Sources Sought Notice_CDRH-2026-135447.pdf

SOURCES SOUGHT NOTICE: Whole-Slide Imaging (WSI) Scanner System

NAICS: 334516 – Analytical Laboratory Instrument Manufacturing

SBA Size Standard: 1,000 employees

PSC: 6650 – Optical Instruments, Test Equipment, Components and Accessories

Place of Delivery: US FDA

10903 New Hampshire Ave

WO62-3133

Silver Spring, MD 20993-0002

Responses due: August 7, 2026, 12:00pm, EDT by email to Erika Crawford;

erika.crawford@fda.hhs.gov

1.0 PURPOSE AND DISCLAIMER

THIS IS A SOURCES SOUGHT NOTICE ONLY, issued for market research under RFO Part 10. It is not a solicitation and does not commit the Government to issue one. The Government will not pay any costs incurred in responding. Responses will not be returned, and respondents will not be notified of results. Not responding does not preclude participation in any future solicitation, which, if issued, will be posted to SAM.gov.

This notice has two purposes:

(1) to identify sources of any business size capable of supplying domestic end products meeting this requirement, in support of the Government's obligations under the Buy American statute and RFO Part 25; and

(2) to determine whether capable small business concerns, whether as manufacturer, OEM, authorized distributor, or reseller, exist in sufficient number to support a set-aside under RFO Part 19.

Responses will inform the acquisition strategy, including the set-aside decision and any domestic availability determination, and may be summarized in market research documentation posted publicly with a proposed nonavailability waiver, if applicable.

Do not submit proprietary pricing; mark any confidential business information clearly.

2.0 DESCRIPTION OF REQUIREMENT

The Government anticipates the purchase of one (1) Whole-Slide Imaging (WSI) Scanner System on a one-time basis.

All equipment shall be newly manufactured. Used, refurbished, reconditioned, remanufactured, or demonstration units are not acceptable.

mailto:erika.crawford@fda.hhs.gov

The Whole-Slide Imaging (WSI) Scanner System shall meet or exceed the following minimum technical requirements:

1. Slide Handling

• The system shall accommodate standard 1 in. × 3 in. glass microscope slides.

• The system shall include an automatic slide feeder capable of scanning a minimum of four (4) glass slides without user intervention.

2. Illumination

• The system shall include a bright-field imaging configuration with an integrated lamp and condenser.

3. Imaging Optics

• The system shall be equipped with either a 20× or 40× objective lens.

4. Scanning and Stage Movement

• The system shall provide motorized Z-axis focusing controlled by the system software. The autofocus mechanism and associated algorithms shall provide precise and accurate focusing.

• The system shall include a motorized XY stage controlled by the system software.

• The system shall scan an area of at least 1 in. × 2 in. on each glass slide.

5. Image Sensor

• The system shall include a high-quality, low-noise digital image sensor (camera) with excellent linearity and image uniformity.

• When operating with the 20× objective, the system shall provide an image resolution of 0.50 micrometers per pixel (µm/pixel) or better.

6. Image Acquisition Software

• The system shall include software for controlling the scanner and camera and for acquiring and processing image data.

7. Image Stitching Software

• The system shall include software capable of automatically stitching individual image tiles or stripes into a seamless whole-slide image.

8. Image File Format

• The system shall generate, or be capable of converting images to, industry-standard open file formats (e.g., TIFF) that are compatible with third-party image analysis software, including ImageJ.

• If proprietary image file formats are used, the Contractor shall provide documentation describing the file format and any required software for accessing the image data.

9. Image Viewing Software

• The system shall include software for viewing, navigating, and reviewing whole-slide images.

10. Data Storage

• The system shall include sufficient data storage to save scanned whole-slide image files.

11. Warranty

• The Contractor shall provide a minimum one (1) year manufacturer's warranty covering electrical, electronic, and wear-related components.

12. Delivery

• The WSI Scanner System shall be delivered within four (4) weeks after receipt of the purchase order.

3.0 INSTRUCTIONS TO RESPONDENTS

Responses shall be submitted by email to the point of contact identified in the SAM.gov posting no later than the response due date, with subject line

“Sources Sought Response - CDRH-2026-135447- [COMPANY NAME].”

A complete response consists of:

(a) The Vendor Response Form (Attachment 1), completed and returned in its NATIVE MICROSOFT EXCEL (.xlsx) FORMAT. Do not convert the form to PDF, scan it, or alter its structure. Name the file: [INSERT NOTICE ID] _CompanyName.xlsx; and

(b) A capability statement not exceeding 10 pages in PDF format providing narrative elaboration and supporting documentation as applicable (product literature, specification sheets, letters of supply or authorized distribution).

The Company Information fields in Section 4.0 and the questions in Sections 5.0 and

6.0 below are reproduced in the Vendor Response Form. The Government intends to consolidate and analyze market data directly from the returned forms; responses https://appian-dsc.fda.gov/suite/sites/acquisition-lifecycle-platform/page/my-work/record/7ZPYOtgDWma1HS2HGrJRBPSVwFtV2wwZR6mlFkXGS88h2R3E9uOUEB4GAtjH3iB4p3GpYxWBy6K1cnBk-3L5550rIb9XmMLb4goD1MbjS1VhDzRaY3eT0XQN0ycOHz-0it2T5Dhi5imsg/view/summary submitted without the completed form in native Excel format may not be fully considered in the Government’s analysis.

Telephone inquiries will not be accepted.

4.0 COMPANY INFORMATION (provide all of the following)

4.1. Company Name / Address:

4.2. UEI / CAGE Code:

4.3. Point of Contact (Name, Phone, Email):

4.4. Active SAM.gov Registration (Yes/No):

4.5. Business Size under the stated NAICS (Small / Other than Small):

4.6. Socioeconomic Categories (all that apply): 8(a); HUBZone; SDVOSB; VOSB;

WOSB; EDWOSB; SDB; None

4.7. Existing Contract Vehicles (FSS/MAS, GWAC, IDIQ/BPA):

5.0 SMALL BUSINESS CAPABILITY QUESTIONS

5.1. Identify your role for the required items: OEM, manufacturer, authorized distributor or dealer, reseller, or other (describe). If a distributor or reseller, identify the manufacturer(s) of the end items you would supply and provide evidence of authorized distribution, if available.

5.2. If you are a small business that is not the manufacturer of the end item, state whether you can supply end items manufactured by a small business concern in the United States, consistent with the nonmanufacturer rule (13 CFR 121.406), and identify that manufacturer if known. If you would supply the product of an other than small or foreign manufacturer, state this clearly.

5.3. Describe your capability and capacity to fulfill the full scope of this requirement, including the quantities and delivery timeframes in Section 2.0, and identify any portion you could not fulfill. Include relevant experience (up to three recent contracts or commercial sales) and any applicable quality or regulatory certifications. Federal experience is not required.

5.4. Describe any teaming, joint venture, or subcontracting arrangements you anticipate.

6.0 DOMESTIC MANUFACTURE AND AVAILABILITY QUESTIONS

All respondents shall answer, regardless of business size.

6.1 Identify the country (or countries) in which the offered end item is manufactured and the operations performed at each location.

6.2 If manufactured in the United States, state whether the item meets the domestic content threshold in effect under RFO 25.101 as of the anticipated award date, or the approximate domestic content percentage you can certify to. State whether the item is a commercially available off-the-shelf (COTS) item and whether it consists wholly or predominantly of iron or steel.

6.3 Identify the country of origin of any critical components or components for which no domestic source is known to you.

6.4 If you can supply a domestic end product, describe production capacity for the quantity identified in Section 2.0 (available inventory, sustainable production capacity, and lead times). If you can satisfy the requirement only in part or with deviations from the salient characteristics, describe the shortfall specifically.

6.5 If you do not currently manufacture a domestic end product meeting this requirement, state whether and under what conditions you could establish or expand domestic production (estimated timeline, minimum quantities, or other commitments required).

6.6 Identify any alternative or substitute items manufactured in the United States that could satisfy the Section 2.0 characteristics, including items made by other firms, and identify any other known domestic manufacturers or supply chain constraints relevant to domestic availability.

6.7 If the offered item is not a domestic end product, identify its country of origin and, if known, whether it is a designated country end product under applicable trade agreements.