Callahan T J, Marlowe D E
Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850.
J Long Term Eff Med Implants. 1993;3(4):269-76.
The regulatory management by the FDA of medical products should be thought of as a form of risk assessment and risk management. This is a new approach, a new way of thinking about product review and postmarket management processes. This paper outlines several aspects of risk assessment and management that have recently been incorporated into the FDA processes that will simplify reviews and lower the risks involved with the use of medical devices. These aspects include development of a new process for selecting the appropriate resources to dedicate to individual device applications, an increased emphasis on good experimental design for clinical studies, and continued development of a biomaterials database.
美国食品药品监督管理局（FDA）对医疗产品的监管管理应被视为一种风险评估和风险管理形式。这是一种新方法，一种思考产品审评和上市后管理流程的新方式。本文概述了风险评估和管理的几个方面，这些方面最近已被纳入FDA的流程中，这将简化审评并降低使用医疗器械所涉及的风险。这些方面包括开发一种新流程，以选择适用于个别器械申请的资源；更加重视临床研究的良好实验设计；以及持续开发生物材料数据库。
