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*CDRH Center Tracking System (CTS) Modernization

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Food and Drug Administration is seeking to modernize the CDRH Center Tracking System (CTS), a mission-critical enterprise platform essential for Total Product Life Cycle regulatory review activities. The current system suffers from over twenty years of technical debt and thousands of embedded business rules, resulting in architectural fragility, scalability limitations, and performance constraints that hinder regulatory efficiency. This modernization effort aims to replace the aging infrastructure with a scalable, interoperable, and maintainable architecture to reduce operational risk. By updating the platform, the agency intends to align with its strategic priorities of innovation and global leadership, ensuring the system can adapt to evolving program demands and effectively support the full product life cycle regulatory mission.

General Info

FDA seeks to modernize the CDRH Center Tracking System for improved regulatory efficiency.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541512 - Computer Systems Design Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.