*CDRH Center Tracking System (CTS) Modernization

The CDRH Center Tracking System (CTS) is a mission-critical, enterprise-wide platform that supports nearly all Total Product Life Cycle (TPLC) regulatory review activities across the Center; however, more than two decades of accumulated technical debt - including thousands of embedded business rules - have created significant performance constraints, scalability limitations, and architectural fragility that increasingly threaten CDRH's regulatory efficiency and capacity to respond to evolving program demands. The modernization will deliver a more performant, scalable, maintainable, and interoperable regulatory platform, reducing operational risk and enabling CDRH to more effectively support its regulatory mission across the full product life cycle. This investment directly advances CDRH's priority of Regulatory Efficiency & Modernization and aligns with the FDA Strategic Priority of Innovation and Global Leadership by replacing aging infrastructure with a modern, adaptable architecture capable of meeting current and future mission needs.

Estimated value

>= $3M and < $7M

Est. solicitation date

Jul 1, 2026

Anticipated award

Jan 1, 2027