Requirements Document_CDRH-2026-132746-08.21.2026.pdf

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Requirements Document: Micro-Focus X-Ray Tube System (CDRH-2026-132746)

U.S. Food and Drug Administration Requirements Document

Micro-Focus X-Ray Tube System for Phase Contrast Imaging Research Date: 08.19.2026

1. Purpose

This document states the requirements for the acquisition of one (1) micro-focus X-ray tube system for phase contrast imaging research. The acquisition is for commercial supplies delivered to an FDA location.

2. Background

The Office of Science and Engineering Laboratories (OSEL), Division of Imaging, Diagnostics, and Software Reliability (DIDSR) within the U.S. Food and Drug Administration (FDA) requires a micro-focus X-ray tube system to support development of a benchtop phase contrast imaging system and associated image quality assessment methods for evaluation of emerging breast imaging technologies.

This requirement supports CDRH Strategic Priorities by providing DIDSR researchers with technical skill development opportunities; advancing CDRH’s Simplicity initiative by improving pathways for evaluating emerging technologies; and supporting the development of high-quality, safe, and effective medical imaging technologies to improve patient outcomes. This procurement will also support the OSEL mission by accelerating research on advanced breast imaging technologies.

3. Scope

This acquisition is for the supply of the items identified in Section 4, in the quantity stated in Section 5, delivered and accepted per Sections 6 through 8.

This acquisition does not include installation of the delivered items.

4. Salient Characteristics and Minimum Specifications

All items shall be new and unused. Items shall not be used, refurbished, reconditioned, remanufactured, previously opened, expired, or beyond the manufacturer's shelf-life dating at the time of delivery.

Salient characteristics and any single-source need The supplies shall meet the following salient characteristics and minimum specifications:

• Focal spot size: a system offering a 5 micron focal spot size.

• Power capability: minimum 15 Watts.

• X-ray tube voltage range: 20-100 V.

• X-ray tube current range: 0-375 mA @ 40-100V.

• Integrated high voltage supply.

• External control via RS-232C interface.

• Control software included, with control software documentation and operating documentation delivered with the system.

• Suitable for X-ray CT and propagation-based phase contrast imaging applications.

Not Applicable. This is a performance-based, full-specification requirement; no specific make or model is required. Per source SOW: “References to system characteristics are performance-based requirements and are not intended to restrict competition.”

Requirements Document: Micro-Focus X-Ray Tube System (CDRH-2026-132746)

5. Quantity and Deliverables

The contractor shall furnish the following supplies in the quantities shown:

Item description Unit of issue

Quantity Delivery location Delivery frequency

Micro-focus X-ray tube system

Each 1 FDA White Oak Campus, Building 62, Room 3105, 10903 New Hampshire Avenue, Silver Spring, MD 20993

One-time

Quantity basis: One-time purchase; total quantity is one (1) micro-focus X-ray tube system.

6. Delivery Schedule and Delivery Terms

FOB point: Destination.

Delivery location(s): FDA White Oak Campus, Building 62, Room 3105, 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Delivery schedule: one shipment, delivered and installed within six (6) weeks of contract award.

Delivery dates are firm. The contractor shall not extend a delivery date without prior written approval of the Contracting Officer.

The contractor shall provide advance shipping notification and delivery status updates bi-weekly, with a minimum of one notification two weeks prior to delivery.

7. Packaging, Marking, and Shipping

Supplies shall be packaged in accordance with standard commercial practice, sufficient to ensure arrival at destination undamaged and in usable condition. Each shipment shall be marked with the contract or order number, item description, quantity, and destination.

8. Inspection and Acceptance

Inspection and acceptance shall be at destination. Consistent with RFO 46.202-1, the Government will rely on the contractor's existing quality assurance system for commercial products. Final acceptance is based on receipt of the correct items, in the correct quantity, conforming to the specifications in Section 4, in undamaged and usable condition.

For this acquisition, acceptance additionally requires verification that the system fully demonstrates basic operational functionality at the Government site. Final acceptance is made by the Contracting Officer’s Representative (COR) or a designated technical representative.

Nonconforming or damaged items shall be replaced at no additional cost to the Government within 6 weeks of notification.

9. Warranty

Consistent with RFO 12.105(b), the Government will accept the contractor's standard commercial warranty to the maximum extent practicable.

The delivered system shall include a one (1) year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of the contract.

Requirements Document: Micro-Focus X-Ray Tube System (CDRH-2026-132746)

No additional extended warranty or maintenance services are required beyond this warranty period.

10. Information Technology and Accessibility

State whether the item includes embedded or companion software, connects to an FDA network, or stores or transmits data: No. The system includes control software, but the control software operates the benchtop instrument only; it does not connect to an FDA network and does not store or transmit FDA data.

11. Period of Performance

The period of performance begins upon award. For a one-time acquisition, it continues through final delivery and acceptance of all items. For a recurring-delivery acquisition, it continues through the base period stated in the resulting contract, plus any option periods exercised.

Not Applicable. This is a one-time acquisition, not a recurring-delivery acquisition. The period of performance is six (6) weeks from the date of contract award, through final delivery, installation, and acceptance. No option periods apply.

12. Points of Contact

TBD