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  1. CDRH Reports

Regulatory Science Report

Thumbnail of the report's cover page, showing closeups of 3 instances of medical device innovation - laser testing in a lab, a mobile medical app, and 3D medical imaging.

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FDA's Center for Devices and Radiological Health (CDRH) has released a report highlighting its progress in regulatory science. The report, "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health," describes a broad array of scientific efforts at CDRH that are designed to foster innovation in the development of medical devices while at the same time providing the Center with sound, accurate information to evaluate their safety, quality and performance. Aimed at patient groups, researchers, industry, health care professionals, and other stakeholders, the report gives readers an idea of the scope of scientific activities at CDRH and how they support device innovation and protect public health. The regulatory science projects cited in the report range from providing device designers with computer modeling that can enable them to predict the performance of cardiovascular devices to developing standard tests for the durability and performance of spinal disc implants.

CDRH Regulatory Science Priorities


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