Donawa M
Donawa & Associates Ltd, Rome, Italy.
Med Device Technol. 2001 Dec;12(10):24, 26-7.
At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.
在最近的一次医疗器械会议上，美国食品药品监督管理局（FDA）设备与放射健康中心（CDRH）主任大卫·费加尔博士表示，CDRH三分之一的员工将在五年内退休。这只是该中心面临的众多挑战之一。本文讨论了影响当前FDA设备政策和计划的关键因素、CDRH战略计划、标准计划的持续重要性以及CDRH的协调活动。
