Medical Device Regulatory Compliance and Labeling Services

The contract seeks regulatory support services for FDA Class I medical devices, covering full compliance with 21 CFR Part 807 and Part 820 requirements. Services include preparing and maintaining documentation, ensuring accurate labeling, completing device registration and listing with the FDA, and establishing proper recordkeeping systems to meet federal quality and regulatory standards. The work supports the Department of Defense’s Medical Supply Chain FSH in maintaining lawful and efficient distribution of Class I medical devices within the U.S. healthcare and military supply systems. This is a subcontract opportunity posted on July 12, 2026, with a response deadline of July 20, 2026. It falls under NAICS code 541611, which pertains to administrative management and general management consulting services. The performance location and exact place of work are unspecified, and no set-aside status or point of contact details are provided. The solicitation is accessible via the DIBBS portal, and potential bidders must ensure adherence to all FDA regulatory frameworks while delivering tailored compliance solutions aligned with DoD procurement needs.