Medical Device Regulatory Compliance and Labeling

The contract involves providing comprehensive FDA regulatory support for military medical kits, focusing on key areas such as registration, labeling, Good Manufacturing Practice (GMP) compliance, and Material Safety Data Sheet (MSDS) preparation. This subcontract under the Department of Defense aims to ensure that the medical devices meet all necessary regulatory requirements to maintain safety and compliance for military use. The work is to be performed in Annville, with a solicitation posted at the end of May 2026 and responses due in early June 2026. The contract falls under the NAICS code 541618, which relates to management consulting services, indicating that the support will likely involve expert guidance and oversight in regulatory matters. The opportunity is listed by the Medical Supply Chain MD Surg FSF office of the Department of Defense but does not specify a set-aside or particular organization type for bidding. The focus on FDA compliance highlights the critical nature of adhering to federal regulatory standards for medical devices used in military contexts. This contract ensures that all necessary documentation and labeling standards are met to facilitate safe deployment and use of medical kits, supporting the military’s operational readiness and health safety standards.