Regulatory Compliance and FDA Coordination

The contract pertains to regulatory compliance and FDA coordination for medical devices, requiring full adherence to U.S. Food and Drug Administration standards covering documentation, labeling, and submission support to ensure products meet all federal requirements for market entry and ongoing compliance. The scope involves managing the end-to-end regulatory process to facilitate approvals, maintain accurate records, and coordinate with FDA representatives as needed, with a focus on accuracy, timeliness, and alignment with current regulatory guidance. This subcontract is issued under the NAICS code 541611 for management consulting services, sponsored by the Department of Defense through the Medical Supply Chain MD Surg FSF, with performance to be conducted at APO, zip code 96260-5479. The solicitation was posted on August 4, 2026, and responses are due by August 10, 2026, with no set-aside designation applied. Contractors must be prepared to operate within stringent federal medical device regulatory frameworks and provide demonstrable expertise in navigating FDA submission pathways, including pre-market notifications, design controls, and quality system compliance.