Electrosurgical Unit

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is seeking a commercial Electrosurgical Unit designed to generate electromagnetic disturbance signals for laboratory testing, test method development, and verification activities. The unit must feature a touchscreen user interface, real-time tissue impedance monitoring, and operate within a frequency range of 400 kHz to 500 kHz, supporting monopolar, bipolar, and vessel-sealing modes. The system must be brand new, unused, and fully operational upon delivery, accompanied by all necessary accessories, comprehensive user and technical documentation, and a minimum one-year manufacturer’s warranty. Delivery is required within 60 calendar days of contract award, and the equipment must fully comply with all technical and functional specifications outlined in the Requirements Document. The acquisition is limited to one complete system, including everything needed for immediate and full operational use. The solicitation, identified as SSN-CDRH-2026-134011, was posted on July 15, 2026, with responses due by July 23, 2026. It falls under NAICS code 339112 and is managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. The office is located in Rockville, Maryland, with performance expected in Silver Spring, Maryland.Primary point of contact for inquiries is Reagan Davis, reachable via email at reagan.davis@fda.hhs.gov or by phone at 301-796-0910. No set-aside provisions apply, and the opportunity is open to all eligible vendors. The contract is currently in the sources-sought phase, seeking industry input to inform future procurement decisions.