Endoscopy System

The Food and Drug Administration is forecasting a procurement for an endoscopy system to enhance scientific research capacity within OSEL and the broader agency, aimed at advancing the evaluation of endoscopic devices. This acquisition is critical for developing standardized bench testing methods to assess the safety and effectiveness of endoscopy technologies, particularly in support of AI/ML initiatives led by Feng Yang and Wei-Chung Cheng. The system will enable the creation of color performance testing protocols and independent AI/ML validation frameworks, filling a key gap in the agency’s ability to define practical, evidence-based testing requirements for industry sponsors. Without this equipment, OSEL lacks the necessary tools to evaluate how variations in endoscope design and image properties influence AI/ML performance, severely limiting its capacity to provide actionable guidance for regulatory submissions. The procurement is classified under NAICS code 111333 and is being managed by the FDA’s Center for Devices and Radiological Health, with the point of contact for acquisition inquiries listed as cdrhacquisitions@fda.hhs.gov. The contracting officer role remains undesignated, and no specific set-aside or solicitation number has been assigned at this forecast stage. The endoscope will be deployed to support internal research and development activities aimed at improving regulatory science outputs in real-time imaging and AI-driven diagnostics. Failure to acquire this system would fundamentally hinder the agency’s ability to keep pace with technological advancements in endoscopic devices and the AI systems that increasingly rely on their output, potentially delaying the approval of innovative medical technologies and compromising patient safety evaluations.