Merrill R A
Health Aff (Millwood). 1994 Summer;13(3):47-69. doi: 10.1377/hlthaff.13.3.47.
The U.S. Food and Drug Administration's (FDA's) drug approval process has evolved from a system in which a drug could lawfully be marketed unless the FDA were able to prove that the manufacturer knew that the drug would not work for the conditions for which it was promoted to one in which drug-makers require advance approval from the agency for almost every important step in testing, production, and marketing. The more modern system for regulating medical devices is the product of amendments to the federal Food, Drug, and Cosmetic Act in 1976. In those amendments, Congress sought to create a framework for control of device technology that would also facilitate innovation. This paper suggests that, notwithstanding this aspiration, both external pressures and internal practices are inexorably bringing device regulation closer to the "drug model."
美国食品药品监督管理局（FDA）的药品审批程序已从一种药品在未经FDA证明制造商知晓该药品对其推广适用病症无效时即可合法上市的体系，演变为制药商在测试、生产及营销的几乎每一个重要环节都需事先获得该机构批准的体系。更为现代的医疗设备监管体系是1976年对联邦《食品、药品和化妆品法案》进行修订的产物。在这些修订案中，国会力图创建一个既能控制设备技术又能促进创新的框架。本文表明，尽管有此愿景，但外部压力和内部做法都在无情地使设备监管更趋近于“药品模式”。
