Medical Device Regulatory Compliance & FDA Clearance Support

The contract seeks regulatory documentation to confirm FDA compliance for medical carts, specifically requiring verification of Class I exemption status or 510(k) clearance under 21 CFR Part 820. This subcontract is focused on ensuring that all medical carts meet federal regulatory standards for safety and efficacy, with the contractor responsible for providing accurate, authoritative proof of compliance to satisfy FDA requirements. The work is tied to the Department of Veterans Affairs through the 262-NETWORK Contract Office 22, with performance required in San Diego, CA, at the zip code 92161. The opportunity was posted on May 7, 2026, and responses must be submitted by May 15, 2026, at 5:00 PM Eastern Time. It falls under NAICS code 541611, indicating it relates to management, scientific, and technical consulting services, with an emphasis on regulatory affairs and medical device compliance. The contract does not specify a set-aside type and lacks detailed point of contact information, making it essential for potential bidders to review the full solicitation on SAM.gov to ensure all submission requirements are met.