Brown J H
Biomed Eng. 1976 Oct;11(10):337-9.
The development of statutes to regulate the safety and efficacy of medical devices has been proceeding rapidly. The protection of the consumer from dangerous and ineffective devices is obviously necessary and must be carried out rapidly and efficiently. The electrical shock hazard in prevalence and violence is a case in point. There is no question that many devices are not well made and not suited for the function for which they are sold. These must be controlled, but at the same time we must be careful not to destroy the private research and development efforts which are producing reliable instrumentation through over control and regulation.
规范医疗设备安全性和有效性的法规制定工作一直在迅速推进。保护消费者免受危险和无效设备的伤害显然是必要的，而且必须迅速且高效地开展。普遍存在且危害严重的电击风险就是一个典型例子。毫无疑问，许多设备制作不佳，不适合其销售时所宣称的功能。这些设备必须加以管控，但与此同时，我们必须小心，不能因过度管控而破坏那些正在研发可靠仪器的私人研发工作。
