FDA’s Target Enterprise Architecture

Highlights from Axendia’s FDA e-Transformation Study – Part III

By Daniel R. Matlis

In this series of articles, we are sharing key insights and conclusions from our “FDA e-Transformation Initiatives” research study. 

In Part One of this series, we shared our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics. Part Two, highlights four key findings from this study.
To read the complete series visit: http://lsp.axendia.com/fda-e-transformation-study/

FDA’s Target Enterprise Architecture

In this, our third installment, we report on the FDA’s Target Enterprise Architecture

To meet its e-Transformation objective, the Agency is poised to deploy a new Target Enterprise Architecture (EA). FDA’s EA is part of the Health and Human Services (HHS) Enterprise infrastructure

This initiative provides a standard approach to strategize, architect, invest and implement a business-driven plan to achieve the desired end-state. 

The Target Enterprise Architecture (EA) provides FDA with a business-driven plan that describes the desired end-state for its business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.


The primary purpose of the Target EA is to effectively plan a course for achieving the FDA’s strategic vision and goals. It is one element in a broader set of interrelated activities that collectively enable the FDA managers and staff to define a vision, develop strategies and plans for achieving the vision, make resource decisions, implement strategies and evaluate performance.              

By defining the end-state from several distinctive perspectives (e.g. business, data, etc.), the Target EA will also provide stakeholders with a view into the complex relationships that exist among these different perspectives.  For example, the Target EA will provide insight into how a particular need translates into a set of target FDA business processes, and how those business processes will be supported by a common set of technologies.

Specific objectives of the FDA’s Enterprise Architecture are to:

Improve Program Performance
The overarching benefit of the Target EA is that it provides opportunities to improve the efficiency and effectiveness of the FDA’s programs. It ensures that data is optimized in support of the business, and applications and technology solutions are driven by business needs. It also allows FDA to more readily share services/data across organizational and functional lines.

Improve Interoperability
The Target EA establishes enterprise-wide standards that promote platform and vendor independence, enabling greater interoperability across disparate applications, both internal and external.

Improve Utilization of Resources
The Target EA reduces system development and operation and maintenance costs by eliminating duplicative investments, promoting sharing of common services, and establishing Agency-wide standards.

Accelerate System Implementation
The Target EA equips the Agency’s system developers and architects with an inventory of component-based services from which to choose that provide well defined functionality, thus maximizing reuse and portability of previously developed processes, components, code, etc.

Simplify Investment Decisions
The Target EA provides a view from strategy to business function to technology, allowing decision-makers to be able to more quickly assess the relative value of initiatives, and to identify duplicative and misaligned initiatives.

FDA’s Target Enterprise Architecture will provide a concrete framework on which to build solid applications. Figure 2 provides a detailed list of initiatives currently underway to modernize the agency’s infrastructure.





FDA Initiatives.jpg
The FDA has an ambitious plan to transform the way it interacts with its constituents.  Thorough planning and a solid foundation are critical to the success of this transformation.       

I think Dr. Donna-Bea Tillman, Director of the Office of Device Evaluation CDRH, said it well. “We don’t want to pave the cow-path. The real promise of Electronic Review lies beyond simply receiving submissions in electronic format”     


The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.




Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.       

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