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Medical devices: US medical device regulation

机译：医疗设备：美国医疗设备法规

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Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety, of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation. Published by Elsevier Inc.
机译：医疗设备受美国食品和药物管理局（FDA）器械和放射卫生中心的监管。器械和放射卫生中心负责通过确保医疗器械的安全性，有效性和质量，确保辐射发射产品的安全性，促进创新并向公众提供准确，科学的信息来保护和促进公众健康。在整个产品生命周期中基于我们所监管产品的信息。 1976年，美国食品药品管理局（FDA）被授权规范医疗器械的生产和销售。它并未规范医学实践。根据复杂性和风险级别对设备进行分类，“ 1976年之前”的设备无需经过FDA审查即可在分类后继续投放市场。可以通过510（k）上市前通知流程来清除1976年后具有较低复杂度和风险的设备，这些设备基本上等同于市售的“谓词”设备。 510（k）清除率通常不需要临床数据。相反，高风险设备通常需要获得上市前批准。上市前批准申请必须包含证明安全性和有效性得到合理保证的数据，并且该信息通常包括临床数据。对于风险不高的新型设备，从头流程允许FDA同时审查和分类新设备。根据美国《研究器械豁免》规定，在美国，未经合法许可销售的器械可用于临床研究。由Elsevier Inc.发布

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