Regulatory Compliance & FDA Submission Support

The contract requires comprehensive regulatory consulting and documentation support to ensure compliance with FDA 880.5860, focusing on the preparation and submission of 510(k) applications, development of accurate and compliant labeling, facility registration, and readiness for Good Manufacturing Practice audits. The scope encompasses end-to-end regulatory strategy and execution to meet FDA expectations for medical devices, with an emphasis on timely and accurate submission of all required documentation to facilitate approval and market access. The contractor must demonstrate expertise in FDA regulatory processes and possess the ability to navigate complex compliance requirements within a defense medical supply context. Performance of this subcontract is designated for Groton, Connecticut, with a response deadline of August 3, 2026, and is categorized under NAICS code 541611 for management, scientific, and technical consulting services. The work is under the Department of Defense, specifically the Medical Supply Chain MD Surgical FSF, indicating a critical support role for military medical device regulatory compliance. There is no set-aside designation specified, and the subcontractor is expected to deliver full-service regulatory support without reliance on external documentation or references, ensuring all activities are executed in alignment with FDA standards and defense requirements.