Combined Synopsis-Solicitation CDRH-OSEL-26-C-D718 PR-1050.pdf

U.S. FOOD AND DRUG ADMINISTRATION

Office of Acquisitions and Grants Services (OAGS) / Division DAP / Branch FSB

COMBINED SYNOPSIS/SOLICITATION

Commercial Products - FAR Subpart 12.6 (FAR 12.603) - Request for Quotations

Solicitation Number CDRH-OSEL-26-C-D718 Reference No. ALP: CDRH-2026-135348 Title Benchtop Spectroradiometer System with Flexible Microscope Probes and

Software Development Kit (SDK) Issuing Office FDA / OAGS / Division DAP / Branch FSB Contracting Officer James Jenrette (Contract Specialist & Contracting Officer), james.jenretteiii@fda.hhs.gov Requiring Activity CDRH / OSEL / DALS - Silver Spring, MD (White Oak) NAICS / Size Standard 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant

Wholesalers (200 employees) PSC 6650 - Optical Instruments, Test Equipment, Components and Accessories Set-Aside None - unrestricted; full and open competition (Determination Not to Set

Aside on file, FAR 19.502-2(a)) Order Type Single firm-fixed-price (FFP) purchase order - commercial product (FAR Parts

12 and 13) Issue Date July 22, 2026 Questions Due July 24, 2026, 12:00 PM ET (email to the Contracting Officer) Quotes Due July 29, 2026, 12:00 PM ET (email to james.jenretteiii@fda.hhs.gov) Anticipated Award On or about August 1, 2026 Evaluation Lowest-Priced Technically Acceptable (LPTA) Delivery Within 60 days after award, FOB Destination, Silver Spring, MD

1. COMBINED SYNOPSIS/SOLICITATION

(i) This is a combined synopsis/solicitation for commercial products 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; quotations are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is CDRH-OSEL-26-C-D718 and is issued as a Request for Quotations (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through the most current Federal Acquisition Circular.

(iv) This acquisition is unrestricted (full and open competition). The associated NAICS code is 423450 with a small business size standard of 200 employees. The estimated value is below the Simplified

Acquisition Threshold; simplified acquisition procedures under FAR Part 13 apply.

2. DESCRIPTION OF REQUIREMENT / SCHEDULE OF ITEMS

The FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering

Laboratories (OSEL), requires a high-precision benchtop spectroradiometer system for acquiring spectral data from a microscope, in support of color-performance evaluation methods and regulatory-science tools for digital pathology. The system must meet or exceed every minimum performance requirement / salient characteristic in the attached Statement of Work (SOW). All items shall be new and non-refurbished, calibrated prior to delivery with a calibration certificate or test reports, and covered by a minimum one (1) year warranty.

CLIN Description Qty Unit Total Price 0001 Benchtop spectroradiometer meeting all SOW Item 1 salient characteristics (wavelength range at least 380-780 nm; back-thinned cooled CCD, at least 512 elements; spectral bandwidth < 5 nm; wavelength accuracy < 0.5 nm; luminance accuracy +/- 3%;

color accuracy (x,y) < +/- 0.002; variable internal apertures 2, 1, and 0.1-0.25 degrees; stray light < 0.06%; USB; 16-bit). Calibrated prior to delivery with certificate.

1 EA $________

0002 Flexible probes for measuring a light microscope per SOW Item 2 (4 ft or longer; designed for luminance and radiance measurements; 0.125 inch probe tip diameter).

1 LOT $________

0003 Fully documented Software Development Kit (SDK) per SOW Item 3 (instrument control, measurement, display/analysis, raw-data export to Excel/ASCII or equivalent; command-line support for third-party software such as Python or MATLAB; Windows 10 or later).

1 EA $________

Pricing shall be all-inclusive and firm-fixed-price: equipment, probes, SDK, software support, calibration and certificate, all shipping and handling to destination, any applicable tariff or surcharge lines (identified separately), and warranty. FOB Destination.

3. DELIVERY

• Delivery: within sixty (60) days after award, FOB Destination.

• Ship to: U.S. Food & Drug Administration, 10903 New Hampshire Ave, WO62-3133, Silver Spring, MD

20993-0002.

• All deliverables shall be marked with the contract number and contractor name, and delivered new, in usable and acceptable condition, per the SOW.

• The work is expected to be complete in the first year; the period of performance runs through the end of the warranty period.

4. PROVISIONS AND CLAUSES

• FAR 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services, applies to this acquisition, with quote-content addenda per Section 5 below.

• Evaluation will be Lowest-Priced Technically Acceptable as described in Section 6; the Government intends to award without discussions.

• FAR 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial

Services: quoters shall have completed annual representations and certifications current in

SAM.gov.

• FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services, applies to any resulting award.

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -

Commercial Products and Commercial Services, applies to any resulting award, including the clauses applicable at this dollar value.

• Quoters must be actively registered in SAM.gov (with no active exclusions) to be eligible for award.

5. INSTRUCTIONS TO QUOTERS

Quotes shall be submitted by email to james.jenretteiii@fda.hhs.gov no later than July 29, 2026, 12:00

PM ET, and shall include:

• Itemized firm-fixed pricing for CLINs 0001-0003, all-inclusive with shipping and handling; any tariff or surcharge amounts identified as separate line entries.

• A point-by-point statement of compliance against each salient characteristic in the SOW (Items 1-3), with descriptive literature or specifications sufficient to verify compliance.

• Confirmation of delivery within 60 days after award to the Silver Spring, MD destination.

• Warranty terms (minimum 1 year) and a description of recalibration support (at the supplier facility or on-site at FDA).

• Company information: UEI, CAGE code, business size under NAICS 423450, and confirmation of active SAM.gov registration.

• Quote validity: quotes shall remain valid for a minimum of sixty (60) days.

• Questions are due by July 24, 2026, 12:00 PM ET by email to the Contracting Officer; answers will be provided to all known interested sources and posted as an amendment to the SAM.gov notice if material.

6. EVALUATION AND AWARD

The Government intends to award a single firm-fixed-price purchase order to the responsible quoter whose quote is the Lowest-Priced Technically Acceptable (LPTA), evaluated as follows:

• Technical acceptability: the quoted system, probes, and SDK meet or exceed every salient characteristic in the SOW, as demonstrated by the point-by-point compliance statement and supporting literature.

• Delivery: within 60 days after award.

• Price: lowest total evaluated price (CLINs 0001-0003) among technically acceptable quotes. Price reasonableness is anticipated to be established through adequate price competition (FAR 13.106-3).

The Government may award without discussions and reserves the right to cancel this solicitation at any time with no obligation.

7. INVOICING

The contractor shall submit invoices through the Invoice Processing Platform (IPP) in accordance with proper invoicing procedures under 48 CFR 32.905.

8. ATTACHMENTS

• Attachment 1 - Statement of Work: CDRH-OSEL-26-C-D718, Benchtop Spectroradiometer System with Flexible Microscope Probes and Software Development Kit (SDK), including Salient

Characteristics (Items 1-3) and General Requirements.