Sources_Sought_CDRH-2026-134055.docx

SOURCES SOUGHT NOTICE

This is a Sources Sought Notice only. This is NOT a solicitation for proposals, proposals abstracts, or quotations.

1. GENERAL INFORMATION

Agency: U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) Notice Type: Sources Sought Solicitation Number: CDRH-2026-134055 Title: High-Power RF Amplifiers for Therapeutic Ultrasound Research NAICS Code: 334519 – Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing Response Due Date: June 2, 2026, 12:00 PM Eastern Time Point of Contact: As listed on SAM.gov

2. BACKGROUND AND PURPOSE

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is conducting market research to identify qualified small business sources capable of providing high-power RF amplifiers in support of regulatory science research on therapeutic ultrasound (histotripsy) devices. The amplifiers will be used to generate and characterize acoustic pressure and temperature fields produced by histotripsy devices.

3. REQUIREMENT DESCRIPTION

The FDA requires the following two (2) RF amplifiers:

1. E&I 2400L Power Amplifier – 10 kHz to 10 MHz, 400+ Watts, including cables and connectors

1. E&I A300 Power Amplifier – including cables and connectors At a minimum, the amplifiers shall meet the following specifications:

1. Frequency Range: 10 kHz (minimum) to ≥35 MHz (maximum)

1. Rated Power: Minimum 400 W (10 kHz to 10 MHz)

1. Rated Power: Minimum 300 W (10 MHz to 35 MHz)

1. Gain: 55 dB minimum

1. Input and Output Impedance: 50 Ohms nominal

1. AC Input: 100–264 VAC, 47–63 Hz

1. Class A

1. Temperature Range: 0–40°C

1. Cooling: Forced air

1. Compatible with most signal generators Additional deliverables include:

1. Technical documentation (calibration records, test reports, and/or technical datasheets)

1. Installation and training at the FDA White Oak Campus, Silver Spring, MD

1. Three (3) year manufacturer's warranty

1. Option for one (1) year extended warranty

4. REQUESTED INFORMATION

Interested small business firms are requested to submit a capability statement that includes the following information:

1. Company Information: Company name, address, point of contact, phone number, and email address.

1. Business Size and Socioeconomic Status: Identify your business size and any applicable socioeconomic categories (e.g., Small Business, 8(a), HUBZone, SDVOSB, WOSB) under NAICS Code 334220.

1. Capability to Provide Required Equipment: Describe your company's ability to provide the E&I 2400L and E&I A300 amplifiers, or equivalent products meeting the technical specifications listed above. Include whether your company is the manufacturer or a reseller/distributor.

1. Past Performance: Provide up to three (3) examples of similar equipment provided to government or commercial customers within the last three (3) years, including contract number (if applicable), customer name, and description of work.

1. Delivery Capability: Confirm your ability to deliver, install, and provide training within 90 days of contract award.

1. Warranty: Confirm whether you can provide a three (3) year manufacturer's warranty and an option for a one (1) year extended warranty.

1. SAM.gov Registration: Confirm active registration in SAM.gov and provide your Unique Entity Identifier (UEI).

5. DISCLAIMER

This Sources Sought Notice is issued solely for market research and planning purposes. It does not constitute a solicitation, a Request for Proposal (RFP), or a Request for Quotation (RFQ). Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government will not pay for any information submitted in response to this notice. Proprietary information should be clearly marked.

The Government is not obligated to issue a solicitation as a result of this notice. If a solicitation is issued, it will be posted on SAM.gov. It is the responsibility of interested parties to monitor SAM.gov for further information.

6. SUBMISSION INSTRUCTIONS

Responses shall be submitted electronically via email to the Point of Contact listed on SAM.gov no later than June 2, 2026, 12:00 PM Eastern Time. Responses shall be limited to ten (10) pages and submitted in PDF or Word format.

Questions regarding this Sources Sought Notice may be submitted to the Point of Contact listed on SAM.gov.