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诊断X射线设备性能标准；征求意见和信息——美国食品药品监督管理局。拟议规则制定预先通知。

Diagnostic x-ray equipment performance standard; request for comments and information--FDA. Advance notice of proposed rulemaking.

出版信息

Fed Regist. 1997 Dec 11;62(238):65235-7.

PMID:10176581
Abstract

The Food and Drug Administration (FDA) is announcing its intention to propose amendments to the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to address changes in the technology and use of radiographic and fluoroscopic systems. The agency is issuing this advance notice of proposed rulemaking (ANPRM) in accordance with its policy of early public disclosure of rulemaking activities. The FDA is soliciting comments and information from interested persons concerning the subject matter of the proposed amendments.

摘要

美国食品药品监督管理局（FDA）宣布其打算对诊断X射线系统及其主要部件的性能标准提出修订建议。该机构采取这一行动是为了应对射线照相和荧光透视系统技术及使用方面的变化。该机构根据其早期公开规则制定活动的政策发布了这份拟议规则制定预先通知（ANPRM）。FDA正在就拟议修订的主题征求相关人士的意见和信息。

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