RFQ_CDRH-2026-133668_Flat Panel Detector.docx

ALP: CDRH-2026-133668

Flat Panel Detectors

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number CDRH-2026-133668 is issued as an RFQ for Flat Panel Detectors.

This acquisition is not set-aside for small business concerns.

NAICS Code: 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing Small Business Size Standard: 1,000 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a quotation which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: 10903 NEW HAMPSHIRE AVE, BLDG 62, RM 3247, Silver Spring, MD 20993 FOB Point: Destination Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 60 days of award. The delivered items 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 this contract.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Contracting Officer:

Name: Maria Finan Email: Linda.Finan@fda.hhs.gov Phone: 240-402-5712 Contract Specialist:

Name: Freshta Javid Email: Freshta.Javid@fda.hhs.gov Phone: 301-796-0385

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SPECIFICATIONS

The Government requires the procurement of one (1) large-area 2D X-ray flat panel detector to support laboratory cone-beam CT (CBCT) and fluoroscopy imaging for human-sized phantom development, testing, and validation of imaging evaluation methods at the FDA Center for Devices and Radiological Health (CDRH). The detector must meet all minimum performance specifications below:

A) Geometry / sampling

1. Active imaging area (minimum): ≥ 42.7 cm × 42.7 cm

2. Pixel pitch (maximum): ≤ 170 μm B) Image quality (minimum, measured under comparable conditions such as RQA5 or vendor’s equivalent)

3. MTF: ≥ 50% at 1 lp/mm (at full-resolution mode)

4. DQE: ≥ 70% at 0 lp/mm (quantum-limited or vendor equivalent definition)

5. Lag: ≤ 3% (first frame)

6. Fill factor: ≥ 60%

7. Maximum entrance dose per frame (typical): ≥ capability for 50 μGy/frame (or better, i.e., requiring less dose for equivalent image quality) C) X-ray operating range and performance

8. Energy range compatibility: 40–150 kVp (or wider) D) Frame rate / acquisition modes (minimum capabilities) 9.Fluoroscopy mode: ≥ 25 fps at approximately 3x3 binning (or equivalent), with large FOV support 10.Fluoro zoom mode (if offered): ≥ 30 fps at approximately 2x2 binning 11.CBCT projection mode: ≥ 40 fps at approximately 4x4 binning 12.Radiography (full resolution) mode: ≥ 4 fps E) Environmental, mechanical, cooling, and robustness 13.Cooling: Air cooling (no liquid cooling requirement) 14.Operating temperature limit: 19–49°C (or wider) 15.Relative humidity: 10–90% non-condensing (or wider) 16.Atmospheric pressure: 70–106 kPa (or wider) 17.Radiation tolerance: ≥ 2000 Gy (active area) or better 18.Weight: ≤ 15 kg (or lighter)

19. User/installation documentation and technical specifications in PDF format (hard copy if available).

20.Technical support: Minimum 1-year technical support (remote support required;

optional onsite support may be offered as a separately priced line item).

21. One (1) year manufacturer warranty.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.

A2. Addenda to 52.212-1

Offer Acceptance Period:

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice by July 1, 2026, 10:00 AM EASTERN TIME. Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit: 10 Pages

Offerors Shall Submit:

1. Technical quotation

1. Price quotation (inclusive of all CLINS)

1. Manufacturer’s product data sheet or technical brochure

1. Warranty terms

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Country of origin for all items

Points of Contact As listed on the SAM.gov notice.

C. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

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