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*GUDID Migration to the FURLS Platform - Agency IT 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 technical expertise to migrate the Global Unique Device Identification Database into the FDA Unified Registration and Listing System as an integrated module. This initiative aims to consolidate establishment registration, device listing, and unique device identification into a single platform to eliminate redundancy and resolve data quality issues caused by the current standalone nature of the GUDID application. By integrating these domains, the agency intends to strengthen data integrity through cross-system validation and enhance regulatory efficiency and analytical capabilities for the Center for Devices and Radiological Health. The selected contractor will be responsible for the design, development, testing, and deployment of the integration within the current fiscal year. This project is a key component of the agency's IT consolidation strategy and modernization priorities, focusing on maintaining continuity of operations and minimizing disruptions for the regulated industry. The effort is designed to provide a more holistic oversight of the medical device ecosystem while advancing the FDA's goals regarding innovation and global leadership.

General Info

FDA seeks technical expertise to migrate GUDID into the Unified Registration and Listing System.

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

This proposal to support the migration of the Global Unique Device Identification Database (GUDID) into the FDA Unified Registration and Listing System (FURLS) as an integrated module, consolidating the three complementary domains of medical device regulation - establishment registration, device listing, and unique device identification - into a single, cohesive platform. GUDID currently operates as a standalone application with limited cross-system integrations and validations, contributing to data quality challenges and an artificial regulatory separation that impedes holistic oversight of the medical device ecosystem. Migrating GUDID into FURLS will eliminate platform redundancy, strengthen data integrity through cross-system validation, and deliver measurable gains in regulatory efficiency and analytical capability in support of the CDRH's review tools and performance analytics functions. This effort directly advances FDA's agency IT consolidation strategy and aligns with CDRH priorities in Regulatory Efficiency & Modernization, as well as FDA's broader commitment to Innovation and Global Leadership. Contractor services will provide the technical expertise necessary to design, develop, test, and deploy the GUDID-FURLS integration within the fiscal year, ensuring continuity of operations and minimal disruption to regulated industry.