Regulatory & Compliance Support (FDA, Buy America, COTS)

The contract seeks consulting services to ensure full compliance with FDA regulations, the Buy American Act, and COTS determination requirements for federal medical device procurement. The vendor will provide expert guidance to navigate regulatory frameworks, validate domestic sourcing adherence under the Buy American Act, and confirm that commercial off-the-shelf products meet federal procurement standards for medical devices. Services are to be performed at Loma Linda, California, with a response deadline of July 28, 2026, and the opportunity is structured as a subcontract under the Department of Veterans Affairs, specifically managed by the 262-NETWORK Contract Office 22. The North American Industry Classification System code 541611 indicates the work falls under management consulting services, emphasizing strategic advisory support in regulatory compliance rather than product supply or direct manufacturing.