FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

Page | 1

We need the ability to create 

systems that allow us to 

keep up with the 

complexities of the 

industries and products we 

regulate with immense 

consequences for the health 

of all Americans.

Robert M. Califf M.D., MACC, 

Commissioner of Food and Drugs for the 

Food and Drug Administration

Message from the CIO

I am pleased to share the FDA IT Strategy for FY 2024 – FY 2027. 

This enterprise plan, shaped by FDA’s Centers and Offices and

external stakeholders, will guide FDA’s Information Technology (IT) 

direction and investments for the next four years. Over 250 

stakeholders provided input into developing the FDA IT Strategy 

through discovery sessions with IT and business leaders across the 

FDA, internal surveys, and a Federal Register request for 

information. FDA IT’s inclusive approach resulted in a set of goals 

and objectives designed to drive public health outcomes while 

meeting the needs of FDA’s diverse stakeholders. We plan to revisit 

this strategy annually to adapt and align with internal and external 

changes.

We are not beginning from a blank canvas – FDA IT’s modernization 

framework provides a strong foundation for what is to come. This framework takes a shared enterprise 

approach to drive business outcomes by focusing on action plans for technology, data, enterprise, 

cybersecurity, and leadership. I am incredibly proud of the significant advancements in FDA’s technology 

maturity during unprecedented challenges and change.

Technology’s role in promoting and protecting the health of the American people is only becoming more 

significant each year. The Centers and Offices within FDA, regulated industry partners, external 

collaborators, and others depend on the data and technology we provide to drive innovation, insights, and 

efficiency as they work to assure the safety, efficacy, and security of foods, drugs, and medical devices. 

As we reimagine the possible, FDA IT will transform how we align FDA’s technology with its business 

capabilities and needs while bolstering governance, modernizing critical systems, scaling IT solutions 

across the FDA enterprise, enabling data sharing, and 

leveraging emerging technologies. 

The macro-environment we operate in is complex. We 

are responding to rapid advancements and changes in 

demand from FDA’s regulated industries, competing for 

scarce IT talent, understanding use cases for emerging 

technologies (such as artificial intelligence (AI)), enabling 

business process modernization, optimizing investment

management, and continuing to break down barriers to 

data sharing and collaboration, all while protecting the 

assets, intellectual property, and personal information 

the public entrusts us with. We must enforce more 

robust governance, become more agile and think 

differently to narrow the gap between current IT 

capabilities and the rapid pace of innovation and 

technology advancements to continue protecting the 

American people. 

With this strategic plan, we will build on the foundation established through FDA IT’s modernization 

framework to lead the FDA through the next phase of the Agency’s evolution. FDA IT’s Operating Plan 

will define an IT roadmap with a combination of projects already in progress and new projects. We will 

execute FDA’s IT roadmap in phases to make measured progress against the IT goals and objectives we 

define within this strategy.

Vid Desai 

Chief Information Officer 

Office of Digital Transformation
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

Page | 2

Executive Summary

Advancing Public Health Outcomes Enabled by Technology, Powered by Data

V I S I O N

Unleash FDA’s technology and data potential to improve health for all.

<M I S S I O N

Empower stakeholders to safeguard public health through high quality, secure technology, 

and data capabilities.

Food & Drug Administration (FDA) 

Information Technology (IT) Strategy
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

Page | 3

FDA IT Strategic Goals and Objectives

▪ Enhance Data 

Governance

▪ Foster 

OneFDA Data 

Literacy

▪ Improve Data 

Visibility and 

Accessibility

▪ Enable 

Advanced 

Data Analytics

▪ Enhance 

Secure Data 

Exchange

▪ Enhance 

Communication

and 

Collaboration 

▪ Promote 

Transparency 

▪ Optimize 

Investments

▪ Strengthen 

Governance

▪ Provide 

Flexible 

Infrastructure 

Offerings

▪ Accelerate 

Cloud 

Adoption 

▪ Ensure 

Service 

Availability 

▪ Implement 

Zero Trust 

Approach

1.Create a 

Shared 

OneFDA 

Ecosystem

2. Strengthen 

IT 

Infrastructure

▪ Increase 

Business 

Alignment 

▪ Scale 

Operations

▪ Increase 

Digital 

Maturity

▪ Improve 

Customer 

Experience

▪ Modernize 

FDA 

Cybersecurity 

Defenses

▪ Reduce 

Technology 

Debt

3. Modernize 

Enterprise 

Services and 

Capabilities

4. Share Data 

for Mission 

Outcomes 

▪ Balance 

Policy and 

Technology 

Value

▪ Ensure 

Responsible 

Use of 

Innovations

▪ Provide 

Thought 

Leadership

▪ Foster 

Innovation

5. Adopt AI 

and

MissionDriven 

Innovations 

▪ Instill 

OneFDA 

Mindset

▪ Attract and 

Retain 

Talent

▪ Hire and 

Develop 

Resilient 

Leaders

▪ Develop 

Skills for the 

Future of 

Work

6. Cultivate 

Talent 

and 

Leadership 
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

Page | 4

Strategic Direction

U.S. Department of Health and Human Services (HHS) agencies are enhancing the health and 

well-being of all Americans amidst an evolving public health landscape. The U.S. Food and 

Drug Administration (FDA), specifically, is focused on protecting public health by ensuring the 

safety, efficacy, and security of human and veterinary drugs, biological products, and medical 

devices. The FDA also safeguards the nation's food supply, cosmetics, and products that emit 

radiation.

A Case for Change

Across all these areas, science is evolving fast, technology and data environments are 

transforming rapidly, and regulations are changing to keep pace. FDA’s aging infrastructure, 

systems, and equipment need help to keep up. Outdated data exchange practices, unstructured 

data submissions, and undue limitations on data sharing are just a few of the roadblocks to 

unlocking the value of data-driven insights. We must accelerate FDA’s digital transformation 

journey to better support FDA’s business, technology, and regulatory needs today while 

proactively enhancing and developing new IT capabilities to drive FDA’s public health mission 

forward.

IT Vision and Mission

In alignment with HHS’s IT strategy and FDA’s mission, this IT strategy will leverage technology 

-– powered by data – to drive public health outcomes as described in FDA IT’s vision and 

mission. 

FDA IT Vision

Unleash FDA’s technology and data potential to improve health for all.

FDA IT Mission

Empower stakeholders to safeguard public health through high quality, secure technology, 

and data capabilities.

To accomplish all of this, we will pursue six strategic goals.
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

Page | 5

Strategic Goals

1 — Create a Shared OneFDA Ecosystem

Description: 

Establish greater access to trusted data and shared resources 

across Centers, Offices, and external stakeholders. Encourage 

and facilitate cross-functional investment in technology to 

support enterprise business objectives for speed, scale, and 

value through robust Agency level governance processes, 

enhanced collaboration channels, and technology products and 

services. Shift FDA’s culture to make sharing across Centers

and Offices and with external stakeholders (where relevant) the 

norm - where prioritizing Agency-level public health outcomes 

improves results for everyone.

Objectives:

1. Enhance Communication and Collaboration: Foster information and resource sharing with 

internal and external stakeholders to achieve both agency and specific stakeholder outcomes, 

using a variety of communication channels to reach broader audiences. Enable collaboration 

and develop strong partnerships across Centers and Offices through integrated technologies 

and platforms. 

2. Promote Transparency: Actively involve impacted stakeholders in IT solution planning, 

development, and execution to drive expected outcomes. 

3. Optimize Investments: Align the diverse needs across FDA to the overarching strategy 

through stronger financial fidelity, enhanced budget coordination, and improved financial 

planning. Ensure effective IT resource utilization, transparency in IT budget allocation, and 

measurement of results achieved.

4. Strengthen Governance: Ensure the effective and efficient use of IT in enabling the FDA to 

achieve mission outcomes through established standards, responsible procurement, and 

more robust decision-making and accountability mechanisms.
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

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2 — Strengthen IT Infrastructure

Description: 

Continue to modernize and secure the foundational IT 

infrastructure for all IT services and solutions. Proactively 

provide the ability to adapt to changes in workload demand, 

detect issues before they impact stakeholders, and quickly 

resolve technology issues to avoid disruptions to day-to-day 

operations.

Objectives: 

1. Provide Flexible Infrastructure Offerings: Provide a marketplace with usage-based models

for users to identify and implement the infrastructure solutions based on their business 

requirements with an appropriate chargeback model.

2. Accelerate Cloud Adoption: Empower users with cloud offerings to meet their mission 

needs, e.g., scalability and agility. Provide best practice guidance on cloud models, e.g., 

hybrid and transition strategies based on the unique needs across Centers and Offices. 

3. Ensure Service Availability: Provide stable access to IT services through proactive,

continuous monitoring of IT infrastructure service performance (e.g., Service Level 

Agreements, Operating Level Agreements) and feedback from FDA users to identify potential 

problems and implement targeted improvements. 

4. Implement Zero Trust Approach: Establish a comprehensive zero trust and risk-based

approach to obtain optimal maturity level by upgrading, modernizing, and enhancing FDA’s

security and cyber defenses. 

3 — Modernize Enterprise Services and Capabilities

Description: 

Optimize the IT services portfolio to support everyday needs 

with cross-cutting, mission-critical offerings and benefit from 

economies of scale. Ensure enterprise IT services are stable, 

resilient, and adaptive, with opportunities for stakeholders to 

tailor solutions, where appropriate, and feedback loops to drive 

continuous improvement. 

Objectives:

1. Increase Business Alignment: Lead with a business-first approach to modernizing

enterprise services and capabilities to ensure technology enables the capabilities defined in 

FDA’s Business Capability Model and supporting business processes.

2. Scale Operations: Develop and drive adoption of enterprise solutions for standard 

capabilities, e.g., Finance/Budget, Human Resources, Acquisitions, Inspections, Freedom of 
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

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Information Act requests, and Complaints Management with continuous user testing while 

providing flexibility for customization where relevant. Manage the lifecycle of applications 

within the enterprise portfolio.

3. Increase Digital Maturity: Maximize the use of technology (e.g., data, automation) in core 

business areas and enable processes to improve their ability to adapt to changes and scale.

4. Improve Customer Experience: Create customer-centric solutions that enhance satisfaction 

by improving accessibility to IT solutions, including external-facing systems (e.g., Electronic 

Submission Gateway Next Generation), streamlining processes, and easing adoption.

Increase stakeholder engagement with FDA IT services by prioritizing customer and 

employee feedback and establishing formal feedback loops.

5. Modernize FDA Cybersecurity Defenses: Upgrade, enhance, and modernize FDA’s critical 

cyber defenses and practices to address the evolving threat landscape where risks to FDA’s

critical assets, industry, and sensitive data exist. 

6. Reduce Technology Debt: Decommission legacy systems, applications, and End-of-Life 

(EoL) devices and reinvest in enterprise solutions and business process improvements to 

minimize technical debt and enterprise risk.

4 — Share Data for Mission Outcomes

Description: 

Identify common data assets critical to stakeholders across FDA 

and make them widely available and consumable to drive 

operational efficiencies and excellence. Leverage valuable data 

assets and insights to develop new capabilities and services and 

enable public health innovation.

Objectives:

1. Enhance Data Governance: Implement AI-powered best practices for governance and 

enterprise data management that improve data quality, security, and the speed and 

accuracy of insights and decisions.

2. Foster OneFDA Data Literacy: Educate the workforce on best practices and the benefits of 

consuming, analyzing, and making data-based decisions.

3. Improve Data Visibility and Accessibility: Prioritize which data assets to make widely

available first based on value to the mission and the most significant number of 

stakeholders.

4. Enable Advanced Data Analytics: Ensure experts can easily combine and analyze 

information from various internal and external sources to gain comprehensive insights.

5. Enhance Secure Data Exchange: Improve interoperable and secure data exchange and 

collaboration across FDA and its public health partners.
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

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5 — Adopt AI and Mission-Driven Innovations

Description: 

Drive exploration and address impacts of emerging technologies 

and trends such as AI and virtual reality on the FDA’s IT portfolio 

and regulatory operations. Proactively identify opportunities and 

risks to FDA’s mission and inform responsible use of 

technology. Enhance partnerships with external experts to 

leverage these technologies and promptly respond to their 

impact.

Objectives:

1. Balance Policy and Technology Value: Develop ethical guidance for technology use while 

maximizing business value, such as guidance on AI strategy. Ensure responsible actions by 

conducting comprehensive research and analysis to fully understand technological 

advancements’ potential impacts and implications on society. 

2. Ensure Responsible Use of Innovations: Deploy technological innovations, such as 

AI/Machine Learning (ML), responsibly with an understanding of regulatory impacts and 

effective risk response strategies. Establish appropriate guardrails where necessary.

3. Provide Proactive Thought Leadership: Lead as a partner in creating novel use cases for 

emerging technologies through a deep understanding of business processes, industry, and 

technology. Stay at the forefront of technological advancements by harnessing industry 

expertise and fostering collaboration.

4. Foster Innovation: Create an environment where innovative approaches are encouraged, 

identified, shared, and evaluated for use in driving operational efficiency and developing new 

capabilities. Apply a structured process to manage the innovation lifecycle from ideation to 

investment to adoption (or project shutdown) to produce usable innovations.
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

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6 — Cultivate Talent and Leadership 

Description: 

Mature Agency-wide IT competencies to deepen technology 

expertise and keep pace with the accelerated rate of change in 

FDA’s regulated industries and technology. Develop holistic 

leaders equipped to lead through change and drive FDA’s digital 

transformation journey forward. Deliver enterprise IT services

with an Agency-first mindset. Given the continued competition 

for talent, proactively build a robust talent pipeline for targeted 

roles leveraging a combination of recruitment, retention, and 

talent development strategies.

Objectives:

1. Instill OneFDA Mindset: Cultivate an Agency-first approach to IT so that decisions promote 

and protect the health of the American people first and foremost.

2. Attract and Retain Talent: Build a diverse talent pipeline through a compelling employee 

value proposition and total compensation approach, talent acquisition, employee 

engagement, and talent development strategies. Drive improvements across the employee 

lifecycle from recruitment to retirement.

3. Hire and Develop Resilient Leaders: Strengthen leadership competencies required to drive 

holistic transformational IT initiatives in a dynamic environment successfully. 

4. Develop Skills for the Future of Work: Develop IT skills and competencies required to 

deliver current and future IT services through upskilling, reskilling, and continuous learning.
FDA Information Technology Strategy 

for Fiscal Years 2024 to 2027

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Looking Ahead

FDA IT’s strategy reflects a bold, ambitious set of goals that focuses on strengthening the FDA’s

foundation while preparing for the future. Culturally, this strategy is a paradigm shift from an 

ODT-only IT strategy to an enterprise IT strategy designed and driven in collaboration with 

FDA’s Center and Office partners. Together, FDA’s empowered IT leaders and teams from 

across FDA will advance the continued transformation of the FDA’s IT capabilities, operations,

and organization – continuing to build upon the foundation established through FDA IT’s 

modernization framework. 

As we progress, FDA IT’s strategy will underpin governance decisions on budget formulation, 

investments, and resource allocation to focus on the highest priority areas for FDA’s public 

health mission. FDA’s Technology Council with agency-wide decision makers, and recently 

formed Technology Business Management Center of Excellence, will play critical roles in 

aligning FDA’s investments to this strategy and reporting on FDA’s progress. 

FDA IT’s Operating Plan, a companion to this strategy, defines tactical guidance for governance 

and execution. It includes a roadmap of the in-progress and upcoming initiatives and metrics for 

each IT strategic goal. We will revisit this plan annually and refine it to maintain relevance.

Thank you to the 250+ stakeholders across HHS, FDA, industry, vendors, and the public who 

contributed to developing the FDA’s first-ever Agency-wide IT Strategy. 

Vid Desai 

Chief Information Officer 

Office of Digital Transformation