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In this section: Public Health Preparedness and Response

Innovative Technologies

What's New

June 20, 2025: Manufacturing infrastructure increasingly includes numerous connected devices, considered Operational Technologies (OT), which have historically been designed to prioritize consistent functionality over cybersecurity. Consequently, it is sometimes difficult to tell what, when, and where network communications occur - potentially increasing the risk of a cybersecurity incident. Making state-of-the-art cybersecurity standards part of industry best practices for manufacturers of all sizes will help to considerably reduce the vulnerability of U.S. medical production and its supply chain. To bring attention to and summarize these practices, the FDA has released a white paper, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing (PDF 5.1MB).

Innovative technologies—such as advanced manufacturing—can improve medical product quality, increase manufacturing efficiency, address product shortages, and speed time-to-market. They may also enable entirely new approaches to creating medical products and unlocking unprecedented possibilities to protect and promote public health.

The Office of Regulatory and Emerging Science (ORES) conducts and supports regulatory science research and training to help advance the development and adoption of innovative and emerging technologies that may be used across multiple product areas—including new processes, standards, and technologies for manufacturing, testing, and inspection of FDA-regulated products. This “cross-cutting” approach augments the product-specific work pursued by FDA’s Center-based advanced manufacturing, emerging technology, and digital health programs. Our work strengthens FDA’s ability to respond to public health emergencies, increase manufacturing flexibility, and improve supply chain resilience to prevent and address product shortages, and ensure the safety, efficacy, and quality of FDA-regulated products.

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Innovative Technologies Regulatory Science Research

Learn more and view extramural and intramural projects.

Innovative Technologies and Advanced Manufacturing (I-TEAM) Hub

A collaboration space for advancing emerging technology innovation and training.

Image illustrating the concept of advanced manufacturing for medical products

Public-Private Partnerships

Learn more about public-private partnerships to proactively address challenges presented by emerging technologies.

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