Sources_Sought.docx

SOURCES SOUGHT NOTICE

Electrosurgical Unit

Room 1135 10903 New Hampshire Ave, Silver Spring, MD 20993-0002

1.0 PURPOSE AND DISCLAIMERTHIS 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 REQUIREMENTThe 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 60 calendar days after contract award. The equipment shall be new, unused, fully operational upon delivery, 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

3.0 INSTRUCTIONS TO RESPONDENTSResponses 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-2026-134011

- [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: CDRH-2026-134011 CompanyName.xlsx; and

(b) A capability statement not exceeding 5 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 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 Company Name / Address:

UEI / CAGE Code:

Point of Contact (Name, Phone, Email):

Active SAM.gov Registration (Yes/No):

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

Socioeconomic Categories (all that apply): 8(a); HUBZone; SDVOSB; VOSB; WOSB; EDWOSB; SDB; None

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

5.0 SMALL BUSINESS CAPABILITY QUESTIONS5.1. 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.

5.1A. Identify the manufacturer, product name, model number, and country of manufacture of the proposed ESU.

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.

5.3A. Warranty Capability Confirm that the proposed Electrosurgical Unit (ESU) includes, or can be provided with, a minimum one (1) year manufacturer's warranty covering parts, labor, and service, as required by the Performance Work Statement. If the standard commercial warranty differs, describe the available warranty coverage and any optional extended warranty offerings. State the estimated delivery lead time after award and whether delivery within 60 calendar days is achievable.

5.3B Delivery Capability State the estimated delivery lead time after award and confirm whether delivery within 60 calendar days is achievable

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

5.5 Technical Capability Questions

1. Identify the manufacturer and model proposed.

2. Provide a completed compliance matrix against each requirement.

3. Identify all deviations.

4. Confirm that all required accessories are included.

5. Confirm the output-frequency range.

6. Confirm the required operating modes.

7. Confirm the tissue-impedance monitoring capability.

8. Confirm warranty coverage.

9. State delivery lead time.

10. Provide product literature supporting the responses

6.0 DOMESTIC MANUFACTURE AND AVAILABILITY QUESTIONSAll 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 against the Section 2.0 quantities (sustainable output, available inventory, lead times). If you can satisfy the requirement only in part (insufficient quantity) or with deviations from the salient characteristics (insufficient quality), 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 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 the Trade Agreements Act.