Gross T P, Kessler L G
Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, MD 20850, USA.
Stud Health Technol Inform. 1996;28:17-24.
This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.
本关于美国食品药品监督管理局（FDA）医疗器械警戒的概述讨论了FDA的基本报告法规和程序。FDA的程序已发展到如今我们每年收到超过10万份报告的程度。文中还介绍了FDA如何检查总体报告中的数据模式以识别数据库中的信号，以及FDA针对这些问题可能采取的行动。新举措包括，例如，对报告进行分类的新方法以及开发国际统一术语的进展。
