Solicitation_CDRH-2026-134633.pdf

ALP: CDRH-2026-134633

75F40126Q00391

Pulsed Field Ablation System 1

FSB Version 2.0 (June 8, 2026)

Request for Quotation (Supplies)

Section 1 General Information & Summary of Requirement

This is a Request for Quotation (RFQ) for commercial products prepared in accordance with the commercial acquisition procedures of RFO Part 12.

The Solicitation number is 75F40126Q00391.

The NAICS Code for this requirement is 334510 - Electromedical and Electrotherapeutic

Apparatus Manufacturing

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

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

☐ Other:

The small business size standard for this NAICS code is 1250 employees. The full table of size standards is available at: https://www.sba.gov/document/support-table-size-standards

Description of Requirement: The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has a requirement for one complete, off-the-shelf Pulsed Field

Ablation (PFA) system for use in a non-clinical research environment. The required system includes a PFA generator, five compatible clinical PFA catheters, all required accessories/cables/connectors, applicable software and licenses, setup/startup assistance, functional testing, training, warranty coverage, and technical support, in accordance with

Attachment 1 - Statement of Work (SOW).

Attachment 1: Statement of Work (SOW), CDRH-2026-134633, Procurement of a Pulsed Field

Ablation (PFA) System for Non-Clinical Research Use.

Section 2 Period of Performance / Delivery

Delivery. Delivery shall be completed within thirty (30) calendar days after receipt of order (ARO) to 10903 New Hampshire Avenue, Silver Spring, MD 20993. Delivery shall be FOB Destination. The Contractor is responsible for all packing, shipping, transportation, insurance, and delivery costs.

Setup/Startup and Functional Testing. The Contractor shall provide setup and startup assistance as required by the SOW. Following delivery and initial setup, the Contractor shall perform functional testing demonstrating that the system operates as intended and in accordance with the manufacturer's specifications. Government acceptance will occur after successful completion of the inspection and acceptance requirements in the SOW.

Training. Training shall be completed within fifteen (15) business days after delivery and prior to Government acceptance, unless otherwise agreed to in writing. Training may be conducted in person or virtually in accordance with the SOW.

Warranty. The PFA generator and all durable components shall include the manufacturer's standard commercial warranty for a period of not less than twelve (12) months beginning on the date of Government acceptance.

Period of Performance. The base period encompasses delivery, setup/startup assistance, functional testing, training, and the twelve-month warranty period. Following Government acceptance, the Contracting Officer may issue an administrative modification to memorialize the

Pulsed Field Ablation System 2 warranty dates, anchored to the Government acceptance date. Such administrative modification will not change scope, price, or any other substantive term.

Section 3 Contract Line Items (CLINs)

Item/CLIN Description Quantity Unit of Issue Unit Price

Extended Price

0001 Complete PFA System

- one new, current-production PFA generator and all durable accessories, cables, connectors, adapters, required software/licenses for the Government's non-clinical research use, setup/startup assistance, functional testing, training, 12-month minimum warranty, technical support, and FOB Destination delivery, in accordance with the

SOW.

1 EA $ $

0002 Compatible Clinical PFA Catheters - all five catheters shall be the same model/configuration.

Catheters shall be unused and unopened.

Expired catheters are acceptable solely for non-clinical research use when they meet SOW section 4.4.2.

5 EA $ $

TOTAL $ $

Section 4 Points of Contact

Contracting Officer:

Name: Iris Johnson

Email: Iris.Johnson1@fda.hhs.gov

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Phone: (301) 796-3353

Contracting Officer's Representative (COR):

COR will be designated at the time of award.

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Section 5 Contract Clauses

Clauses Incorporated by Reference

The following clauses apply:

Appl. Clause No. Clause Title Date

REQ 52.212-4 Terms and Conditions—Commercial Products and Commercial Services (use Alt I for T&M/LH)

Nov 2025

X 52.204-13 System for Award Management—Maintenance Nov 2025

X 52.204-91 Contractor Identification Nov 2025

X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

X 52.222-19 Child Labor—Cooperation with Authorities and Remedies Nov 2025

52.222-35 Equal Opportunity for Veterans Nov 2025

X 52.222-36 Equal Opportunity for Workers with Disabilities Nov 2025

X 52.222-50 Combating Trafficking in Persons Nov 2025

REQ 52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026

X 52.225-3 Buy American - Free Trade Agreements-Israeli Trade Act

Nov 2025

X 52.225-3 w/Alt II

Buy American - Free Trade Agreements-Israeli Trade Act

X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

May 2024

X 52.232-33 Payment by Electronic Funds Transfer—System for Award Management

Oct 2018

X 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Mar 2023

X 52.233-3 Protest After Award Nov 2025

X 52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

X 52.240-91 Security Prohibitions and Exclusions Nov 2025

X 52.244-6 Subcontracts for Commercial Products and Commercial Services

Nov 2025

X HHSAR

352.203-70

Anti-Lobbying Jun 2026

REQ HHSAR

352.232-71

Electronic Submission of Payment Requests Apr 2026

Clauses Incorporated by Full Text

Pulsed Field Ablation System 5

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 RFO 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 Products and Commercial Services included in commercial item contracts. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll 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 a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3–5 business days of contract award for new contracts or date of modification for existing contracts.

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.

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 the first, contains a temporary password. You must log in with the temporary password within 30 days.

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

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.

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d. Invoices that include time-and-materials or labor-hour 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 and contract cumulative amounts. At a minimum, the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

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;

Indirect Costs (i.e., Fringe Benefits, Overhead, G&A, Other Indirects) – show rate, base, and total amount;

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

Travel – include for each trip the name of the traveler, date, destination, transportation costs (including ground transportation separately), and per diem costs;

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

Other Direct Costs – include a listing of all other direct charges to the contract (e.g., office supplies, telephone, duplication, postage); and

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: (1) a list of all invoices submitted to date under the subject award, including invoice number, amount, and date submitted, as well as corresponding payment amount and date received; (2) total amount of all payments received to date under the subject contract or order; and (3) 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 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 the U.S. Food and Drug Administration such as acts of

God, inclement weather, power outages, 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

Pulsed Field Ablation System 7 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. When emailing, please include the contract number, invoice number and date, your name, phone number, and a detailed description of the issue.

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Section A Solicitation Provisions

Provisions Incorporated by Reference

The following provisions apply:

Appl. Provision No.

Provision Title Date

REQ* 52.212-2 Evaluation—Commercial Products and Commercial Services (*Required for RFO 12.201-2; optional for 12.201-1 simplified procedures)

Nov 2025

X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation

Jan 2017

X 52.204-7 System for Award Management—Registration Nov 2025

X 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products

Nov 2025

X

X

52.225-4 Buy American—Free Trade Agreements—Israeli Trade Act Certificate

Nov 2025

X 52.225-4 w/Alt II

Buy American—Free Trade Agreements—Israeli Trade Act Certificate

Nov 2025

X 52.225-18 Place of Manufacture Aug 2018

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation

Nov 2025

X 52.240-90 Security Prohibitions and Exclusions Representations and Certifications

Provisions Incorporated by Full Text

52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar

Pulsed Field Ablation System 9

(End of provision)

Section B Evaluation

Basis for Award

Lowest Price Technically Acceptable (LPTA). Award will be made to the responsible quoter whose quotation is determined technically acceptable and offers the lowest evaluated price.

Technical acceptability will be determined on a pass/fail basis against the minimum requirements of the solicitation and Statement of Work. A quotation that fails to meet any minimum requirement may be determined technically unacceptable and will not be considered for award.

Hemolysis-Related Safety Information – Pass/Fail. The Government will evaluate whether the quoter has provided the hemolysis-related history, safety-profile discussion, and supporting documentation required by SOW Section 4.7.2. A quotation that does not provide sufficient information to address this requirement may be determined technically unacceptable.

Price. Price will be evaluated for reasonableness. Among quotations determined technically acceptable, award will be made to the quoter with the lowest evaluated price.

Section C Instructions to Offerors

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (NOV

2025)

(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include—

(1) The solicitation number;

(2) The name, address, telephone number of the Offeror;

(3) The Offeror's Unique Entity Identifier (UEI) and, if applicable, Electronic Funds

Transfer (EFT) indicator;

(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;

(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award

Management (SAM)); and

(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of offers.

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(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is "late" and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal

Government processes resume.

(4) Offerors may withdraw their offers by written notice to the Government received at any time before award.

(d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror's initial offer should contain the Offeror's best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received.

(e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed

Offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award.

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.

(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities.

Pulsed Field Ablation System 11

Addendum to RFO 52.212-1

(b) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers.

(f) Question Deadline. Thursday August 27, 2026, 10:30 am ET. Submit all procurement-related questions in writing via email to the Contracting Officer identified in Section 4. Questions must be received by the deadline above to be considered.

(g) Quotation Deadline. Quotations are due by the date and time listed in the SAM.gov system and must be submitted via email.

(h) Quote Format and Submission Requirements.

The Contractor shall submit a firm-fixed-price quote that includes details supporting the price for all required deliverables. Quotes shall be for all deliverables requested. Discounts or other concessions are encouraged. Quotes shall be submitted in the following format: standard 8.5" x

11" page size, 1-inch margins on all sides, minimum 11-point font. Illegible or non-conforming submissions may be rejected without evaluation.

Submit two separate volumes:

Volume I – Technical: Must exclude all pricing information. The Technical Volume shall contain sufficient information for the Government to determine compliance with each minimum requirement of the Statement of Work (SOW). At a minimum, Volume I shall include:

• Technical Compliance Matrix: A paragraph-by-paragraph matrix addressing each applicable SOW requirement. The matrix shall identify the SOW section/paragraph number, indicate “Comply” or “Exception,” provide a brief explanation of how the proposed product meets the requirement, and identify the specific page or section of the supporting technical literature. Any exception or deviation shall be clearly identified and explained.

• Manufacturer, system name, model number, part/catalog number, and complete proposed configuration.

• Documentary evidence of the applicable FDA authorization, including the PMA approval number, 510(k) clearance number, De Novo classification number, or other applicable FDA authorization, and current product labeling/Instructions for Use.

• A complete component list identifying all equipment, catheters, accessories, cables, connectors, adapters, software, licenses, and other components included in the proposed configuration.

• Identification of all required software and licenses, including whether each license is perpetual, term-based, subscription-based, or otherwise restricted, and identification of any optional or primarily clinical-use software/components.

• Information demonstrating compatibility with the Government’s intended non-clinical research use.

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• The hemolysis-related history, safety-profile discussion, and supporting documentation required by SOW Section 4.7.2.

• Delivery timeline and description of the proposed setup/startup assistance and functional testing.

• Training approach and warranty/technical-support information.

• Country of origin/manufacture for each proposed end product.

Volume II – Price: Include completed pricing schedule and cost breakdown. The

Contractor shall include and complete the attached pricing schedule. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered acceptable.

(i) Quote Content Requirements. Quotes shall clearly reference the RFQ number and include:

• Date of quotation

• Company name

• Company Point of Contact name, email address, and phone number

• System for Award Management (SAM) Unique Entity Identifier (UEI)

• Quotation validity of at least 90 days after RFQ due date and time