Endoscope System

The U.S. Food and Drug Administration's Center for Devices and Radiological Health requires procurement of a fully functional endoscope system to support medical device regulatory science research conducted by the Office of Science and Engineering Laboratories. The system must include a video processor with FDA 510(k) clearance, colonoscope with 170-degree field of view and 180-degree angulation capabilities, 4K medical display with minimum 32-inch diagonal, and mobile cart, all designed to operate on standard 120V, 60Hz electrical power. Key requirements include advanced imaging capabilities such as multiple LED light sources, narrow-band imaging modes, digital color enhancement, multiple video output formats including 12G-SDI and 3G-SDI, and the ability to save still images and video clips. The procurement follows Lowest Price Technically Acceptable evaluation criteria under FAR Part 13 Simplified Acquisition Procedures, where proposals will first be assessed for technical acceptability before price evaluation, with award going to the lowest-priced technically compliant offer. Electronic quotes must be submitted by September 18, 2025, at 12:00 PM EST, and vendors must provide proof of FDA clearance, technical specifications, delivery timeframe, warranty terms, and maintain active SAM registration.

This solicitation operates under full and open competition with no set-aside designations, utilizing NAICS code 339112 for Surgical and Medical Instrument Manufacturing with a small business size standard of 1,000 employees. No incumbent contractors or potential award values are specified in the documentation. The procurement calls for delivery of a single endoscope system within six weeks of contract award, accompanied by a mandatory one-year total system warranty covering parts, labor, and shipping costs. Performance will take place at the FDA's Silver Spring, Maryland location, where the system will be used by researchers for bench testing and evaluation of medical devices. The colonoscope component must feature specific technical parameters including a 3.7mm instrument channel diameter and precise angulation capabilities to meet the agency's regulatory science research objectives.