Medical Device Manufacturing – Foley Catheters

The contract pertains to the manufacturing of sterile, disposable 18 FR, 3-way urethral Foley catheters constructed from siliconized rubber, each equipped with a 5 mL balloon, under strict quality control protocols aligned with FDA 21 CFR Part 820 requirements. The production must adhere to rigorous medical device standards ensuring sterility, performance, and consistency, with all processes subject to comprehensive validation and documentation to meet regulatory compliance. The work is to be performed by a qualified subcontractor who can guarantee adherence to technical specifications and regulatory oversight throughout the manufacturing lifecycle. This subcontract is issued under NAICS code 325620 by the Department of Defense through the MEDICAL SUPPLY CHAIN MD SURG FSF, with the place of performance listed as FPO, ZIP 96672-4090. The solicitation was posted on July 16, 2026, with responses due by July 22, 2026, indicating a tight turnaround for proposals. The nature of the requirement suggests a critical support role in military medical logistics, requiring not only production capability but also the ability to meet exacting quality assurance timelines and documentation standards expected by federal healthcare and defense procurement entities. All delivered units must be traceable, properly labeled, and accompanied by necessary certification records to affirm compliance with FDA and DoD medical supply directives.