FDA Regulatory Compliance & 510(k) Submission Services

The contract requires the development of a comprehensive regulatory strategy and full management of the FDA 510(k) clearance pathway for a Class II medical device, encompassing all phases from pre-submission interactions with the FDA to the final submission and documentation. This includes coordinating with the agency to align on technical and regulatory expectations, preparing and organizing all required submission components, and ensuring compliance with current FDA guidelines to maximize the likelihood of successful clearance. The work spans the entire pre-market regulatory lifecycle and demands deep expertise in medical device regulations and FDA processes. The contract is classified as a subcontract under the NAICS code 541611, issued by the Department of Defense through its office at Aberdeen Proving Ground. It was posted on June 30, 2026, with a firm deadline for response on July 17, 2026, at 8:00 PM Eastern Time. The procurement is not subject to any set-aside classifications, and performance is expected to be conducted at Aberdeen Proving Ground, though specific location details beyond the city are not provided. All deliverables must meet federal compliance standards, and the contractor must be prepared to engage directly with agency representatives to meet evolving regulatory requirements.