Medical Device Supply / Manufacturing (OEM or Alternate Source)

The contract seeks the manufacture or supply of a 5.5-inch plastic fracture detector designed to meet DLA NSN specifications and comply with FDA regulatory requirements, without requiring a 510(k) premarket notification. This is an OEM or alternate source subcontract under the NAICS code 339113, targeting suppliers capable of producing medical devices that align with military and regulatory standards for medical inventory systems. The solicitation is open for responses until July 22, 2026, with performance expected at the FPO location, zip 96662, under the Department of Defense’s Medical Supply Chain FSH agency. The device must be fully compliant with applicable FDA guidelines while exempt from the 510(k) process, indicating it is classified as a non-significant risk or exempt Class I device, and must be produced to exacting defense supply chain specifications for standardized use across military medical operations.