Supply of FDA-Regulated Medical Item (NSN: 6515013343233)

The contract pertains to the supply and delivery of a specific FDA-regulated medical item identified by NSN 6515013343233, requiring full compliance with all applicable FDA regulations including labeling requirements, device registration and listing, and adherence to current Good Manufacturing Practices. The item may necessitate a 510(k) premarket submission to establish substantial equivalence, and the supplier must ensure all manufacturing, testing, and documentation processes meet federal standards for medical devices. Delivery is directed to a military address in APO with ZIP code 09461-9997, under the oversight of the Department of Defense’s Medical Supply Chain MD Surg FSF organization. The solicitation was posted on July 13, 2026, with a response deadline of July 16, 2026, indicating a limited window for submissions. This is structured as a subcontract under NAICS code 325412, which classifies the manufacturing of pharmaceutical and medicinal chemicals. The item is intended for use within the U.S. military healthcare system, requiring strict adherence to defense supply chain protocols and FDA compliance. All proposals must demonstrate capability to meet regulatory, logistical, and quality assurance requirements without deviation, and failure to comply with labeling, cGMPs, or premarket obligations could result in disqualification or rejection of the bid.