Manufacture of FDA-Compliant Class I Urinal Bags

The contract pertains to the manufacturing of FDA Class I medical urinal bags that must strictly adhere to 21 CFR 876.5250, ensuring compliance with Good Manufacturing Practices, labeling regulations, and device registration mandates. The production must meet all federal standards for Class I medical devices, with emphasis on quality control, documentation, and traceability throughout the manufacturing lifecycle. The equipment and processes employed must be validated to maintain consistent product safety and performance, and final packaging must include accurate labeling as required by the FDA for medical devices in this category. The work is being procured as a subcontract under the Department of Defense’s Medical Supply Chain FSH, with performance required at Fort Bragg, North Carolina, in the 28310 ZIP code. The solicitation was posted on July 23, 2026, and responses are due by July 30, 2026. The NAICS code 325620 designates the industry as pharmaceutical and medicine manufacturing, confirming the technical scope aligns with medical device production. This subcontract is part of a broader effort to secure compliant, reliable medical supplies for military and healthcare operations, requiring bidders to demonstrate prior experience with FDA-regulated medical device manufacturing and the ability to meet strict logistical and regulatory timelines.