Kennedy R S
Med Instrum. 1980 May-Jun;14(3):153-6.
The FDA's Bureau of Medical Devices has been charged with implementing the 1976 Medical Device Amendments. The bureau's activities have been concentrated in three areas--general controls, medical device standards, and device evaluation. In the area of general controls, the bureau has implemented regulations concerning good manufacturing practices, registration, product listings, banned devices, and administrative detention. Several other activities are planned for the near future, including the development of a mandatory experience reporting regulation, a restricted device regulation, and device repair, replacement, or refund provisions. FDA intends to rely on voluntary standards for medical devices, but will develop and promulgate regulatory standards as needed to protect the consumer. The device classification procedures have resulted in classification recommendations for approximately 1900 generic categories of products to date.
美国食品药品监督管理局（FDA）的医疗器械局负责实施1976年的《医疗器械修正案》。该局的活动主要集中在三个领域——一般控制、医疗器械标准和器械评估。在一般控制领域，该局实施了有关良好生产规范、注册、产品清单、禁用器械和行政扣押的法规。近期还计划开展其他几项活动，包括制定强制性经验报告法规、受限器械法规以及器械维修、更换或退款规定。FDA打算依靠医疗器械的自愿性标准，但会根据需要制定和颁布监管标准以保护消费者。截至目前，器械分类程序已对约1900个通用类别的产品给出了分类建议。
