Regulatory Affairs and FDA Submission Support

This contract involves providing regulatory affairs and FDA submission support specifically for the preparation and submission of documentation required for market clearance of a heart implant device. The scope includes handling FDA 510(k), PMA, or IDE submissions, ensuring all necessary regulatory requirements are met for the device's approval. The work is designated as a subcontract under the NAICS code 541611, which pertains to administrative management and general management consulting services. The contract is issued by the Department of Veterans Affairs through the 261-NETWORK Contract Office 21 (36C261), with the posting date listed as June 8, 2026. Details regarding the specific location of performance, point of contact, or any set-aside status are not provided. This engagement is focused on facilitating compliance and regulatory strategy to expedite the heart implant device’s successful clearance by the FDA.