Runner Susan
Center for Devices and Radiological Health, Office of Device Evaluation, Food and Drug Administration, Rockville, MD, USA.
J Evid Based Dent Pract. 2006 Mar;6(1):19-23. doi: 10.1016/j.jebdp.2005.12.017.
The Food and Drug Administration (FDA) is the federal agency that is tasked with regulating market entry for medical devices. The laws that govern this process are codified in the Federal Food Drug and Cosmetic Act (the Act) and the regulations are based on this law. The medical device amendments to the Act were instituted in 1976, instituting the methods for classification of medical devices and the format for the premarket review of devices. Information for practitioners on how medical devices come to market, what data are required, how specific claims are cleared, and how the practitioner can give input to the system are critical for the further development of safe and effective medical devices.
美国食品药品监督管理局（FDA）是负责监管医疗器械市场准入的联邦机构。管理这一过程的法律编纂于《联邦食品、药品和化妆品法案》（该法案）之中，相关法规也基于此法律制定。该法案的医疗器械修正案于1976年制定，确立了医疗器械分类方法以及器械上市前审查的形式。对于从业者而言，了解医疗器械如何进入市场、需要哪些数据、特定声明如何获批，以及从业者如何向该体系提供意见，对于安全有效的医疗器械的进一步发展至关重要。
