Supplies_CSS__V2_2_260620.docx

ALP: CDRH-2026-134011

Short Description: Electrosurgical Unit

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. Quotations are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00277 is issued as a/an [☒ RFQ ☐ RFP ☐ IFB] for one (1) commercial Electrosurgical Unit (ESU) and all required accessories. The ESU will be used to generate electromagnetic disturbance signals that emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes. The acquisition includes all accessories necessary for full operation, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 30 calendar days after contract award. The equipment shall be new, unused, fully operational upon completion of required installation, and meet all technical and functional requirements specified in the Requirements Document. The anticipated quantity is one (1) complete system, including all accessories, documentation, and warranty required by the Requirements Document.

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

Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

NAICS Code: 339112 Surgical and Medical Instrument Manufacturing Small Business Size Standard: 1000 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 ☐ bid ☐ proposal, which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance:

White Oak Building 62 Room 1131 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 FOB Point: ☒ Destination ☐ Origin Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Final acceptance will occur following delivery, completion of required installation, and Government verification that the equipment, required accessories, and documentation conform to the requirements of Attachment 1, Requirements Document.

Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 30 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: Maria.Finan@fda.hhs.gov Phone: 240- 402-5712 Contract Specialist:

Name: Reagan Davis Email: Reagan.Davis@fda.hhs.gov Phone: 301-792-0910

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. 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.

e. 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.

f. 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.

g. 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.

h. 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 U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires the purchase, delivery, warranty, and acceptance of one (1) commercial Electrosurgical Unit (ESU) and all required accessories. The ESU will be used to generate electromagnetic disturbance signals that emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes. The acquisition includes all accessories necessary for full operation, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 30 calendar days after contract award. The equipment shall be new, unused, and fully operational upon completion of required installation and shall meet all technical and functional requirements specified in the Requirements Document.

PRE-AWARD ONLY (DELETE AT AWARD)

The sections below are required for the combined synopsis/solicitation when it is posted on SAM.gov under RFO 12.202. Delete this entire block at award; the content is pre-award only and does not survive award. The combined synopsis/solicitation statements required by RFO 12.202(b)(1)(i) remain in Section 1.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the responsible quoter submitting the lowest-priced quotation determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Quotations 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.

The Government will evaluate each quotation on a pass/fail basis to determine compliance with all salient characteristics and minimum requirements identified in the Requirements Document. The technical evaluation will include the offered equipment and required accessories, delivery requirements, and warranty requirements. A quotation that fails to meet any mandatory minimum requirement will be rated Technically Unacceptable and will not be eligible for award.

Failure to provide sufficient information or supporting documentation demonstrating compliance with each mandatory minimum requirement may result in the quotation being determined Technically Unacceptable.

Price: Among technically acceptable quotations, award will be made to the responsible quoter submitting the lowest evaluated price. Price will be evaluated for reasonableness.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of quotations from 30 calendar days to 90 calendar days from the date specified for receipt of quotations.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice Hard Date: August 30, 2026, 12pm ET Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Quotations 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 (if applicable): N/A

Offerors Shall Submit:

1. Technical quotation

1. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Manufacturer and country of origin for the ESU and each required accessory

The technical quotation shall provide sufficient information, including manufacturer, make/model number, product literature/specifications, and a cross-reference to each minimum technical requirement, to permit the Government to determine technical acceptability. The cross-reference shall identify the specific page or section of the quotation or manufacturer's product literature demonstrating compliance with each minimum technical requirement.

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.

Attachments (if applicable):

Requirements Document Electrosurgical Unit (ESU) and Required Accessories, CDRH-2026-134011.

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)