Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health

摘要

Within the U.S. Food and Drug Administration (FDA), the Center for Devices and Radiological Health (CDRH) is responsible for assuring the safety and effectiveness of a broad array of medical devices, ranging from implantable defibrillators to CT scanning devices and from artificial hips to software programs used in diagnosing disease. We are committed to fostering innovation in device development, assessment, and manufacturing, and to providing the public with accurate, science-based information about the products we oversee.As technology advances, medical devices are becoming increasingly complex. We must be able to anticipate these advances, creating the scientific tools that will assist the industry in developing new products and assessing their safety, effectiveness, quality, and performance. Regulatory science enables us to do this. Regulatory science activities include researching how new devices interact with the body, developing test methods for new technologies, testing products to identify root causes of failure, and developing epidemiological methods to help conduct postmarket studies of devices.