

5. Quote Submission Instructions Vendors must submit the following:

1. Firm Fixed Price Quote – inclusive of all items, shipping, and warranty

2. Technical Description (product literature/spec sheets) demonstrating compliance with all salient characteristics

3. UEI Number and Tax Identification Number (TIN)

4. Estimated Delivery Timeframe (must meet or exceed the 60-day delivery requirement)

5. Confirmation of SAM.gov Registration Quote Due Date: 09/16/2025 at 12:30 PM ET Submit quotes via email to: Jennifer.mun@fda.hhs.gov Subject Line: Quote Submission – RFQ 75F40125Q00424 – Force Plates and Platform Gait Analysis

6. Evaluation Criteria Award will be made to the Lowest Price Technically Acceptable (LPTA) offeror whose quote meets all of the required technical specifications. The Government reserves the right to award without discussions.

The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the initial offer should contain the offeror’s best terms.

7. Contract Clauses and Provisions The following FAR provisions and clauses apply to this acquisition and are incorporated by reference:

Provisions:

· FAR 52.212-1 – Instructions to Offerors—Commercial Items

· FAR 52.212-3 – Offeror Representations and Certifications—Commercial Items Clauses:

· FAR 52.212-4 – Contract Terms and Conditions—Commercial Items

· FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, including but not limited to:

· FAR 52.222-3, Convict Labor

· FAR 52.222-19, Child Labor—Cooperation with Authorities and Remedies

· FAR 52.222-21, Prohibition of Segregated Facilities

· FAR 52.222-26, Equal Opportunity

· FAR 52.225-1, Buy American—Supplies

· FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management Full text of FAR provisions and clauses may be found at: https://www.acquisition.gov

8. Point of Contact Contracting Officer: Jennifer Mun Agency: U.S. Food and Drug Administration Email: Jennifer.mun@fda.hhs.gov

9. Attachments The following documents are attached and made part of this solicitation:

· Attachment 1 – Requirements Document: Portable Force Plate System for Gait Analysis