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In this section: Public Health Preparedness and Response

Innovative Technologies

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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