FDA Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft
标准简介
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。标准截图
![Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft[附网盘链接]](/img/20210914103617hwtog.jpg)
标准文档说明
标准文档类型为Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft –Not for Implementation 1 Clarification of Radiation Control 2 Regulations 3 For Manufacturers of Diagnostic 4 X-Ray Equipment 5 Draft Guidance for Industry and 6 Food and Drug Administration Staff 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 10 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 11 the requirements of the applicable statutes and regulations. To discuss an alternative 12 approach, contact the FDA staff or Office responsible for this guidance as listed on the title 13 page. 14 15 I. Introduction 16 17 This draft guidance provides clarification to industry and FDA staff of the Federal Regulations that 18 relate to diagnostic x-ray systems and their major components. This draft guidance, when finalized, 19 will supersede FDA’s guidance entitled “Clarification of Radiation Control Regulations for 1
20 Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989). “For the 21 current edition of the FDA-recognized standards referenced in this document, see the FDA 2
22 Recognized Consensus Standards Database. 23 FDA’s guidance documents, including this draft guidance, do not establish legally enforceable 24 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 25 be viewed only as recommendations, unless specific regulatory or statutory requirements are 26 cited. The use of the word should in Agency guidances means that something is suggested or 27 recommended, but not required. 1
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm095312.htm. 2
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
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