美国食品药品监督管理局对磁共振设备安全性的监管：过去、现在与未来。
FDA regulation of the safety of MR devices: past, present, and future.
作者信息
Athey T W
机构信息
C.L. McIntosh & Associates, Rockville, Maryland 20852, USA.
出版信息
Magn Reson Imaging Clin N Am. 1998 Nov;6(4):791-5.
PMID:9799856
Abstract
The history of the Food and Drug Administration's (FDA) regulation of safety issues for MR devices is reviewed in this article. The guidance documents and policies that FDA has used from 1982 to the present to ensure safety are summarized. The present status of FDA regulatory policies and apparent plans for the future are included.
摘要
本文回顾了美国食品药品监督管理局（FDA）对磁共振成像（MR）设备安全问题的监管历史。总结了FDA自1982年至今用于确保安全的指导文件和政策。还包括FDA监管政策的现状及未来的明显计划。
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