Mission Accomplishment and Regulatory Compliance Services

The Mission Accomplishment and Regulatory Compliance Services (MARCS) project supports the Food and Drug Administration (FDA) Office of Regulatory Affairs’ (ORA) critical work to safeguard the foods, drugs, devices, biologics, and veterinary products that the Agency regulates. MARCS supports the import program staff in the field performing import entry review including Prior Notice review, fieldwork assignment, and compliance decision-making for the millions of import entry lines that are received each year. MARCS systems also support the domestic business processes for planning and conducting inspections, federal/state partnerships, workload management, investigative operations, laboratory analysis, compliance work, and other critical initiatives. MARCS currently operates and maintains over 20 systems, including legacy applications and new services and components introduced to modernize and enhance the IT capabilities needed by ORA. Some of these functions are mission-critical and must be operational 24 by 7.